Circular No. 07/2007/TT-BYT guiding the practice of medicine, traditional medicine, and private medical equipment.

CIRCULAR

Guidelines on private medical practice, traditional medicine, and private medical equipment

_________________________

Based on Ordinance No. 07/2003/PL-UBTVQH11 dated February 25, 2003, on Private Medical and Pharmaceutical Practice;

Based on Decree No. 103/2003/NĐ-CP dated September 12, 2003, of the Government detailing the implementation of certain provisions of the Ordinance on Private Medical and Pharmaceutical Practice;

Based on Decree No. 49/2003/NĐ-CP dated May 15, 2003, of the Government stipulating the functions, tasks, authorities, and organizational structure of the Ministry of Health;

The Ministry of Health issues guidelines on private medical practice, traditional medicine, and private medical equipment as follows:

I. GENERAL PROVISIONS

1. Scope of regulation, applicability, and applicable subjects:

a) These guidelines provide detailed guidance on private medical practice, traditional medicine, and private medical equipment;

b) These guidelines apply to individuals and organizations in Vietnam, Vietnamese citizens abroad, and foreign individuals and organizations practicing private medical services, traditional medicine, and private medical equipment in Vietnam;

These guidelines also apply to privately established health facilities with humanitarian purposes, providing free medical examinations and treatments, free medication distribution for the poor and policy beneficiaries in Vietnam, and organizing charitable medical examination and treatment campaigns.

c) The field of private pharmaceutical practice, vaccines, medical products, and traditional pharmaceutical practice shall be governed by Circular No. 02/2007/TT-BYT dated January 24, 2007, of the Ministry of Health detailing the implementation of certain provisions regarding drug business conditions under the Drug Law and Decree No. 79/2006/NĐ-CP dated August 9, 2006, of the Government detailing the implementation of certain provisions of the Drug Law.

2. Principles of Guidance:

a) These guidelines only specify those items, clauses, and points that the Ordinance on Private Medical and Pharmaceutical Practice and Decree No. 103/2003/NĐ-CP dated September 12, 2003, of the Government detailing the implementation of certain provisions of the Ordinance on Private Medical and Pharmaceutical Practice (hereinafter referred to collectively as Decree No. 103/2003/NĐ-CP) entrust the Ministry of Health to guide the implementation;

b) Individuals and organizations practicing private medical services, traditional medicine, and private medical equipment must comply with the provisions of the Enterprise Law, Investment Law, Trade Law, Ordinance on Private Medical and Pharmaceutical Practice, Decree No. 103/2003/NĐ-CP, these guidelines, and other relevant regulatory documents.

II. FORMS OF MEDICAL PRACTICE ORGANIZATION

1. Forms of organization for private medical practice, traditional medicine, and private medical equipment:

a) Forms of organization for private medical practice are carried out according to Article 16 of the Ordinance on Private Medical and Pharmaceutical Practice;

b) Forms of organization for private traditional medical practice are carried out according to Clause 1, 2, 3, and 5 of Article 21 of the Ordinance on Private Medical and Pharmaceutical Practice;

c) Forms of organization for private medical equipment practice are carried out according to Article 34 of the Ordinance on Private Medical and Pharmaceutical Practice.

2. Forms of organization for specialized outpatient clinics:

Specialized outpatient clinics as stipulated in Clause 2 of Article 16 of the Ordinance on Private Medical and Pharmaceutical Practice include:

a) General internal outpatient clinic, internal specialty outpatient clinic;

b) Family medicine outpatient clinic, telemedicine consultation and treatment outpatient clinic, health care consultation outpatient clinic through information technology and telecommunications devices and medical equipment;

c) Surgical outpatient clinic;

d) Obstetrics and gynecology outpatient clinic, family planning outpatient clinic;

đ) Dental outpatient clinic;

e) Ophthalmology outpatient clinic;

g) Otorhinolaryngology outpatient clinic;

h) Plastic surgery outpatient clinic;

i) Rehabilitation and physiotherapy outpatient clinic;

k) Psychiatry outpatient clinic;

l) Oncology outpatient clinic;

m) Dermatology outpatient clinic;

n) Pediatrics outpatient clinic;

o) Diagnostic imaging outpatient clinic;

p) Laboratory: biochemistry, hematology, microbiology, immunology, allergy, histopathology.

3. Forms of organization for healthcare service facilities:

Healthcare service facilities as stipulated in Clause 4 of Article 16 of the Ordinance on Private Medical and Pharmaceutical Practice include:

a) Denture service facility;

b) Injection, bandaging, pulse counting, temperature measurement, blood pressure measurement service facility;

c) Home healthcare service facility;

d) Optical prescription service facility.

III. SPECIFIC CONDITIONS FOR ISSUING PRIVATE MEDICAL PRACTICE LICENSES

1. Individuals eligible for a private medical practice license must meet the general conditions set forth in Article 17 of the Ordinance on Private Medical and Pharmaceutical Practice and Article 5 of Decree No. 103/2003/NĐ-CP.

2. Academic qualifications and practical experience at legitimate medical examination and treatment facilities (hereinafter referred to collectively as medical examination and treatment facilities) of individuals applying for a medical examination and treatment practice license to open specialized outpatient clinics must meet the following specific conditions:

a) Family medicine outpatient clinic: A doctor or family medicine specialist has practiced for five years at a medical examination and treatment facility, including three years of family medicine specialization;

b) General internal outpatient clinic, internal specialty outpatient clinic, surgical outpatient clinic, obstetrics and gynecology outpatient clinic, family planning outpatient clinic, ophthalmology outpatient clinic, otorhinolaryngology outpatient clinic, dental outpatient clinic, oncology outpatient clinic, rehabilitation and physiotherapy outpatient clinic, psychiatry outpatient clinic, dermatology outpatient clinic, pediatrics outpatient clinic, telemedicine consultation and treatment outpatient clinic, health care consultation outpatient clinic through information technology and telecommunications devices and medical equipment, plastic surgery outpatient clinic: A doctor has practiced for at least five years at a medical examination and treatment facility, including three years of specialization. For plastic surgery outpatient clinics, doctors must have additional specialized certification in plastic surgery or a certificate of specialization in plastic surgery issued by a university of medicine;

c) Diagnostic Imaging Outpatient Clinic:

- X-ray Room: A doctor or Bachelor of Radiology (university graduate) has practiced for five years specializing in radiology at a medical examination and treatment facility;

- CT Scanner Room: A doctor has practiced for five years specializing in CT scanning at a medical examination and treatment facility;

- MRI Room: A doctor has practiced for five years specializing in MRI at a medical examination and treatment facility;

- Ultrasound Room: A doctor has practiced for five years specializing in ultrasound at a medical examination and treatment facility;

- Endoscopy Room: A doctor has practiced for five years specializing in endoscopy at a medical examination and treatment facility;

d) Laboratory: Doctor, Bachelor of Biology, Chemistry, Pharmacy, Medical Laboratory Technician (university graduate) who has practiced specialized laboratory work for at least five years at medical examination and treatment facilities;

đ) Midwifery house: Doctor, midwife with a minimum of a college degree who has practiced for at least five years at medical examination and treatment facilities, including at least three years specializing in obstetrics and gynecology;

The head of the midwifery house must be someone practicing full-time (not part-time outside regular working hours);

3. The qualifications and practical experience of those applying for a private healthcare service practice certificate under the organizational forms specified in Clause 3, Section II of this Circular must have at least two years of practical experience at medical examination and treatment facilities and meet the following specific conditions:

a) The head of a private injection (injection), bandage changing, pulse counting, temperature measurement, blood pressure measurement service facility must hold a minimum of a vocational college degree in medicine;

b) The head of a private home health care service facility must hold a minimum of a vocational college degree in medicine;

c) For dentists who have been practicing since before 1980, to be eligible to head a false tooth manufacturing service facility, they must have been at least 18 years old at that time and must have a confirmation letter from the People's Committee of the commune;

d) The head of a private optical equipment service facility must meet one of the following conditions:

- Hold a minimum of a vocational college degree in medicine and have worked in specialized ophthalmic facilities for at least two years;

- Hold a minimum of a vocational college degree in medicine and possess a certificate on medical equipment (equipment for measuring and diagnosing refractive errors of the eye) issued by a training institution designated by the Ministry of Health;

- Prior to the Circular No. 01/2004/TT-BYT dated January 6, 2004, of the Minister of Health on private medical and pharmaceutical practices (hereinafter referred to as Circular No. 01/2004/TT-BYT), the head of a private optical equipment service facility must possess a certificate on medical equipment (equipment for measuring and diagnosing refractive errors of the eye) issued by a training institution designated by the Ministry of Health and have a full-time employment contract with a person holding a minimum of a vocational college degree in medicine and having worked in specialized ophthalmic facilities for at least two years;

đ) The head of a private patient transportation service within the country and abroad must hold a university degree in medicine and have practiced for at least five years at medical examination and treatment facilities, and must have a certificate confirming completion of emergency resuscitation training;

4. The basis for determining practical experience is defined as follows:

a) For civil servants and employees who have retired or resigned or transferred to other jobs without continuing their specialized work, the period of practical experience will be based on the legal copy of the decision on retirement or resignation;

b) For those working at private medical facilities, the period of practical experience will be based on the confirmation letter of the head of the facility regarding the period of practical experience, accompanied by a legal copy of the labor contract or a legal copy of the social insurance record;

c) For civil servants, employees, and those currently working at state medical facilities, the period of practical experience will be based on the confirmation letter from the head of the agency agreeing to allow private medical practice outside regular working hours. The confirmation letter must clearly indicate the period of practical experience at the state medical facility;

5. Civil servants and employees currently working at state medical facilities may only be granted a private medical practice certificate outside regular working hours to become the head of one of the following individual business registration forms: specialized outpatient clinics (excluding midwifery houses); private healthcare service facilities (excluding patient transportation services within the country and abroad as stipulated in Clause 5, Article 16 of the Private Medical and Pharmaceutical Practice Ordinance);

