Medical Equipment Circulation Notification

Medical equipment utilised in the medical sector has a direct effect on health, people’s life. Therefore, enterprises need to register to circulate medical equipment in compliance with the law to ensure smooth utilisation.

What is medical equipment?

Medical equipment shall be defined as equipment, implant medical devices, tools, devices, reagent and In vitro diagnostic medical device, software’s response to the owner request to support medical demands.

Circulation book of Medical Equipments:

1. Is a book that record application criteria apply for medical equipment’s type A,B;
2. Is a book that record application criteria apply for medical equipment’s type C,D;
3. The circulation book has no expiry date. However, for the emergency book that issues on special occasions issued by the Minister of the Department of Health will have a special expiry date.

Legal documents relevant to medical equipment circulations:

1. Decision 98/2021/NĐ-CP about medical equipment’s management
2. Circular 19/2021/TT-BYT regulation of document sample, report to respond to Decision 98/2021/NĐ-CP about medical equipment’s managements
3. Circular 10/2023/TT-BYT amend Circular 19/2021/TT-BYT
4. Circular 05/2022/TT-BYT orient Decision 98/2021/NĐ-CP about medical equipment’s management.

Condition for circulating medical equipment’s:

1. Have circulation note/import document as per regulation.
2. Have complete stamps follow current regulation.
3. Have Vietnamese instruction.
4. Have warranty information such as condition, times.

(Instruction and Warranty information can be provided in the form of electronic information but it need to demonstrate clear instruction how to search for information on the equipment’s stamps)

Condition for granting for medical equipment’s circulation certificate:

1. For medical equipment’s produced domestically: Produce at the production site that has notifies all production condition
2. For imported medical equipment: Produces at the production sites that have granted ISO 13485 quality assurance and can be applied in other countries in the world.
3. Suitable with the antinational/production site technical criteria that has been notified.

However, enterprises should notice that competent authority can refuse circulation registration within 12 months, accounting from the date of 03 batches of the medical device are recalled during the validity of the registration number, except registration number holder’s voluntary recall of the medical device.

Medical Equipment type A,B quality self-declaration:

1. Document notify quality declaration
2. ISO 13485 quality assurance valid at the time submitting the documents.
3. Medical equipment’s owner authorization documents to the company that the quality assurances named under
4. Documents prove eligible warranty condition
5. Documents describe medical equipment in Vietnamese, attached with technical documents describing function, technical number of the medical equipment issued by the medical equipment owner. For reagent and in vitro diagnostic medical device, Standard substances then a technical document in Vietnamese is requested with technical documents in Vietnamese attached with documents about materials, product safety, production process, clinical and preclinical reports, stability reports.
6. Standard certificate as per regulation or product standard issued by owners.
7. For in vitro diagnostic medical devices produced domestically then chemist, physic, biology parameters and other parameters.
8. Documents instruct how to use medical equipment’s
9. Stamp sample will be circulated in Vietnamese of medical equipment’s
10. Certificate of free sale that is still valid at the time of submitting documents for imported medical equipment.

Medical Equipment type C, D quality self-declaration

1. Documents requesting new circulation number
2. ISO 13485 quality assurance documents
3. Authorization documents issued by medical equipment’s owner to the agency conducting the circulation
4. Documents prove eligibility in warranty issued by medical equipment’s owners
5. Valid circulation documents at the time submitting documents for imported medical equipment’s
6. General technical documents about medical equipment’s as regulated by ASEAN (short forms named as CSDT)
7. Standard certificate

Besides, depending on the situations (quick issue, emergency issue, medical equipment is the method to measure…) there will be changes in the application.

Document submitting procedure:

1. Product – self declaration procedures: Submit the application to Health Department where business headquarter located
2. For medical equipment circulation registration procedures: Submit the application to the Health Department through an electric portal about medical equipment managemen

Should you have any questions, please don’t hesitate to contact An Luat Vietnam for consultation, support. Our law firm with experienced lawyers, always available to support enterprises in completing the application as well as necessary procedures to circulate medical equipment. Our firm will guarantee legal safety and lawful benefit to clients’ activities.