Circular No. 278/2016/TT-BTC promulgates the table of fee levels in the healthcare sector including types of fees such as assessment for issuing permits, import, export of medical equipment; assessment of business conditions and professional standards. The fee level ranges from 150 thousand VND to 10,500 thousand VND depending on each type of service.
Đối tượng áp dụng
Organizations and individuals related to the healthcare sector when implementing procedures for permit issuance, import, export of medical equipment; business and practice of healthcare.
Các điểm cốt lõi
- Assessment fee for issuing circulation permits, standard announcement application for medical equipment ranges from 1,000 to 5,000 thousand VND depending on the type.
- Assessment fee for issuing import permits for medical equipment is 2,000 thousand VND.
- Assessment fee for business conditions within the medical equipment sector is 3,000 thousand VND.
- Assessment fee for activities, professional standards ranges from 150 to 10,500 thousand VND depending on the type of service.
- thoigianhieuungdung
🌐 Tác động xã hội từ văn bản này
- Strengthening quality management of medical equipment to ensure safety for users.
- Encouraging organizations and individuals to comply with legal regulations in healthcare business and practice activities.
❓ Câu hỏi thường gặp
What is the assessment fee for issuing import permits for medical equipment?
The assessment fee for issuing import permits for medical equipment is 2,000 thousand VND.
What types of fees are specified in this Circular in the healthcare sector?
This Circular stipulates types of fees such as assessment for issuing permits, import, export of medical equipment; assessment of business conditions and professional standards.
Toàn văn
|
MINISTRY OF FINANCE |
SOCIALIST REPUBLIC OF VIET NAM |
|
Number: 278/2016/TT-BTC |
Hanoi, November 14, 2016 |
CIRCULAR
REGULATIONS ON THE LEVEL OF COLLECTION, COLLECTION SYSTEM, PAYMENT, MANAGEMENT AND USE OF FEES IN THE HEALTH SECTOR
Pursuant to the Law on Fees and Registration Fees dated November 25, 2015;
Pursuant to the State Budget Law dated June 25, 2015;
Pursuant to Decree No. 120/2016/NĐ-CP dated August 23, 2016, issued by the Government, detailing and guiding the implementation of certain Articles of the Law on Fees and Registration Fees;
Pursuant to Decree No. 215/2013/NĐ-CP dated December 23, 2013, promulgated by the Government stipulating the functions, tasks, powers, and organizational structure of the Ministry of Finance;
At the proposal of the Director of the Department of Tax Policy,
The Minister of Finance hereby issues this Circular regulating the level of collection, collection system, payment, management and use of fees in the healthcare sector.
Article 1. Scope of Regulation, Applicability
1. This Circular stipulatesto regulate the level of collection, collection system, payment, management and use of fees in the health sector.
1. The payer of the fee is an individual who requests the competent authority to issue or reissue a production confirmation certificate in accordance with Circular No. 41/2015/TT-BTNMT dated September 9, 2015 of the Minister of Natural Resources and Environment regarding the production confirmation certificate and any subsequent amendments, supplements, or replacements thereof (if any).applicable to those who pay, organizations collecting fees in the health sector and other organizations and individuals related to the collection, payment, management and use of fees in the health sector.
Article 2. Persons Paying Fees
TOrganizations and individuals when requesting state management agencies to perform tasks related to the health sector as specified in the Fee Schedule attached hereto must pay the fee.
Article 3. Fee Collection Organizations
Collection organizationsincluding the Ministry of Health, the Ministry of National Defense; Provincial Departments of Health under central cities implementing work subject to fees as stipulated in this Circular are collection organizations.
Article 4. Fee Rates
Briefly describe technical improvements, production processes, raw materials, designs; new technology applications such as automation, digitalization, clean technology; management, marketing, distribution solutions; products winning awards or certifications related to innovation…):…The level of fee collection in the health sector shall be implemented according to the provisions of the Fee Schedule attached to this Circular.
Article 5. Declaration and Payment of Fees
1. ChuAt the latest on the 5th day of each month, the collection organization must deposit the amount of fees collected from the previous month into the fee account awaiting submission to the State Treasury.
2. Collection organizations shall declare and pay the amount of fees collected monthly, settle accounts annually in accordance with the guidance provided for in Clause 3 Article 19, Clause 2 Article 26 of Circular No. 156/2013/TT-BTC dated November 6, 2013 issued by the Minister of Finance guiding the implementation of certain Articles of the Law on Tax Administration; the Law amending and supplementing certain Articles of the Law on Tax Administration and Decree No. 83/2013/NĐ-CP dated July 22, 2013 of the Government.
Article 6. Management and Use of Fees
1.Collection organizations that are agencies under the Ministry of National Defense may retain 80% of the amount of fees collected to cover costs for the contents of expenditure as prescribed in Clause 2 Article 5 of Decree No. 120/2016/NĐ-CP dated August 23, 2016 of the Government. Pay 20% of the amount of fees collected into the State budget according to chapters and sub-items of the State Budget Classification currently in force.