6. For regions with particularly difficult economic and social conditions, economically disadvantaged regions, and ethnic minority areas as provided for in Article 12 of the Private Medical and Pharmaceutical Practice Ordinance, the Department of Health in these provinces may propose the Chairman of the Provincial People's Committee to specify the specific requirements for qualifications and practical experience to issue certificates for private medical and healthcare service practices in accordance with local realities for different types of private medical practices. Those granted a private medical practice certificate are only permitted to practice within that locality;

7. Depending on needs, management capabilities, and based on Clause 2, Article 2 of Decree No. 103/2003/NĐ-CP, the Chairmen of the People's Committees of Hanoi, Da Nang, Hai Phong, and Ho Chi Minh City may permit the Department of Health to expand the issuance of private medical practice certificates to individuals without permanent residence registration in those localities for certain types of private medical practices;

IV. SPECIFIC REQUIREMENTS FOR ISSUING PRIVATE TRADITIONAL MEDICINE PRACTICE CERTIFICATES

FOR DIAGNOSIS AND TREATMENT

1. Individuals applying for a private traditional medicine practice certificate for diagnosis and treatment must meet the general requirements stipulated in Article 22 of the Private Medical and Pharmaceutical Practice Ordinance and Article 5 of Decree No. 103/2003/NĐ-CP;

2. The qualifications and practical experience of those applying for a private traditional medicine practice certificate to open a traditional medicine hospital, a center for inheriting and applying traditional medicine, a traditional medicine clinic, a rehabilitation facility using acupuncture, massage, acupressure, qigong, herbal steam therapy, and other non-pharmaceutical traditional medicine service facilities (hereinafter referred to as traditional medicine service facilities not using drugs) must meet the following specific conditions:

a) The head of a traditional medicine hospital must hold a bachelor's degree in traditional medicine from a domestic or foreign institution and have at least five years of practical experience at legally recognized traditional medicine examination and treatment facilities (hereinafter referred to as traditional medicine examination and treatment facilities).

b) The head of the center for inheriting and applying traditional medicine must have one of the following qualifications or certificates: A diploma in vocational training in traditional medicine or higher, or a certificate in traditional medical expertise (licensed physician certificate) issued by the Ministry of Health or the Provincial Health Department before Circular No. 01/2004/QĐ-BYT took effect, or a licensed physician qualification issued by a training institution designated by the Ministry of Health and having at least five years of practice experience at healthcare facilities providing treatment with traditional medicine.

c) The head of the traditional medicine clinic or a traditional medicine service facility that does not use drugs must have one of the following qualifications or certificates: A diploma in vocational training in traditional medicine or higher, or a licensed physician qualification issued by a training institution designated by the Ministry of Health, or a certificate in traditional medical expertise (licensed physician certificate) issued by the Ministry of Health or the Provincial Health Department before Circular No. 01/2004/QĐ-BYT took effect and having at least five years of practice experience at healthcare facilities providing treatment with traditional medicine, or a certificate of hereditary prescription issued by the Ministry of Health or the Provincial Health Department according to the regulations of the Ministry of Health.

3. The basis for determining the period of practice shall be implemented in accordance with the provisions of Clause 4, Section 3 of this Circular.

4. Civil servants, public officials, and employees working at state-owned health facilities may only be granted a private practice certificate for traditional medicine to serve as the head of one of the following individual business registration forms: Traditional medicine clinic; non-drug traditional medicine service facility outside regular hours.

5. For regions with particularly difficult socio-economic conditions, regions with difficult socio-economic conditions, and ethnic minority areas as stipulated in Article 12 of the Private Medical and Pharmaceutical Practice Ordinance, the specific regulations on qualifications and practice periods shall be implemented in accordance with the provisions of Clause 5, Section 3 of this Circular.

V. CONDITIONS AND SCOPE OF PROFESSIONAL PRACTICE

PRIVATE MEDICAL PRACTICE

The conditions and scope of professional practice for private medical practice as prescribed in Clause 2, Article 7 of Decree No. 103/2003/NĐ-CP are detailed as follows:

1. Conditions and scope of professional practice for hospitals

1.1. Personnel and physical infrastructure conditions:

a) The hospital director must have a registered medical practice certificate for hospital examination and treatment.

b) The department head must be a specialist doctor who has practiced for five years at a healthcare facility, including three years of specialized practice. The department head must work regularly at the hospital (not part-time).

c) Surgeons must be doctors specializing in surgery or general practitioners with a surgical specialty certification from a University of Medicine, recommended by the head of the surgery department and approved by the hospital director. Surgeons trained abroad must have a specialty certificate, and for new surgical methods or advanced techniques, they must have a training program from their training institution.

d) General hospitals must have at least 31 beds.

đ) Specialized hospitals must have at least 21 beds. For specialized eye hospitals using high-tech techniques, there must be at least 10 beds.

e) Organizational and personnel structure must be appropriate to the scale of the hospital; those engaged in professional work must meet the conditions specified in Section VIII of this Circular.

g) Must comply with the Hospital Regulations and the regulations on medical technical procedures issued by the Ministry of Health.

h) Must ensure hygiene, ventilation, convenience for patients' movement, have playgrounds, parking spaces, and greenery. If the hospital is built in an urban area, it must be designed as a multi-story building but must reasonably arrange departments and rooms to ensure sterile conditions and environmental hygiene as required.

i) Must have fire prevention and firefighting certificates; certificates of wastewater treatment systems; contracts for medical waste disposal or incinerators for medical and household waste; permits for using medical X-ray equipment (if applicable).

l) Average usable area: 50-60m² per bed.

l) Must ensure professional activities within a centralized, continuous, and closed system within the hospital premises.

m) The hospital must have: Outpatient department - emergency - inpatient department, treatment departments, clinical laboratories, and pharmacy.

n) The operating room and anesthesia recovery department must be arranged with consecutive one-way operating rooms, reasonably and appropriately for the scope of professional activities registered.

- Emergency operating room, sterile operating room, contaminated operating room, otolaryngology operating room, oral-maxillofacial surgery operating room, ophthalmology operating room, obstetrics and gynecology operating room, endoscopy operating room, minor surgery operating room, planned delivery room must have an average area of 25-30m²per room; with floor tiles and wall tiles or waterproof materials ensuring sterile conditions up to the ceiling.

- Must have sufficient reception rooms, pre-anesthesia rooms, recovery rooms, sanitary facilities, and other rooms as required.

- All wards and rooms in the hospital must have a height of at least 3.1 meters.

o) Medical equipment in each department of the hospital must meet professional requirements and must be at least equivalent to district level hospitals as stipulated in Decision No. 437/2002/QĐ-BYT dated February 20, 2002, of the Minister of Health on the "List of Medical Equipment for General Hospitals at Provincial, District Levels, Regional Polyclinics, and Village Health Stations."

1.2. Scope of practice:

Must implement in accordance with the approved scope of professional activities by the Ministry of Health. The hospital must accept patients in critical condition and can only transfer them to another hospital after they have been stabilized.

2. Conditions and scope of professional practice for polyclinics:

2.1. Personnel and physical infrastructure conditions:

A polyclinic is a healthcare facility consisting of multiple specialized clinics (at least two) under the common responsibility of a director.

a) The head must have a medical practice certificate registered for a multi-specialty outpatient clinic;

b) The head of specialized outpatient departments must be a doctor who has practiced for five years at a medical examination and treatment facility, including three years in specialized practice; personnel performing professional tasks must meet the conditions stipulated in Section VIII of this Circular;

c) Specialized outpatient departments within general outpatient departments must ensure sufficient area, equipment, medical facilities, and conditions as specified for specialized outpatient departments in this Circular. In addition to the above requirements, general outpatient departments must have a reception area and emergency rooms with a minimum area of 12 square meters;², a patient observation room with a minimum area of 18 square meters² and a height not less than 3.1 meters (patients should not be retained for more than 24 hours), and must have anti-shock boxes and sufficient emergency drugs according to the registered specialty;

d) Must have a fire prevention and control certificate; must have a contract for medical waste disposal or a medical waste incinerator meeting the prescribed standards, as well as household waste; must have a permit to use medical X-ray equipment (if such equipment is available);

2.2. Scope of Practice:

Practice according to the list of specialties approved by the Department of Health;

3. Conditions and scope of professional practice for internal general outpatient departments, family medicine outpatient departments, internal specialized outpatient departments, telephone consultation and treatment clinics, and health care consultation clinics through information technology and telecommunication devices;

3.1. Personnel and infrastructure conditions:

a) The head must hold a medical practice certificate according to the requirements of each type of organizational form;

b) Personnel performing professional tasks must meet the conditions stipulated in Section VIII of this Circular;

c) Internal general outpatient departments, internal specialized outpatient departments, and family medicine outpatient departments must have appropriate medical equipment and facilities for their scope of practice, anti-shock boxes, and sufficient internal emergency drugs;

d) Must have a separate consultation room with a minimum area of 10 square meters² and a height not less than 3.1 meters. The consultation room must be separated from the family living area;

f) Must ensure conditions for handling waste and environmental hygiene as prescribed by law;

e) Internal general outpatient departments, internal specialized outpatient departments, and family medicine outpatient departments, if they have ultrasound or endoscopy, must have separate ultrasound and digestive endoscopy rooms, each with a minimum area of 10 square meters² and a height not less than 3.1 meters;

g) Telephone consultation and treatment clinics do not need to comply with points b, c, d, f, and e of Section 3.1, Clause 3 of this Section;

h) Health care consultation clinics through information technology, telecommunication devices, and medical equipment must be located within general outpatient departments or general hospitals, equipped with appropriate information technology, telecommunication, and medical equipment to ensure accuracy and meet the requirements for health care consultations;

