PROCEDURES FOR ISSUING NEW REGISTRATION NUMBER OF FREE SALE OF MEDICAL EQUIPMENT DO NOT YET HAVE RELEVANT NATIONAL TECHNICAL REGULATIONS

Without appropriate national technical regulations, how is the application file for a new free-sale registration number for medical equipment B, C, and D handled? Which document specifically indicates this?

Legal basis:

- Law on Investment 2020;

- Decree 36/2016/ND-CP on medical equipment management.   

1. Dossier for a new free-sale registration number for medical equipment that does not comply with national technical regulations:

- A request for a new circulation number in writing;

- Medical equipment classification;

- At the time of application submission, the certificate of quality management standard is still valid;

- At the time of application submission, the owner of the medical equipment's power of attorney for the registration establishment is still valid;

- A certificate of eligibility for warranty from the owner of the medical equipment, unless the medical equipment is single-use as the owner of the medical equipment specifies or provides documentation confirming it is not. There is a warranty policy in place;

- At the time of application for imported medical equipment, the certificate of free sale is still valid;

- A brief technical description of the medical equipment in English, accompanied by a technical document outlining the medical equipment's operations and technical parameters, provided by the medical equipment's owner;

Reagents, calibrators, and in vitro control materials, in particular: Technical documents in Vietnamese, including documents on materials, product safety, manufacturing processes, clinical and preclinical research results, and stability reports;

- General technical documents adhere to the ASEAN Agreement on Medical Equipment's guidelines;

- Documentation for medical equipment use;

- Category C and D medical equipment that penetrates the human body: Except in the following circumstances, a summary of clinical trial data is included with clinical trial research results:

+ Medical equipment has been circulated and received a certificate of free sale from one of the following countries: EU member states, Japan, Canada, Australia (TGA), and the United States of America (FDA).

+ Medical equipment has been issued for circulation prior to the implementation of this Decree;

+ Any other instances that the Minister of Health deems necessary.

- A sample label to be used when medical equipment is circulated in Vietnam;

- Receipt of an application for a declaration of eligibility for manufacturing of domestically produced medical equipment in accordance with the product applying for a circulation registration number;

- Report on business results within the time limit for receiving a free-sale registration number connected to this Decree for medical equipment issued for free sale before the Decree's effective date and is exempt from submitting summary reports. Disable clinical trial data or revoke the certificate of accreditation.

2. Procedures for obtaining a free-sale registration number for medical equipment

- An application for a free-sale registration number for medical equipment must be submitted to the Ministry of Health.

- The Ministry of Health will issue a registration number requesting establishment receipt of a dossier of application for a free-sale registration number of medical equipment upon receipt of a complete and valid application.

- If no request to amend or supplement the application for circulation registration is received, the Minister of Health must: Organize the appraisal to issue a new free-sale registration number within 60 days or extend the free-sale registration number within 60 days within 30 days from the date written on the application receipt. If a circulation number is refused to be issued or renewed, the cause must be stated explicitly in writing.

- If the application for a free-sale registration number is incomplete, the Ministry of Health must send the applicant for a new free-sale registration number a written notice to supplement or amend the dossier, stating which documents and contents must be supplemented within 15 working days from the date indicated on the application receipt.

- If a business asking for a free-sale registration number has added or amended its dossier, but it does not meet the standards, the Ministry of Health will notify the establishment to complete it.

If the business does not supplement or change the dossier within 60 days of receiving the Ministry of Health's written request, it must continue the process of applying for a free-sale registration number from the beginning.

The above information is about the " Procedures for issuing new registration number of free sale of medical equipment do not yet have relevant national technical regulations". For more information and advice on this issue, please contact Doanh Tri Law Firm directly via:

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