2. OAs for collection organizations that are agencies under the Ministry of Health; Provincial Departments of Health under central cities:
a) ICollection organizations shall deposit the entire amount of fees collected into the State budget except in cases prescribed in point b Clause 2 of this Article. The cost of expenses for performing tasks and collecting fees shall be covered by the State budget in the organizational budget according to the State budget expenditure standards and norms.
b) InCases where the collection organization is a state agency allocated costs for operations from fee revenue as prescribed in Clause 1 Article 4 of Decree No. 120/2016/NĐ-CP dated August 23, 2016 of the Government, may retain 80% of the amount of fees collected to cover costs for the contents of expenditure as prescribed in Article 5 of Decree No. 120/2016/NĐ-CP dated August 23, 2016 of the Government. Pay 20% of the amount of fees collected into the State budget according to chapters and sub-items of the State Budget Classification currently in force.
Article 7. Implementation Organization
1. This Circular takeseffect from January 1, 2017 and replaces Circular No. 03/2013/TT-BTC dated January 8, 2013 issued by the Minister of Finance regulating fees for business registration approval with conditions; approval of professional standards and conditions; license issuance fees for medical equipment, pharmaceuticals, practice certificates, and operation permits for medical facilities.
2. Othermatters related to the collection, payment, management, use, receipt vouchers, and publicizing the collection system not mentioned in this Circular shall be implemented in accordance with the Law on Fees and Charges, Decree No. 120/2016/NĐ-CP dated August 23, 2016 of the Government; Circular No. 156/2013/TT-BTC dated November 6, 2013 issued by the Minister of Finance; Circular of the Minister of Finance on printing, issuing, managing, and using various types of fee and charge receipts belonging to the State budget and any amendments, supplements, or replacements (if any).
3. During theimplementation process, if there are any difficulties, organizations and individuals are requested to promptly report to the Ministry of Finance for research and supplementary guidance.
|
Place ofReceipt: |
Deputy DirectorPRIME MINISTER |
dated November 14, 2016
(Issued together with Circularof the Minister of Finance Name of Fee,Calculation Basis
|
Quarter (1) |
(VND 1,000)Pursuant to Decree No. 120/2016/NĐ-CP dated August 23, 2016 of the Government detailing and guiding the implementation of certain provisions of the Law on Fees and Charges |
Unit of ChargeApproval of a permit for chemical substance testing, insecticide, bactericide products for household and healthcare use |
Briefly describe technical improvements, production processes, raw materials, designs; new technology applications such as automation, digitalization, clean technology; management, marketing, distribution solutions; products winning awards or certifications related to innovation…):…Collection Rate Approval of application dossier for registration certificate of circulation of chemical substances, insecticides, bactericides for household and healthcare useNew approval |
|
I |
Fees for examination and approval of acceptance, import, export, confirmation in the field of insecticides, bactericides for household and medical use |
|
|
|
1 |
THEChange of name approval |
Hfiles |
2.000 |
|
2 |
THEExtension approval |
|
|
|
a |
THEApplication dossier |
Hfiles |
8.000 |
|
b |
THEAdditional registration approval for the following cases: |
Hfiles |
5.000 |
|
specialized agency under the People's Committee of the province/city. |
THEChange of name, address of the production unit, registration unit; change of ownership of the registration certificate; reissue of the registration certificate; |
Change of production location, production facility and changes in function, quality criteria or usage method |
1.000 |
|
For coal-fired thermal power plants where the enterprise holds 100% of the registered capital and uses 100% of its own capital to invest in the project approved by the competent authority, E is determined as 100%; |
THEApproval of confirmation of advertising content of chemical substances, insecticides, bactericides for household and healthcare use |
LChapter |
|
|
|
Approval of free circulation certificate for chemical substances, insecticides, bactericides for household and healthcare useApproval of import permit for insecticides, bactericides for household and healthcare use |
|
1.000 |
|
|
Approval of free circulation certificate for chemical substances, insecticides, bactericides for household and healthcare useSufficient Conditions for Production, Testing, Inspection, and Pest Control Services |
|
2.000 |
|
3 |
THEApproval Fee for Medical Device Circulation, Import, Export, and Announcement |
Hfiles |
1.000 |
|
4 |
THEApproval of registration certificate for medical device standards/applicable medical devices/in vitro diagnostic medical devices |
LChapter |
2.000 |
|
5 |
THENew approval: |
Hfiles |
2.000 |
|
6 |
Class AClass B |
Hfiles |
300 |
|
II |
Class C, D |
|
|
|
1 |