3.2. Scope of Practice:

a) Internal general outpatient department:

- Health counseling;

- Emergency care, examination, and treatment of common internal diseases, without performing specialized procedures; cases beyond capacity must be referred to specialized outpatient departments or higher levels;

- Internal general outpatient departments are permitted to use electrocardiography, ultrasound, electroencephalography, and digestive endoscopy techniques within the permitted scope of professional activities;

- Electrocardiography, ultrasound, digestive endoscopy, and electroencephalography (no separate certification required, but the head or physician directly performing these techniques must have a certificate of specialized training from a medical examination and treatment facility equivalent to provincial or municipal level and confirmation of at least two years of practical experience in the specialty at a medical examination and treatment facility);

b) Family medicine outpatient department:

- Health counseling and health care at the outpatient department and at patients' homes;

- Emergency care, examination, and treatment of common internal diseases, without performing specialized procedures; cases beyond capacity must be referred to specialized outpatient departments or higher levels;

- Electrocardiography, ultrasound, digestive endoscopy, and electroencephalography (no separate certification required, but the head or physician directly performing these techniques must have a certificate of specialized training from a medical examination and treatment facility equivalent to provincial or municipal level and confirmation of at least two years of practical experience in the specialty at a medical examination and treatment facility);

c) Internal specialized outpatient departments: Examination, diagnosis, and treatment of diseases within the approved specialty;

d) Telephone consultation and treatment clinics, health care consultation clinics through information technology, telecommunication devices, and medical equipment: Physicians can only provide consultations in specialties they have registered and been trained in;

4. Conditions and scope of professional practice for surgical specialized outpatient departments;

4.1. Personnel and infrastructure conditions:

a) The head must hold a medical practice certificate registered for surgical specialized outpatient departments;

b) Personnel performing professional tasks must meet the conditions stipulated in Section VIII of this Circular;

c) Must have appropriate medical equipment and facilities for the scope of practice, anti-shock boxes, and sufficient surgical emergency drugs;

d) Surgical outpatient departments and minor surgery rooms must each have a minimum area of 10 square meters², emergency rooms and patient observation rooms must each have a minimum area of 12 square meters²; minor surgery and emergency rooms must be tiled or covered with waterproof materials to ensure sterile hygiene, with a height not less than 3.1 meters;

f) Must ensure conditions for handling waste and environmental hygiene as prescribed by law;

4.2. Scope of Practice:

a) Emergency care - initial surgical emergency care;

b) Examination and treatment of common wounds;

c) Splinting of small bone fractures;

d) Removal of splints according to the physician's instructions;

f) Hemorrhoid banding for degree I and II, cyst excision, and small superficial tumors;

e) Not to puncture large spreading abscesses;

5. Conditions and scope of professional practice for obstetric-gynecological specialized outpatient departments - family planning;

5.1. Personnel and infrastructure conditions:

a) The head must hold a medical practice certificate registered for obstetric-gynecological specialized outpatient departments - family planning;

b) Personnel performing professional tasks must meet the conditions stipulated in Section VIII of this Circular;

c) Must have sufficient medical equipment and devices appropriate to the scope of practice, with a first aid kit for shock and adequate specialized emergency medications;

d) Obstetric examination rooms, gynecological examination rooms, and family planning technical rooms must have an area of at least 10 square meters;², a height not less than 3.1 meters, and walls must be tiled or covered with waterproof materials ensuring sterile hygiene;

đ) Ensure fire prevention and explosion protection conditions, waste management, and environmental sanitation in accordance with legal regulations;

5.2. Scope of Practice:

a) Health education counseling, family planning;

b) Initial obstetric and gynecological emergency care;

c) Prenatal examinations and antenatal care management;

d) Gynecological diagnosis and treatment: Infections, reproductive tract infections;

đ) Insertion of vaginal medication;

e) Electrocoagulation for cervical ectopy treatment;

g) Cervical colposcopy, biopsy for cancer cell detection;

h) Obstetric ultrasound (the head or directly responsible doctor must hold a certificate of professional training from a provincial-level or higher equivalent healthcare facility and confirmation of at least two years of practical experience in the relevant specialty);

i) Insertion of intrauterine devices;

k) Induced abortion up to six weeks (from 36 to 42 days, counted from the first day of the last menstrual period);

6) Conditions and scope of specialized practice for dental, oral, and maxillofacial clinics:

6.1. Personnel and infrastructure conditions:

a) The head must have a valid medical practice certificate for dental, oral, and maxillofacial clinics;

b) Personnel performing professional tasks must meet the conditions stipulated in Section VIII of this Circular;

c) Must have sufficient specialized equipment appropriate to the scope of practice, with a first aid kit for shock and adequate specialized emergency medications;

d) Examination and treatment rooms must have an area of at least 10 square meters per dental chair and must be tiled or covered with waterproof materials ensuring sterile hygiene, with a height not less than 3.1 meters;² for each dental chair and must be tiled or covered with waterproof material to ensure sterile hygiene, with a height not less than 3.1 meters;

f) Must ensure conditions for handling waste and environmental hygiene as prescribed by law;

6.2. Scope of Practice:

a) General diagnosis and treatment, initial emergency care for oral and maxillofacial injuries;

b) Minor scar revision surgeries under 2 centimeters on the face;

c) Correction of jaw misalignment;

d) Surface laser treatment;

đ) Treatment of periodontal diseases;

e) Incision and drainage of abscesses, scaling, tooth extraction;

g) Denture fabrication;

h) Oral and facial reconstructive surgery;

i) Tooth repair and endodontic treatment;

k) Minor oral and maxillofacial surgical procedures.

7. Conditions and scope of specialized practice for otolaryngology clinics:

7.1. Personnel and infrastructure conditions:

a) The head must have a valid medical practice certificate for otolaryngology clinics;

b) Personnel performing professional tasks must meet the conditions stipulated in Section VIII of this Circular;

c) Must have sufficient medical equipment and devices appropriate to the scope of practice, with a first aid kit for shock and specialized emergency medications;

d) Examination room must have an area of at least 10 square meters, minor surgery room must have an area of at least 10 square meters, emergency room must have an area of at least 12 square meters, all walls must be tiled or covered with waterproof materials ensuring sterile hygiene, with a height not less than 3.1 meters;², the minor surgery room must have an area of at least 10 square meters²đ) Ensure waste management and environmental sanitation conditions in accordance with legal regulations;²7.2. Scope of Practice:

a) Initial emergency care for ear, nose, and throat conditions;

b) General diagnosis and treatment:

- Sinusitis, sinus puncture, cyst fluid aspiration;

- Incision and drainage of acute otitis media;

- Incision and drainage of peritonsillar abscess;

- Simple polyp removal, sebaceous cyst, follicular cyst, lipoma removal in the ear, nose, and throat region;

- Nasal bleeding control;

- Foreign body removal from the ear, nose, and throat region. Not including foreign body removal from the trachea or esophagus;

- Thermal or laser throat ablation;

- Suturing of head and neck wounds less than 5 centimeters;

- Adenoidectomy.

8. Conditions and scope of specialized practice for ophthalmology clinics:

8.1. Personnel and infrastructure conditions:

a) The head must have a valid medical practice certificate for ophthalmology clinics;

c) Must have sufficient medical equipment and devices appropriate to the scope of practice, with a first aid kit for shock and specialized emergency eye medications;

8.2. Scope of Practice:

b) Personnel performing professional tasks must meet the conditions stipulated in Section VIII of this Circular;

a) Initial emergency care and general eye treatment;

d) Examination room must have an area of at least 10 square meters, minor surgery room must have an area of at least 10 square meters, emergency room must have an area of at least 12 square meters, all walls must be tiled or covered with waterproof materials ensuring sterile hygiene, with a height not less than 3.1 meters;², the minor surgery room must have an area of at least 10 square meters²đ) Ensure waste management and environmental sanitation conditions in accordance with legal regulations;²7.2. Scope of Practice:

f) Must ensure conditions for handling waste and environmental hygiene as prescribed by law;

b) Subconjunctival injection, periocular injection, retrobulbar injection;

c) Removal of conjunctival and corneal foreign bodies, chalazion incision and drainage;

d) Lacrimal duct irrigation.

9. Conditions and scope of specialized practice for aesthetic surgery clinics:

9.1. Personnel and infrastructure conditions:

a) The head must have a valid medical practice certificate for aesthetic surgery clinics;

c) Must have sufficient medical equipment and devices appropriate to the scope of practice, with a first aid kit for shock and specialized emergency medications;

, operating room must have an area of at least 12 square meters;

b) Personnel performing professional tasks must meet the conditions stipulated in Section VIII of this Circular;

đ) Ensure fire prevention and explosion protection conditions, waste management, and environmental sanitation in accordance with legal regulations;

d) Examination room must have an area of at least 10 square meters, minor surgery room must have an area of at least 10 square meters, emergency room must have an area of at least 12 square meters, all walls must be tiled or covered with waterproof materials ensuring sterile hygiene, with a height not less than 3.1 meters;²e) Aesthetic surgery that alters identifiable features listed on identification cards can only be performed after the person requesting the surgery has submitted a request to the police station issuing their ID card;²9.2. Scope of Practice:²7.2. Scope of Practice:

a) Lip tattooing, eyelash tattooing, blackhead extraction;

b) Hair implantation, eyebrow implantation;

c) Cheek augmentation, nasal bridge augmentation;

d) Treatment of upper and lower eyelid wrinkles, creation of double eyelids from single eyelids;

đ) Cannot perform plastic surgeries such as breast augmentation; breast lift; nipple reduction; abdominoplasty; buttock and thigh lift; buttock and thigh skin tightening; fat removal; face lifting.

