Circular No. 03/2001/TT-BYT guiding the business of medical equipment and devices

CIRCULAR

Guidelines for Medical Equipment and Devices Business

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Pursuant to Decree No. 11/1999/NĐ-CP dated March 3, 1999 of the Government on prohibited goods circulation and services, restricted business activities and conditional business activities, the Ministry of Health issues guidelines for medical equipment and devices business according to Item I, List 3 promulgated together with Decree No. 11/1999/NĐ-CP dated March 3, 1999 as follows:

Chapter 1:

GENERAL PROVISIONS

Article 1. Medical equipment and devices include all tools, technical equipment, specialized transportation means, consumable medical supplies used to serve preventive, diagnostic, and treatment activities in the healthcare sector.

Article 2. The business of medical equipment and devices is a type of conditional business activity.

Article 3. Business entities dealing in medical equipment and devices may only operate when they meet the conditions stipulated in this circular and are permitted to trade in medical equipment and devices that have been granted circulation permits by the Ministry of Health.

Chapter 2:

CONDITIONS FOR MEDICAL EQUIPMENT AND DEVICES BUSINESS

Article 4. Conditions for medical equipment and devices business for enterprises:

A. FOR ENTERPRISES ENGAGED IN PURCHASE AND SALE:

1. Regarding personnel:

a. The person primarily responsible for technical matters must hold a bachelor's degree in engineering or Medicine/Dentistry and possess certificates from one or more specialized training courses in medical equipment and devices issued by technical training institutions, or equivalent certificates issued abroad.

b. There must be a team of engineers and technical staff capable of guiding installation, warranty, and maintenance of the medical equipment and devices being traded.

c. The individuals mentioned above must be in good health and not currently under criminal investigation, serving a prison sentence, or having their professional license revoked by a court.

2. Regarding technical infrastructure:

a. There must be offices and warehouses suitable and capable of properly storing medical equipment and devices.

b. There must be sufficient technical tools and equipment to ensure the installation and warranty work can be carried out effectively.

c. There must be adequate fire prevention and firefighting equipment and ensure environmental hygiene and safety.

3. Regarding goods:

Enterprises may trade in medical equipment and devices that have been granted circulation permits by the Ministry of Health.

B. FOR ENTERPRISES WITH PRODUCTION:

1. Regarding personnel:

a. The person primarily responsible for technical matters must hold a bachelor's degree in engineering or Medicine/Dentistry and possess certificates from one or more specialized training courses in medical equipment and devices issued by technical training institutions, or equivalent certificates issued abroad.

b. There must be a team of technical staff and workers capable of meeting production requirements for the products manufactured by the enterprise.

c. The individuals mentioned above must be in good health and not currently under criminal investigation, serving a prison sentence, or having their professional license revoked by a court.

2. Regarding technical infrastructure:

a. There must be production floor space appropriate for the products manufactured by the enterprise.

b. There must be sufficient production equipment and quality control equipment suitable for the products manufactured by the enterprise.

c. There must be adequate fire prevention and firefighting equipment, personal protective equipment, and ensure environmental hygiene and safety.

3. Regarding goods:

Products produced by the enterprise may only be circulated in the market after obtaining circulation permits from the Ministry of Health.

Article 5. Conditions for medical equipment and devices business for individual traders:

1. Regarding personnel:

a. The person primarily responsible for technical matters must hold a high school diploma from Technical Medical High School, Technical Pharmacy High School, or a Technical Equipment Technician School. Technical staff with secondary education from other fields must possess certificates from one or more specialized training courses in medical equipment and devices issued by technical training institutions, or equivalent certificates issued abroad.

b. They must be in good health and not currently under criminal investigation, serving a prison sentence, or having their professional license revoked by a court.

2. Regarding technical infrastructure:

a. There must be stores and warehouses suitable and capable of properly storing medical equipment and devices.

b. There must be sufficient technical tools necessary for maintenance and repair of medical equipment and devices.

c. There must be adequate fire prevention and firefighting equipment and ensure environmental hygiene and safety.

3. Regarding goods:

Individual traders may only trade in hospital furniture, consumable medical supplies that have been granted circulation permits by the Ministry of Health.

Chapter 3:

AUTHORITY AND PROCEDURES FOR ISSUING CERTIFICATES OF MEETING BUSINESS CONDITIONS FOR MEDICAL EQUIPMENT AND DEVICES

Article 6. Authority for issuing certificates of meeting business conditions for medical equipment and devices:

The Department of Health of provinces and centrally governed cities (hereinafter referred to as provinces) is the authority responsible for assessing and issuing certificates of meeting business conditions for medical equipment and devices.

Article 7. Application dossier for issuing certificates of meeting business conditions for medical equipment and devices for enterprises:

1. Application form for issuing certificates of meeting business conditions for medical equipment and devices (Form 1).

2. Certificate of business registration (certified true copy).

3. Dossier of the person primarily responsible for technical matters of the enterprise.

4. Dossier of technical staff involved in installation and warranty work.

5. Documentation on organizational structure, warehouses, and technical equipment.

Article 8. Application dossier for issuing certificates of meeting business conditions for medical equipment and devices for individuals and individual traders:

1. Application form for issuing certificates of meeting business conditions for medical equipment and devices (Form 2).

2. Certificate of business registration (certified true copy).

3. Dossier of the person primarily responsible for technical matters of medical equipment and devices.

4. Documentation on warehouses and technical equipment.

Article 9. Within fifteen working days from the date of receipt of complete and valid dossiers, the Department of Health of the province will issue certificates of meeting business conditions for medical equipment and devices based on the results of the assessment of the business conditions stipulated in this circular. If a certificate is not issued, the reasons must be stated in writing.

Article 10. Enterprises granted certificates of meeting business conditions for medical equipment and devices must pay a fee as prescribed by current laws on fees and charges.

Chapter 4:

INSPECTION, AUDIT AND VIOLATION HANDLING

Article 11. Inspection and Audit

1. The Medical Equipment and Device Department shall coordinate with relevant Departments and the Ministry of Health Inspectorate to organize inspections and audits of the implementation of laws and regulations on medical equipment and devices and the provisions of this circular throughout the country.

2. The Provincial Health Department organizes inspections and audits of the implementation of legal provisions on medical equipment and devices and the provisions of this Circular within its jurisdictional area.

3. Inspections and audits shall be conducted regularly or at random.

4. Business establishments dealing with medical equipment and devices must comply and facilitate inspections and audits at their premises.

Article 12. Handling Violations:

The owner of a business establishment dealing with medical equipment and devices who violates the provisions of this Circular and related legal regulations shall be subject to administrative penalties, or criminal liability may be pursued if the violation is serious, and if damage is caused, compensation for such damage must be provided in accordance with the law.

Chapter 5:

IMPLEMENTING PROVISIONS

Article 13. This Circular takes effect fifteen days from the date of signature and replaces Circular No. 14/1998/TT-BYT dated November 17, 1998, guiding private medical equipment business activities.

During implementation, any difficulties or obstacles should be reported by units and localities to the Ministry of Health (Department of Medical Equipment - CTYT) for review and resolution.