THEExtension approval |
|
|
|
a |
THEReissue approval |
|
|
|
|
LoImport permit approval for medical devices |
Hfiles |
1.000 |
|
|
LoExport permit approval for medical devices |
Hfiles |
3.000 |
|
|
LoApproval Fee for Business Conditions in the Medical Device Sector |
Hfiles |
5.000 |
|
b |
THEApproval Fee for Activities, Standards, and Practice Conditions in the Healthcare Sector |
Hfiles |
2.000 |
|
specialized agency under the People's Committee of the province/city. |
THEApproval and reissue of operating permits as prescribed in |
Hfiles |
1.000 |
|
2 |
THEClause 1 Article 48 of the Law on Medical Examination and Treatment; when changing the form of organization, splitting, merging, or consolidating medical examination and treatment facilities; issuing operating permits when changing locations for medical examination and treatment facilities; issuing operating permits when changing department scale, number of beds, organizational structure: |
Hfiles |
2.000 |
|
3 |
THEHospital |
Hfiles |
1.000 |
|
III |
Fees for assessing business conditions in the medical equipment sector |
Hfiles |
3.000 |
|
IV |
Fees for assessing activities, standards, and practice conditions in the healthcare sector |
|
|
|
1 |
Assessment for issuing or reissuing an operating permit due to revocation as stipulated in Clause 1, Article 48 of the Law on Medical Examination and Treatment; when changing organizational forms, splitting, merging, or consolidating medical examination and treatment facilities; issuing an operating permit when changing location for medical examination and treatment facilities; issuing an operating permit when changing the scale of departments, hospital beds, and organizational structure: Hospital |
LChapter |
|
|
|
BAssessment for issuing, reissuing, or adjusting a practicing certificate for medical examination and treatment for individuals whose certificates have been revoked according to Clause 1, Article 29 of the Law on Medical Examination and Treatment |
|
10.500 |
|
|
Outpatient clinics, maternity houses, infirmaries under the People's Public Security force, family medicine clinics (or clinics operating on the principles of family medicine).Specialized outpatient clinics. |
|
5.700 |
|
|
Outpatient clinics, consultation and preventive treatment. Occupational disease outpatient clinics.Diagnostic imaging rooms, X-ray rooms. Laboratory testing. Health service facilities. Other forms of organization for diagnosis and treatment.Traditional medical treatment. Rural health stations, dispensaries, and equivalent facilities.Re-evaluation to grant permits for healthcare intervention facilities to change gender. Reissue licenses for healthcare facilities due to loss, damage, or revocation as stipulated in point a, Clause 1, Article 48 of the Law on Diagnosis and Treatment; reissue licenses when changing the name of the healthcare facility; changing the person responsible for professional technical matters at the healthcare facility.Evaluation of healthcare facilities when changing the scope of professional activities, adding a list of professional technical services. Evaluation for issuing, reissuing, and adjusting practice certificates for diagnosis and treatment for individuals whose certificates have been revoked according to Clause 1, Article 29 of the Law on Diagnosis and Treatment.Reevaluation for reissuing practice certificates for diagnosis and treatment in cases of loss, damage, and revocation as stipulated in point a, b, Clause 1, Article 29 of the Law on Diagnosis and Treatment. |
|
4.300 |
|
|
Other forms of organization for diagnosis and treatment.Evaluation for issuing certificates of traditional medicine practitioners. TREvaluation for issuing certificates of traditional herbal formulas or traditional healing methods. |
|
3.100 |
|
2 |
THEFee for evaluation to issue certificates for biosafety laboratories. |
LChapter |
10.500 |
|
3 |
THEFor biosafety level 1 and 2 laboratories. |
LChapter |
1.500 |
|
4 |
For biosafety level 3 and 4 laboratories. |
LChapter |
4.300 |
|
5 |
THEAssessment of the content of film scripts, programs on tapes, discs, software, and other materials and documents in advertising medical examination and treatment services |
LChapter |
360 |
|
6 |
THEAssessment for reissuing a practicing certificate for medical examination and treatment for cases where the certificate is lost, damaged, or revoked according to point a, b, Clause 1, Article 29 of the Law on Medical Examination and Treatment |
LChapter |
1.000 |
|
7 |
THEAssessment for issuing a certificate of traditional medicine practitioner |
LChapter |
150 |
|
8 |
THEAssessment for issuing a certificate of traditional herbal prescription or traditional healing method |
LChapter |
2.500 |
|
9 |
THEFees for assessing the issuance of a certificate for a biosafety laboratory |
LChapter |
2.500 |
|
V |
For biosafety laboratories at level 1, 2 |
|
|
|
1 |
3. Amend Clause 3 Article 2 as follows:For biosafety laboratories at level 3, 4 |
LChapter |
4.500 |
|
2 |
3. Amend Clause 3 Article 2 as follows:đối với phòng xét nghiệm an toàn sinh học cấp 3, 4 |
LChapter |
9.000 |
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