10. Conditions and scope of specialized practice for rehabilitation and physiotherapy clinics:

10.1. Personnel and infrastructure conditions:

a) The head must have a valid medical practice certificate for rehabilitation and physiotherapy clinics;

c) Must have sufficient medical equipment and devices appropriate to the scope of practice, with a first aid kit for shock and specialized emergency medications;

d) Must have an emergency room, physiotherapy room, rehabilitation room, and functional diagnostic room. Each room must have an area of at least 10 square meters, with a height not less than 3.1 meters; the physical therapy room must have an area of at least 40 square meters, and the emergency room must have walls tiled or covered with waterproof materials ensuring sterile hygiene;

10.2. Scope of Practice:

b) Personnel performing professional tasks must meet the conditions stipulated in Section VIII of this Circular;

a) Care for central and peripheral nervous system paralysis syndromes;

b) Care for chronic musculoskeletal diseases.², with a height not less than 3.1 meters; specifically, the physical therapy treatment room must have an area of at least 40 square meters² and the emergency room must have walls tiled or covered with waterproof material to ensure sterile hygiene;

f) Must ensure conditions for handling waste and environmental hygiene as prescribed by law;

10.2. Scope of Practice:

a) Care for central and peripheral nervous system paralysis syndromes;

b) Care for chronic musculoskeletal diseases;

c) Post-operative care shall continue to focus on functional recovery;

d) Implement techniques: Physical therapy methods approved and therapeutic activities;

11. Conditions and scope of practice for diagnostic imaging clinics

11.1. Personnel and infrastructure conditions:

a) The head must have a medical practice certificate allowing registration of a diagnostic imaging clinic;

b) Facilities using medical X-ray machines, CT Scanners must have a usage permit issued by the Department of Science and Technology where the machine is located, and other safety conditions for the room according to radiation safety laws;

c) Personnel performing specialized tasks, infrastructure, medical equipment, personal protective equipment must comply with radiation safety laws;

d) The ultrasound machine room must have an area of at least 10m²;

f) Must ensure conditions for handling waste and environmental hygiene as prescribed by law;

11.2. Scope of practice:

a) Radiography, computed tomography, magnetic resonance imaging diagnosis;

b) Doppler ultrasound, general ultrasound, diagnostic endoscopy;

c) Intravenous contrast media shall not be used in the diagnostic imaging clinic;

d) Ultrasound-guided puncture, endoscopic surgery, bronchoscopy, angiographic interventions causing bleeding shall not be performed;

đ) Bachelor of Radiology (university graduate) shall not make diagnostic conclusions;

12. Conditions and scope of practice for mental health specialty clinics

12.1. Personnel and infrastructure conditions:

a) The head must have a medical practice certificate allowing registration of a mental health specialty clinic;

b) The consultation room must have an area of at least 10m², height not less than 3.1m. Suitable desks and chairs and medical equipment such as internal medicine clinics, neurological examination tools;

c) The functional testing room must have an area of at least 10m² (if available), height not less than 3.1m. Suitable desks and chairs for electroencephalogram machines, cerebral blood flow recording machines and accompanying materials;

d) The psychological and physical therapy testing room must have an area of at least 10m² (if available). Must have soothing colors, sufficient lighting, and suitable desks, beds;

đ) Must have adequate medical equipment suitable for the scope of practice, including anti-shock drugs and emergency specialty drugs;

e) Ensure waste management and environmental hygiene conditions in accordance with the law;

12.2. Scope of practice:

a) Initial mental health emergency care, identifying cases exceeding the capacity to refer to higher-level mental health specialties;

b) Functional testing related to mental health, psychological testing, electroencephalogram, cerebral blood flow recording;

c) Diagnosing and prescribing treatment for mental illnesses and epilepsy in accordance with the Ministry of Health's regulations;

d) Providing advice on preventing mental illness;

đ) Conducting psychological therapy;

13. Conditions and scope of practice for oncology specialty clinics

13.1. Personnel and infrastructure conditions:

a) The head must have a medical practice certificate allowing registration of an oncology specialty clinic;

b) Specialized personnel must have a degree in oncology;

c) The oncology specialty clinic must have an area of at least 10m² and a height not less than 3.1m. Suitable desks, chairs, and beds for specialized examinations. If conducting gynecological examinations, there must be a separate examination room;

d) The functional testing room must have an area of at least 10m² (if available) and a height not less than 3.1m. Suitable desks and chairs and electroencephalogram machines, cerebral blood flow recording machines and accompanying materials;

đ) The procedure room must have an area of at least 10m² and a height not less than 3.1m;

e) The emergency room must have an area of at least 10m² and a height not less than 3.1m, and must comply with infection control regulations;

g) All rooms mentioned above must have walls tiled with ceramic tiles or waterproof materials ensuring sterile conditions, with a height of 3.1m or more;

h) Must have adequate medical equipment suitable for the scope of practice, including anti-shock drugs and emergency specialty drugs;

i) Ensure waste management and environmental hygiene conditions in accordance with the law;

13.2. Scope of practice:

a) Provide health consultations and disseminate knowledge about cancer prevention;

b) Early detection of common cancers;

c) Collect samples for cell and pathological tissue analysis of certain types of cervical, rectal, vulvar, breast, and lymph node cancers. Cell and pathological tissue test results must be concluded by a specialist pathologist-cytologist;

d) Regularly examine and follow up on cancers that have been or are being treated;

14. Conditions and scope of practice for dermatology specialty clinics

14.1. Personnel and infrastructure conditions:

a) The head must have a medical practice certificate allowing registration of a dermatology specialty clinic;

b) Specialized personnel must have a degree in dermatology;

c) The dermatology specialty clinic must have an area of at least 10m² and a height not less than 3.1m. Suitable desks, chairs, and beds for specialized examinations. If conducting gynecological examinations, there must be a separate examination room;

d) All mentioned clinics must have walls tiled with ceramic tiles or waterproof materials ensuring sterile conditions, with a height of 3.1m or more;

đ) Must have adequate medical equipment suitable for the scope of practice, including anti-shock drugs and emergency specialty drugs;

e) Ensure waste management and environmental hygiene conditions in accordance with the law;

14.2. Scope of practice:

Consultation and treatment of skin diseases, leprosy, occupational skin diseases, sexually transmitted diseases;

15. Conditions and scope of practice for cardiology, pediatrics, tuberculosis and lung disease specialty clinics and other internal medicine specialty clinics

Based on the conditions and scope of practice stipulated in Clause 3, Section V of this Circular, the Director of the Provincial Department of Health shall consider and decide the scope of practice for each type of specialty clinic based on specific conditions in the certificate of eligibility for practice;

16. Conditions and scope of practice for laboratory clinics

16.1. Personnel and infrastructure conditions:

a) The head must have a medical practice certificate allowing registration of a laboratory clinic;

b) Personnel performing professional tasks must meet the conditions stipulated in Section VIII of this Circular;

c) Have medical equipment and devices suitable for the scope of practice. The infrastructure must meet the conditions as stipulated in the Laboratory Work Regulation issued together with Decision No. 1895/BYT-QD dated September 19, 1997, of the Minister of Health.

d) Ensure conditions for handling waste and environmental hygiene in accordance with the provisions of the law.

16.2. Scope of Practice:

Conduct blood tests, biochemistry tests, microbiology tests, parasitology tests, histopathology (microscopic).

17. Conditions and Professional Scope of Practice for Midwives

17.1. Human Resources and Infrastructure Conditions:

a) The head must have a Medical Practice Certificate registered as a midwife and must be practicing full-time (not practicing outside regular working hours).

b) Personnel performing professional tasks must meet the conditions stipulated in Section VIII of this Circular;

c) A midwife facility must have at least six rooms:

- An obstetric examination room with an area of at least 10 square meters.²;

- A gynecological examination room with an area of at least 10 square meters.²;

- A delivery room with an area of at least 16 square meters.²;

- A family planning technique room with an area of at least 10 square meters.²;

- A postpartum ward (for labor, post-delivery, post-abortion) with an area of at least 5 square meters² per bed.

- A counseling room or corner on reproductive health with an area of at least 5 square meters.²;

- All examination and technique rooms mentioned above (except the counseling room or corner) must have walls tiled with glazed tiles to a height of at least 2 meters.

d) Must have sufficient medical equipment and devices suitable for the scope of practice, including a shock box and sufficient emergency drugs.

đ) Ensure fire prevention and explosion protection conditions, waste management, and environmental sanitation in accordance with legal regulations;

17.2. Scope of Practice:

a) Obstetric examinations, pregnancy management;

b) Initial emergency care, obstetric first aid;

c) Tetanus vaccination;

d) Urine protein test;

đ) Normal delivery assistance;

e) Removal of retained placental tissue after delivery; after miscarriage;

g) If there is a specialist obstetrician-gynecologist, then intrauterine device insertion, difficult delivery assistance, abortion or medical termination of pregnancy up to 6 weeks (embryo from 36 to 42 days, counted from the first day of the last menstrual period) can be performed.

18. Conditions and Professional Scope of Practice for Injection and Dressing Service Facilities

18.1. Human Resources and Infrastructure Conditions:

a) The head must have a Medical Practice Certificate registered for injection and dressing service facilities;

b) Personnel performing professional tasks must meet the conditions stipulated in Section VIII of this Circular;

c) There must be an injection and dressing room with an area of at least 10 square meters.²;

d) Must have sufficient equipment and ensure sterility.

f) Must ensure conditions for handling waste and environmental hygiene as prescribed by law;

18.2. Scope of Practice

Only perform according to a doctor's prescription; cannot conduct diagnosis or prescribe medication.

19. Conditions and Professional Scope of Practice for Denture Service Facilities

19.1. Human Resources and Infrastructure Conditions:

a) The head must have a Medical Practice Certificate registered for denture service facilities;

b) Personnel performing professional tasks must meet the conditions stipulated in Section VIII of this Circular;

c) The examination and denture fitting room must have an area of at least 10 square meters,²the denture making room must have an area of at least 10 square meters.²;

d) Must have sufficient medical equipment and devices suitable for the scope of practice.

f) Must ensure conditions for handling waste and environmental hygiene as prescribed by law;

19.2. Scope of Practice

a) Making false teeth, dentures, fitting, fixing;

b) For those dental technicians in Ho Chi Minh City who were licensed to practice before 1980 and have been trained and tested by the Ho Chi Minh City Department of Health (1985, 1986) and received a "Skill Certification" meeting the requirements, if they wish to expand their scope of practice to include filling cavities up to degree 2, extracting single-rooted loose teeth, they must supplement their professional qualifications and ensure adequate medical equipment and have a shock box as required. The Ho Chi Minh City Department of Health will organize professional training and skill testing for these dental technicians in collaboration with the Dental School of Ho Chi Minh City University of Medicine and Pharmacy. Based on each person's level and capability, the Ho Chi Minh City Department of Health will issue a practice certificate. Extraction of single-rooted loose teeth must be accompanied by a condition that the denture facility must enter into a professional support agreement with the nearest healthcare facility (with dental services) to ensure patient safety in case of complications.

20. Conditions and Professional Scope of Practice for Home Healthcare Service Facilities

20.1. Human Resources and Infrastructure Conditions:

a) The head must have a Medical Practice Certificate for home healthcare services;

b) Personnel performing professional tasks must meet the conditions stipulated in Section VIII of this Circular;

c) Must have sufficient medical equipment and devices suitable for the scope of practice.

20.2. Scope of Practice:

Provide home healthcare services according to a doctor's prescription; cannot conduct diagnosis or prescribe medication.

21. Conditions and Professional Scope of Practice for Optical Dispensing Services

21.1. Human Resources and Infrastructure Conditions:

a) The head must have a Medical Practice Certificate for home healthcare services;

b) Personnel performing professional tasks must meet the conditions stipulated in Section VIII of this Circular;

c) Must have sufficient equipment and devices for refractive eye examination, measurement and fitting of glasses, and warranty of optical dispensing services approved within the scope of practice.

d) The store must have an area of at least 15 square meters.²;

đ) Must have fire prevention and firefighting equipment, ensuring environmental hygiene.

21.2. Scope of Practice:

Measure refractive errors, fit and warranty optical dispensing services, advise on the use of glasses.

22. Conditions and Professional Scope of Practice for Emergency and Patient Transport Services within the Country and Overseas.

22.1. Human Resources and Infrastructure Conditions:

a) The head must have a Medical Practice Certificate registered for emergency and patient transport services within the country and overseas;

b) Must have sufficient doctors and healthcare professionals specializing in emergency resuscitation, transportation means, medical equipment, devices, shock boxes, and sufficient emergency drugs to ensure patient safety during transportation and maintain environmental hygiene.

c) Must have a professional support agreement with state hospitals and aviation service companies for transporting patients overseas;

d) Before transferring patients, the emergency and patient transport service facility must contact the receiving healthcare facility in advance.

22.2. Scope of Practice:

Provide emergency and patient transport services within the country and overseas.

23. Conditions and Professional Scope of Practice for Organizing Charity Medical Examination and Treatment Campaigns

23.1. Human Resources and Infrastructure Conditions:

a) Must have sufficient doctors and healthcare professionals specializing in relevant fields;

b) Must have sufficient transportation means, medical equipment, devices, shock boxes, and sufficient emergency drugs to ensure patient safety, free medications, and maintain environmental hygiene at the examination and treatment site.

23.2. Scope of Practice:

Conducting medical examinations and treatments according to the specialties approved by the Department of Health.

VI. CONDITIONS AND SCOPE OF PROFESSIONAL PRACTICE FOR PRIVATE TRADITIONAL MEDICINE DIAGNOSIS AND TREATMENT

PRIVATE PRACTICE OF TRADITIONAL MEDICINE

The conditions and scope of professional practice for private traditional medicine diagnosis and treatment as stipulated in Clause 2, Article 7 of Decree No. 103/2003/NĐ-CP are detailed as follows:

1. Conditions and scope of professional practice for traditional medicine hospitals.

1.1. Conditions regarding personnel and infrastructure:

a) The hospital director must be a doctor of traditional medicine with a practice certificate for traditional medicine diagnosis and treatment registered at the hospital;

b) The head of the department must be a specialist doctor with at least five years of practical experience, including three years in the specialty;

c) The head of the pharmacy department must be a university-level pharmacist with at least five years of practical experience at a healthcare or pharmaceutical facility;

d) Personnel engaged in professional work must meet the conditions specified in Section VIII of this Circular;

đ) Organizational structure and personnel appropriate to the scale of the hospital;

e) A traditional medicine hospital must have at least 21 inpatient beds and the following departments and units:

- Outpatient examination and treatment department:

+ The outpatient examination and treatment department must be arranged as a separate unit, comprising rooms: Emergency room with a first aid cabinet containing the prescribed number of emergency medications, oxygen tank, blood pressure monitor; consultation room; outpatient treatment room (separate male and female patient rooms). Each room must have beds, acupuncture needles, electro-acupuncture machines, and suitable equipment;

+ The area of each room in the outpatient examination and treatment department must be at least 10m², well-ventilated, and clean;²- Outpatient treatment unit including departments: Internal Medicine, Surgery, Gynecology, Pediatrics, Acupuncture and Rehabilitation, Ophthalmology, etc., depending on the scale of the hospital but must minimally include the General Internal Medicine and General Surgery Departments. Inpatient departments must be arranged separately, with each department having separate male and female patient rooms; ensuring a minimum usable area of 5m² per bed;

+ Administrative office of the department must have sufficient desks, chairs, and filing cabinets;²:

+ Operating room and surgery room (if available) must meet the conditions specified in Point n, Clause 1.1, Item V of this Circular;

+ Must have sufficient medical equipment as prescribed;

- Pharmacy and supplies department:

+ The production and preparation unit of medicines must be supervised by a university-level pharmacist or a person who has been issued a Certificate of Traditional Doctor or Traditional Pharmacist by the Ministry of Health or the Department of Health before Circular No. 01/2004/TT-BYT took effect, equipped with suitable facilities, arranged as follows:

* Prescription counter: Must have a prescription cabinet complying with regulations;

* Raw material warehouse (herbal materials and semi-finished products): Must be protected from sunlight, heat, moisture, and must be ventilated, with shelves to prevent mold, insects, and pests, clearly labeled to avoid confusion;

* Production and preparation area must be clean, not affecting the quality of the medicine, and must have a preliminary processing and quality control area for herbal materials before production;

+ Finished product warehouse (including tablets);

+ Supplies warehouse;

+ Separate cabinet for toxic medicines for easy use, inspection, and verification;

- Ancillary clinical department with rooms: Diagnostic imaging room, microbiology room, biochemistry room, hematology room;

- Administrative finance room;

g) Must ensure hygiene, ventilation, convenience for patients' movement, with playgrounds, parking areas, green spaces, and must comply with environmental sanitation conditions as prescribed;

h) Must have fire prevention and extinguishing certification; confirmation of wastewater treatment system construction; have a contract for medical waste disposal or incinerator; have a permit for using medical X-ray equipment issued by the Department of Science and Technology;

i) Average usable area: 50 - 60m²/bed; the height of wards and rooms in the hospital must not be less than 3.1m;

k) Must ensure professional activities operate in a centralized, continuous, and closed-loop manner within the hospital premises.² Private traditional medicine hospitals can carry out professional activities as prescribed in the "Regulations on Functions, Tasks, and Organizational Structure of Traditional Medical Hospitals under Provincial Departments of Health" issued together with Decision No. 1529/1999/QĐ-BYT dated May 25, 1999, by the Minister of Health.

2. Conditions and scope of professional practice for traditional medicine inheritance and application centers (hereinafter referred to as Traditional Medicine Centers):

1.2. Scope of practice:

2.1. Conditions regarding personnel and infrastructure:

a) The head must hold a practice certificate for traditional medicine diagnosis and treatment registered at the Traditional Medicine Center;

c) The Traditional Medicine Center must have the following specialized units:

- Inheritance unit;

b) Personnel performing professional tasks must meet the conditions stipulated in Section VIII of this Circular;

- Traditional medicine diagnosis and treatment unit;

- Rehabilitation and functional recovery unit using traditional medicine.

Depending on conditions, the Traditional Medicine Center may also have the following units:

- Professional training unit (operating according to the Education Law);

- Medicinal product production and sales unit;

- Herbal cultivation unit;

d) Conditions for each specialized unit of the Traditional Medicine Center:

- Inheritance unit: Supervised by a traditional doctor (holding a traditional doctor certificate issued by the Ministry of Health or the Department of Health before Circular No. 01/2004/TT-BYT took effect) or a doctor of traditional medicine; must have a team of highly qualified and reputable traditional doctors;

- Diagnosis and treatment unit:

+ Supervised by a doctor of traditional medicine, traditional medical assistant, or traditional doctor (holding a traditional doctor certificate issued by the Ministry of Health or the Department of Health before Circular No. 01/2004/TT-BYT took effect) with at least five years of practical experience;

+ The diagnosis and treatment room must be arranged separately, ensuring an area of at least 10m² for each doctor to conduct consultations and treatments;

+ Equipment includes: Examination table, bed, chair for patients.

+ The consultation room must be arranged separately, ensuring an area of at least 10 square meters² for a doctor to examine and treat patients;

+ Equipment includes: Examination table, examination bed, patient chair.

+ There must be a waiting area for patients;

- The rehabilitation and functional recovery unit shall be managed by a physician of traditional medicine, a medical officer of traditional medicine, or a licensed traditional doctor (holding a license issued by the Ministry of Health or the Department of Health before Circular No. 01/2004/TT-BYT took effect) with at least five years of practice experience at the rehabilitation and functional recovery facility:

+ Having premises and equipment suitable for the scope of practice;

+ Having separate acupuncture rooms and massage rooms for men and women; these rooms must ensure hygiene, cleanliness, and ventilation;

+ Acupuncture beds and massage tables must meet the following requirements: height of 70 cm, length of 2 meters, and width of at least 70 cm; the average usable area for each bed must be at least 4 square meters;²;

+ Acupuncture tools: sterilization pot for needles, sterile needle tray, non-sterile needle tray, clean cotton swab box and dirty cotton swab box; each patient must have their own set of needles; Kose forceps, acupuncture machine (if available);

+ Steam room and system for generating steam for patients to inhale, ensuring rationality and safety;

+ Area for guiding and practicing health exercises: minimum area of 30 square meters, clean and ventilated;²,

- The pharmaceutical production unit shall be managed by a university pharmacist or a licensed pharmacist with at least five years of practice experience, and personnel responsible for weighing and dispensing drugs must hold a pharmacy assistant degree or equivalent traditional medicine practitioner qualification, and appropriate equipment must be provided as follows:

+ Medicine dispensing room: Must ensure hygiene, ventilation, and have medicine cabinets or containers with lids that are clearly labeled and placed on shelves;

+ Raw material warehouse (herbs and semi-finished products): Must ensure hygiene, cleanliness, and ventilation, with shelves to prevent mold, pests, and insects, and clearly label the name of raw materials to avoid confusion;

+ There must be a pre-processing area and a quality control process for herbs before they are put into production;

+ Production and packaging areas for finished herbal medicines must ensure hygiene and not affect the quality of the drugs, and comply with relevant laws and regulations on pharmaceuticals;

d) Other conditions:

- Having a clean water supply meeting hygiene standards;

- Having appropriate equipment;

- Fire prevention and explosion protection measures, as well as waste management, must comply with relevant laws and regulations.

2.2. Scope of Practice:

a) Outpatient diagnosis and treatment using traditional medicine within the scope of practice specified in the Certificate of Eligibility for Practice;

b) Manufacturing and selling herbal medicines registered by the Ministry of Health for circulation; selling herbal medicines registered by the Ministry of Health for circulation.

3. Conditions and Scope of Professional Practice for Traditional Medicine Clinics

3.1. Personnel and Infrastructure Conditions:

a) The head must hold a certificate for outpatient diagnosis and treatment using traditional medicine registered for the traditional medicine clinic;

b) Personnel performing professional tasks must meet the conditions stipulated in Section VIII of this Circular;

c) The consultation room must be separate with a minimum area of 10 square meters per doctor, ensuring ventilation, hygiene, and equipped with sufficient desks and chairs, and a waiting area for patients;² d) There must be medicine cabinets or containers with lids that are clearly labeled and placed on shelves, ensuring hygiene and ventilation;

a) Outpatient diagnosis and treatment within the scope of practice specified in the Certificate of Eligibility for Practice; If acupuncture or acupressure methods are used, the conditions specified in Point c, Clause 4.1, Section VI of this Circular must be met;

3.2. Scope of Practice:

b) Practitioners using family-prescribed remedies can only diagnose and treat using those specific remedies;

c) Compounding raw herbs into decoctions and weighing prescriptions for patients;

d) Using finished traditional medicine products from other facilities that have been registered by the Ministry of Health for circulation to serve diagnosis and treatment;

e) In cases where pre-packaged products are produced directly for patients (such as pills, powders, etc.), registration with the Department of Health regarding the formula, production process (including explanations about infrastructure and equipment), efficacy, dosage, contraindications, and drug labels must be made. After review and approval by the Department of Health, production may commence. These medicines are solely for direct patient use and cannot be sold on the market according to the provisions of the Drug Law.

4. Conditions and Scope of Professional Practice for Non-Medicated Traditional Medicine Service Facilities

a) The head must hold a certificate for outpatient diagnosis and treatment using traditional medicine registered for non-medicated traditional medicine service facilities;

4.1. Personnel and infrastructure conditions:

c) Having premises and equipment suitable for the scope of practice:

b) Personnel performing professional tasks must meet the conditions stipulated in Section VIII of this Circular;

- Having separate acupuncture and massage rooms; these rooms must ensure cleanliness and ventilation; the average usable area for each room must be at least 4 square meters;

- Acupuncture beds and massage tables must be 70 cm high, 2 meters long, and at least 70 cm wide;².

- Acupuncture tools: sterilization pot for needles, sterile needle tray, non-sterile needle tray, clean cotton swab box and dirty cotton swab box; each patient must have their own set of needles; Kose forceps, acupuncture machine (if available);

- Steam room and system for generating steam (if offering traditional steam therapy services); the steam generation system must be inspected and confirmed safe, with an alarm system.

Permitted to use traditional medicine methods consistent with their training level and equipment capabilities within the scope of practice specified in the Certificate of Eligibility for Practice.

4.2. Scope of Practice:

VII. CONDITIONS AND SCOPE OF PROFESSIONAL PRACTICE FOR PRIVATE HEALTHCARE EQUIPMENT

The conditions and scope of professional practice for private healthcare equipment stipulated in Clause 2, Article 7 of Decree No. 103/2003/NĐ-CP are detailed as follows:

1. Scope of Application for Private Healthcare Equipment

Private healthcare equipment businesses include the sale of various types of machines, equipment, tools, supplies, and specialized transportation means serving diagnosis, treatment, rehabilitation, scientific research, and training in the field of healthcare, specifically:

a) Medical equipment includes: Various types of machines, equipment, or integrated systems serving diagnosis, treatment, rehabilitation, scientific research, and training in the healthcare sector;

Medical equipment business establishments include the sale of various types of machines, equipment, tools, materials, and specialized transportation means serving medical examinations and treatments, specifically as follows:

a) Medical equipment includes: Various types of machines, equipment, or integrated systems serving diagnostic, therapeutic, rehabilitation, scientific research, and training activities in the field of healthcare;

b) Specialized transportation equipment includes: Ambulances (ambulance cars, motorized boats, motorized ambulances, ambulance cars); Mobile medical equipment (mobile X-ray machines, mobile testing units, vaccine transport vehicles, etc.);

c) Medical tools and supplies include: Various types of medical tools, supplies, and chemicals used for specialized medical work in diagnosis and treatment, and health care;

d) Implantable medical devices include: Artificial bones, bone fixation plates and screws, heart valves, pacemakers, angioplasty balloons, cochlear implants, intraocular lenses (depending on the development of medical materials science, the Ministry of Health will update this list annually);

2. Conditions and scope of professional practice for businesses engaged in medical equipment trade

c) The Traditional Medicine Center must have the following specialized units:

a) Personnel:

- The person responsible for technical matters must have one of the following qualifications: A bachelor's degree in biomedical electronics; A bachelor's degree in engineering, a bachelor's degree in Medicine or Pharmacy, and a certificate in medical equipment training issued by legitimate training institutions or an equivalent certificate from abroad, with a minimum training period of one month;

For those who hold the aforementioned qualifications and have worked directly in medical equipment technology or management at legitimate healthcare facilities (public and private) for three years or more, confirmed by their unit head, they are not required to have a certificate in medical equipment training;

- Must have technical staff capable of guiding installation, warranty, and maintenance of medical equipment sold by the business;

b) Technical infrastructure:

- Must have appropriate headquarters and warehouses that meet conditions for properly storing medical equipment; must have all necessary technical tools and equipment to ensure installation, warranty, and maintenance of medical equipment can be carried out; must have fire prevention and explosion protection equipment and ensure environmental hygiene according to legal regulations;

2.2. Scope of Practice:

- For imported goods: Businesses may trade medical equipment, tools, supplies, and accompanying chemical test kits imported in accordance with Decree No. 12/2006/NĐ-CP dated January 23, 2006, of the Government detailing the implementation of the Law on Trade regarding international trade activities and related agency, purchase-sale, processing, and transit activities with foreign countries, Circular No. 08/2006/TT-BYT dated June 13, 2006, of the Ministry of Health guiding the importation of vaccines, medical products, chemicals, insecticides, and sterilizers used in medical household and medical equipment fields, and Circular No. 09/2006/TT-BYT dated July 11, 2006, of the Ministry of Health amending and supplementing Part IV and Appendix 7 of Circular No. 08/2006/TT-BYT dated June 13, 2006, of the Ministry of Health guiding the importation of vaccines, medical products, chemicals, insecticides, and sterilizers used in medical household and medical equipment fields;

- For domestically produced goods: Businesses may trade medical equipment that has been registered for circulation by the Ministry of Health;

- For specialized transportation equipment: Only businesses authorized to trade such items may engage in this activity;

- For implantable medical tools and supplies: Only businesses meeting the conditions stipulated in this Circular, having suitable storage conditions for each type of implantable tool and supply, and directly authorized by manufacturers may engage in this activity;

3. Conditions and scope of professional practice for businesses producing medical equipment.

3.1. Personnel and Infrastructure Conditions:

a) Personnel:

- The person responsible for technical matters must have one of the following qualifications: A bachelor's degree in biomedical electronics; A bachelor's degree in engineering; a bachelor's degree in Medicine or Pharmacy, and a certificate in medical equipment training issued by legitimate training institutions or an equivalent certificate from abroad, with a minimum training period of one month;

For those who hold the aforementioned qualifications and have worked directly in medical equipment technology or management at legitimate healthcare facilities for three years or more, confirmed by their unit head, they are not required to have a certificate in medical equipment training;

- Must have a team of technical staff capable of meeting production requirements for the products manufactured by the business;

b) Technical infrastructure:

Must have appropriate floor space and production environment for the products manufactured by the business; must have sufficient production equipment and procedures; must have quality control equipment recognized by state metrology authorities that are suitable for the products manufactured by the business; must have fire prevention and explosion protection equipment, personal protective equipment, and ensure safety and environmental hygiene, labor hygiene according to legal regulations;

3.2. Scope of Practice:

Products manufactured by the business may only be circulated in the market after being registered for circulation by the Ministry of Health;

4. Conditions and scope of professional practice for individuals engaged in medical equipment trade, medical equipment agents:

4.1. Personnel and infrastructure conditions:

a) Personnel:

- The person responsible for technical matters must have one of the following qualifications: A bachelor's degree in engineering; A bachelor's degree in Medicine or Pharmacy; A diploma from one of the following schools: Technical Medical School, Technical Pharmacy School; A diploma from the Medical Equipment Engineering School;

- Technical staff with intermediate-level qualifications from other fields must have a certificate in medical equipment training issued by legitimate training institutions or an equivalent certificate from abroad; the training period for this course must be at least one month;

- Must have technical staff capable of guiding the use of medical equipment sold by the business.

b) Technical infrastructure:

There must be stores and warehouses that meet the conditions to properly store medical equipment; have all necessary technical tools for installation, warranty, maintenance of medical equipment; have all fire prevention and safety, environmental hygiene facilities.

4.2. Scope of Practice:

a) For individuals engaged in the business of medical equipment: Only allowed to trade in hospital furniture and medical supplies that have been granted import permits or registration certificates for circulation by the Ministry of Health.

b) For medical equipment agents: Only allowed to trade in medical equipment produced by their own enterprises.

VIII. CONDITIONS FOR PERSONS ENGAGED IN SPECIALIZED WORK AT MEDICAL AND TRADITIONAL MEDICINE PRACTICE ESTABLISHMENTS

ACTIVITIES AT HEALTH AND TRADITIONAL MEDICAL PRACTICE ESTABLISHMENTS

1. Private medical and traditional medicine practice establishments must have sufficient personnel qualified for the scope of practice. Persons engaged in specialized work at private medical practice establishments, as stipulated in this Circular, must:

a) Hold appropriate academic degrees or certificates attesting to professional qualifications for the assigned tasks;

b) Have full civil capacity;

c) Have a health certificate issued by a district-level or higher medical examination and treatment facility certifying their fitness to work;

d) Have a labor contract in accordance with the Labor Law;

đ) Not be currently prohibited from practicing or engaging in work related to healthcare pursuant to a court decision; not be under criminal investigation or administrative supervision; not be serving a prison sentence or administrative sanction involving placement in an educational institution, medical facility, or administrative supervision; not be serving disciplinary sanctions in the field of healthcare.

2. Foreign nationals engaged in specialized work at private medical and traditional medicine practice establishments must obtain a permit from the Provincial Department of Health (delegated by the Ministry of Health to provincial departments of health) if they comply with the provisions of Articles 21 and 22 of Decree No. 103/2003/NĐ-CP (whereby foreign-accredited or notarized certificates must be legalized and translated into Vietnamese, with the translation certified by a Vietnamese legal officer as prescribed by Vietnamese law. Legalization procedures are carried out in accordance with Circular No. 01/1999/TT-NG dated June 3, 1999 of the Ministry of Foreign Affairs on the rules for legalization of documents; foreign physicians must provide their full name in the original language, phonetic transcription, and additionally in Vietnamese for those from China).

The procedure for permitting foreign nationals to engage in specialized work at private medical and traditional medicine practice establishments is as follows:

a) Within thirty working days from the date of receipt of complete legal files, the Provincial Department of Health must organize an assessment of the professional qualifications of the foreign national and issue a permit;

b) In cases where a permit is not issued for a foreign national to engage in specialized work at a private medical or traditional medicine practice establishment, a written response must be provided stating the reasons;

c) The Provincial Department of Health shall organize advisory boards with the participation of the Provincial Medical Association and Traditional Medicine Association to review and submit recommendations to the Director of the Provincial Department of Health regarding the employment of foreign nationals in specialized work at private medical and traditional medicine practice establishments within their jurisdiction;

d) Private medical and traditional medicine practice establishments may only hire foreign nationals for specialized work in accordance with the number specified in Circular No. 04/2004/TT-BLDTBXH dated March 10, 2004 of the Ministry of Labor, Invalids, and Social Affairs guiding the implementation of certain provisions of Decree No. 105/2003/NĐ-CP dated September 17, 2003 of the Government on the recruitment and management of foreign workers in Vietnam, and Circular No. 24/2005/TT-BLDTBXH dated September 26, 2005 of the Ministry of Labor, Invalids, and Social Affairs amending and supplementing certain points of Circular No. 04/2004/TT-BLDTBXH dated March 10, 2004 of the Ministry of Labor, Invalids, and Social Affairs guiding the implementation of certain provisions of Decree No. 105/2003/NĐ-CP dated September 17, 2003 of the Government on the recruitment and management of foreign workers in Vietnam.

3. Permits issued to foreign nationals for specialized work at private medical and traditional medicine practice establishments will be revoked if such persons are ordered to be expelled or criminally processed by competent Vietnamese authorities.

4. When there is a change in personnel engaged in specialized work, private medical and traditional medicine practice establishments must report in writing to the issuing Provincial Department of Health for monitoring.

5. Personnel engaged in specialized work at private medical and traditional medicine establishments must wear name badges during working hours according to the model specified in Appendix 1 attached to this Circular.

6. In cases where the head of a private medical or traditional medicine practice establishment cannot directly manage the establishment due to illness, leave, study, or other reasons, the following regulations must be followed:

a) If the inability to directly manage the establishment lasts less than three days, a written authorization must be given to a person who meets the requirements set forth in Section III of this Circular;

b) If the inability to directly manage the establishment lasts more than three days, a written authorization must be given to a person who meets the requirements set forth in Section III of this Circular, and a written report must be submitted to the local Provincial Department of Health;

c) If the inability to directly manage the establishment lasts from thirty to one hundred eighty days, a written authorization must be given to another person, a written report must be submitted to the Provincial Department of Health, and approval in writing must be obtained from the Provincial Department of Health;

d) If the inability to directly manage the establishment lasts more than one hundred eighty days, the private medical practice establishment must apply for a professional practice certificate for the substitute head;

đ) Depending on the specific organizational form of the practice establishment, the person authorized to replace according to points a, b, c, and d of Clause 6 of this Section must meet the conditions stipulated in Section III of this Circular.

e) Encourage private medical and pharmaceutical practices to have two individuals with private medical practice licenses so that they can substitute for each other when necessary. In cases where a practice has two individuals with private medical practice licenses, if the licensed individual who is the head is absent, they may delegate authority to another person with a license and report this in writing to the local Department of Health.

IX. PROCEDURES, AUTHORITY TO ISSUE, EXTEND, REVOKE PRACTICE LICENSES AND CERTIFICATES OF ELIGIBILITY FOR PRACTICE, ISSUANCE OF PERMITS FOR FOREIGN PERSONS TO ENGAGE IN PROFESSIONAL ACTIVITIES, PERMISSION FOR ORGANIZATIONS TO CONDUCT CHARITABLE HEALTH CAMPAIGNS, AND VOLUNTEER SERVICE AT HEALTH FACILITIES BY INDIVIDUALS.

PROFESSION, CERTIFICATE OF ELIGIBILITY FOR PRACTICE, AND LICENSE ISSUANCE

OPERATIONS FOR FOREIGN PERSONS, PERMITTING THE ORGANIZATION OF HUMANITARIAN MEDICAL MISSIONS, VOLUNTEER SERVICES TO PATIENTS

AT MEDICAL FACILITIES

AT MEDICAL AND TREATMENT FACILITIES

1. Procedures, authority to issue, extend, and revoke practice licenses and certificates of eligibility for practice shall be carried out strictly in accordance with the provisions of Chapter III of the Private Medical and Pharmaceutical Practice Ordinance and Decree No. 103/2003/NĐ-CP. The application file must include two color passport-sized photographs measuring 4cm x 6cm.

a) In case of loss of a practice license, the individual who lost the license must submit a request for issuance of a new practice license.

The application for issuance of a new practice license, as stipulated in Clause 1 of this Section, must also include a certificate of loss of the practice license, confirmed by the police station of the district where the individual lost the license.

A new practice license issued must clearly state that it is the second or third issuance and its validity period will correspond to the remaining validity period of the previously lost license.

b) In case of loss of a certificate of eligibility for practice, the entity which lost the certificate must submit procedures to request issuance of a new certificate of eligibility for practice.

The application for issuance of a new certificate of eligibility for practice, as stipulated in Clause 1 of this Section, must also include a certificate of loss of the certificate of eligibility for practice, confirmed by the police station of the district where the entity lost the certificate.

A new certificate of eligibility for practice issued must clearly state that it is the second or third issuance and its validity period will correspond to the remaining validity period of the previously lost certificate.

2. The application files, procedures, and authority to issue permits for foreign persons to engage in professional activities at private medical and traditional medicine facilities are regulated as follows:

a) Documents:

- Professional qualifications and other documents specified in Point a, b, Clause 1, Article 21 of Decree No. 103/2003/NĐ-CP in the application file must be issued or certified by foreign authorities and must be legalized by consular authentication and translated into Vietnamese. The translation must be notarized according to Vietnamese law. Consular legalization is carried out in accordance with Circular No. 01/1999/TT-NG dated June 3, 1999, issued by the Ministry of Foreign Affairs on the rules for legalization of documents.

- Foreign physicians must fully record their name in the native language, phonetic script, and additionally in Vietnamese for Chinese physicians.

- Foreign individuals directly conducting examinations and treatments who do not fluently speak Vietnamese must have an interpreter meeting the requirements set forth in Article 22 of Decree No. 103/2003/NĐ-CP.

b) The permit for foreign persons to engage in professional activities at private medical and traditional medicine facilities shall have a term corresponding to the labor contract with the private medical and traditional medicine facility in Vietnam, but not exceeding five years.

c) If a foreign person wishes to extend the time for engaging in professional activities at a private medical or traditional medicine facility, they must submit the application file as stipulated in Point a of this Section to the Department of Health that issued the permit for extension or to the Department of Health where the health practice facility is located (in cases previously approved by the Ministry of Health).

3. The Ministry of Health delegates the Director of the Provincial Department of Health to issue practice licenses and certificates of eligibility for practice for clinics established under the Enterprise Law and clinics with foreign investment; to review and approve additional departments and specialized clinics of hospitals already holding certificates of eligibility for practice, except for new specialized techniques, and must report in writing to the Ministry of Health immediately after issuing the licenses and approving additional departments and specialized clinics of private hospitals. The scope of professional practice for the types of entities delegated in this Clause is promulgated together with the Decision of the Department of Health.

4. Application files, procedures, and authority to permit organizations to conduct charitable health campaigns.

a) Documents:

- List of personnel, application files of individuals engaged in professional work in the team (curriculum vitae, certified copies of professional qualifications);

- List of medical equipment, medical supplies, anti-shock kits;

- List of free medications;

- For foreign individuals engaged in professional work, a permit from the Department of Health is required.

b) Procedures and authority:

- The application file for charitable health campaigns must be submitted to the Provincial Department of Health where the campaign is organized for examination and approval;

- Within fifteen working days from the date of receipt of complete and valid application files, the Department of Health issues a decision permitting the organization of charitable health campaigns at public or private healthcare facilities. In cases of disagreement, a written response must be provided with specific reasons;

- Within fifteen days from the end of the charitable health campaign, a report on the activity results must be submitted to the Department of Health that issued the permission to organize the charitable health campaign.

5. The Ministry of Health establishes advisory councils with the participation of representatives from the Vietnam Medical Association and the Vietnam Traditional Medicine Association to examine and present to the Minister of Health for issuance or extension of private medical practice licenses within their authority.

The Department of Health establishes advisory councils with the participation of provincial medical associations and traditional medicine associations to examine and present to the Director of the Department of Health for issuance or extension of private medical practice licenses within their authority. In necessary cases, the Department of Health may invite additional relevant professional associations to participate in accordance with the scope of the practice license being examined.

6. In the case where a private traditional medicine establishment relocates its practice to another location within the same province or centrally governed city, it shall not be required to change its practice permit certificate. If the relocation is to another province or centrally governed city as stipulated in Clause 4, Article 39 of the Private Medical and Pharmaceutical Practice Ordinance, the holder of the practice permit certificate must return the original practice permit certificate and obtain confirmation from the Health Department of the place of departure, then submit the application dossier for issuance of a new practice permit certificate along with a certified copy of the practice permit certificate to the Health Department of the place where the practice facility is located.

7. The procedures for issuing and renewing practice permit certificates and certificates of qualification for practicing medicine and traditional medicine, and private medical equipment are prescribed as follows:

a) Pursuant to the authority of the Ministry of Health:

- Application dossiers for issuing and renewing practice permit certificates for private medical establishments shall be submitted to the Department of Treatment - Ministry of Health;

- Application dossiers for issuing and renewing practice permit certificates for private traditional medicine establishments shall be submitted to the Department of Traditional Medicine - Ministry of Health;

- Application dossiers for issuing and renewing certificates of qualification for practicing in private medical equipment manufacturing enterprises shall be submitted to the Department of Medical Equipment and Construction - Ministry of Health;

b) Pursuant to the authority of the Health Departments:

Application dossiers for requesting the Director of the Health Department to issue and renew practice permit certificates and certificates of qualification for practicing medicine, traditional medicine, and private medical equipment shall be submitted to the Health Department where the private medical or pharmaceutical establishment is headquartered.

8. The application dossier for renewing the Certificate of Qualification for Practicing Private Medicine includes:

a) A request for renewal of the Certificate of Qualification for Practicing;

b) A certified copy of the relevant practice permit certificate corresponding to the registered form of practice; a certified copy of the business registration certificate; a certified copy of the Certificate of Qualification for Practicing Medicine and Pharmacy;

c) An inventory of organizational personnel, specialized equipment, and technical facilities;

d) A report on operational activities over the past five years.

9. The procedure for reviewing applications for issuing and renewing practice permit certificates and certificates of qualification for practicing medicine, traditional medicine, and private medical equipment.

a) After receiving the application dossier for issuing and renewing practice permit certificates and certificates of qualification for practicing medicine, traditional medicine, and private medical equipment, the agency receiving the dossier shall send to the applicant or the establishment requesting issuance or renewal a receipt of the application dossier (in accordance with Form Appendix 2 issued together with this Circular);

b) Within fifteen working days from the date recorded on the receipt of the application dossier, if there is no request for supplementation, the Ministry of Health or the Health Department must organize an assessment to issue or renew the practice permit certificate and certificate of qualification for practicing; if not issued or renewed, they must provide a written response stating the reasons;

c) If the agency receiving the dossier finds that the application dossier for issuing or renewing the practice permit certificate and certificate of qualification for practicing is not valid, within ten working days from the date recorded on the receipt of the application dossier, the agency receiving the dossier must notify the applicant or the establishment requesting issuance or renewal to supplement or complete the dossier;

d) Upon receiving a request for supplementation, the applicant or the establishment requesting issuance or renewal must supplement according to the requirements and submit to the agency receiving the dossier. The date of receipt of the supplemented dossier is recorded in the incoming correspondence register of the agency receiving the dossier. Within fifteen working days from the date recorded on the receipt of the application dossier, if the agency receiving the dossier does not request supplementation, it must issue or renew the practice permit certificate and certificate of qualification for practicing; if not issued, it must provide a written response stating the reasons;

đ) In cases where the establishment requesting issuance or renewal of the practice permit certificate and certificate of qualification for practicing supplements the dossier but does not meet the requirements, the agency receiving the dossier will notify the establishment to continue supplementing or completing the dossier.

10. The assessment of conditions for medical, traditional medicine, and private medical equipment establishments must comply with the following procedures:

a) Establish an assessment team: The assessment team must include members from the management unit, legal department, members performing professional tasks suitable for the type of assessment of the private medical establishment, and other related members;

b) Conduct direct assessment at the establishment requesting assessment. The assessment work must ensure the following requirements:

- Inspect the conditions regarding organization, personnel, and conditions for those performing professional tasks at the establishment;

- Inspect the conditions regarding equipment and facilities in accordance with the provisions of this Circular, depending on the form of practice requested for assessment;

- Prepare an assessment record (in accordance with Form Appendix 3 issued together with this Circular). In the assessment record, the scope of practice and the list of emergency drugs of the establishment being assessed must be clearly stated based on the actual capacity of human resources, facilities, and equipment of the establishment;

- Within fifteen days from the date of assessment, the assessment team must submit the assessment record to the leadership of the Ministry of Health or the Health Department for consideration of issuing or not issuing the Certificate of Qualification for Practicing Private Medicine without the need to establish an assessment board.

11. The practice permit certificate and certificate of qualification for practicing are implemented according to the models prescribed in Appendices 4 and 5 issued together with this Circular.

12. Private medical, traditional medicine, and medical equipment establishments that have been granted certificates of qualification for practicing who wish to change their establishment name must submit a letter along with all relevant legal documents for the name change to the competent authority issuing the certificate of qualification for practicing after registering the change in the establishment's charter and operation regulations.

13. In the event of a change in the director of a hospital, the establishment must report to the competent authority issuing the certificate of qualification for practicing for management purposes.

X. IMPLEMENTATION PROVISIONS

1. This Circular takes effect fifteen days after its publication in the Official Gazette.

Repeal the provisions on private medical practice, traditional medicine practice, and private medical equipment specified in Circular No. 01/2004/TT-BYT dated January 6, 2004, guiding private medical and pharmaceutical practice; Circular No. 09/2004/TT-BYT dated September 14, 2004, amending and supplementing certain points of Circular No. 01/2004/TT-BYT dated January 6, 2004, issued by the Ministry of Health, guiding private medical and pharmaceutical practice; and Circular No. 07/2005/TT-BYT dated March 9, 2005, guiding amendments to Point 2, Clause 8, Article 79 of Circular No. 01/2004/TT-BYT dated January 6, 2004, issued by the Ministry of Health, guiding private medical and pharmaceutical practice.

2. Civil servants, public officials, and employees may engage in private medical and traditional medicine practice until December 31, 2010. Any private medical practice license or certificate of eligibility for private medical practice issued or renewed by civil servants, public officials, or employees leading such practices at any time shall cease to be valid on December 31, 2010.

3. New hospitals or those undergoing renovation that have not yet met the conditions stipulated in Point h, Item 1, and Paragraph 3, Point n, Subitem 1.1, Section V, and Point i, Subitem 1.1, Section VI of this Circular, and clinics lacking adequate floor space and height must develop a plan to address these deficiencies in accordance with the provisions of this Circular.

4. Optical service facilities existing prior to the effective date of Circular No. 01/2004/TT-BYT that meet the conditions regarding personnel engaged in specialized work and physical infrastructure, medical equipment as prescribed in Point d, Subitem 3, Section III of this Circular, and whose heads do not hold a diploma from a secondary vocational school in health care or higher but possess a training certificate in medical equipment issued by a facility designated by the Ministry of Health shall be subject to on-site inspection by the Department of Health. If they satisfy these conditions, these optical service facilities will be allowed to continue operations until December 31, 2008. By December 31, 2008, if any optical service facility fails to meet the head qualification requirements, it must cease operations.

5. Private medical and traditional medicine practices, and private medical equipment facilities licensed or certified by the Ministry of Health for eligibility to operate are subject to management, inspection, and oversight by the Department of Health and other competent authorities at the local level.

During implementation, if difficulties arise, units and localities must report them to the Ministry of Health (directly sent to the Departments of Treatment, Traditional Medicine, or Medical Equipment and Health Facilities for specialized issues, or submitted to the Legal Affairs Department for general issues related to the aforementioned Departments) for research and resolution./.