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HOW TO EXTEND THE CIRCULATION NUMBER OF MEDICAL EQUIPMENT?

If locally produced medical equipment is to be sold in the Vietnamese market, it must comply with the requirements on registration numbers for free medical equipment sales. If a competent agency within the Ministry of Health has issued a product registration number to medical equipment, the validity period of the product registration number must be considered.

Legal basis:

- Law on Investment 2020;

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

1. Dossier for circulation registration number extension

- A written request for a circulation number extension;

- A copy of the certificate of circulation registration has been issued;

- For cases where a free-sale registration number has been granted but the free-sale number is not stated in the application dossier at the time of issuance, general technical dossiers follow the instructions in the ASEAN Agreement on medical equipment. ASEAN common technical papers are required for the issuance of circulation numbers;

- Authorization letter from the owner of the medical equipment for the establishment to carry out the circulation registration;

- Certificate of free sale for imported medical equipment is still valid at the time of application submission;

- Certificate of free sale for imported medical equipment is still valid at the time of application submission;

- Report on business outcomes within the time frame allotted for the circulation number to be issued.

2. Requirements for submitting an application for a circulation registration number extension

- The application for an extension of the free-sale registration number must be submitted at least 60 days before the circulation number expires.

- The documents in the application for an extension of the free-sale registration number of medical equipment are clearly printed and ordered in sequence; there is a separator between documents, a cover page, and a list of documents.

- Submit the original or a certified true copy or a copy certified by the applicant for the free-sale registration number for the Certificate of Meeting Quality Management Standards.

The Certificate of Satisfaction with Quality Management Standards must be translated into Vietnamese if it is not written in English or Vietnamese. A certified translation is required.

- For the owner of the medical equipment's power of attorney:

+ For medical equipment made in the United States, submit the original or a certified accurate copy;

+ Submit the consularly legalized copy or a certified copy of the consularly legalized copy for imported medical equipment.

- Submit the consularly legalized copy or a certified copy of the consularly legalized copy for the certificate of free sale.

+ The certificate of free sale must be translated into Vietnamese if it is not in English or Vietnamese. The translation must be validated in accordance with the legislation.

+ If the free sale certificate does not mention an expiration date, the certificate will be valid for 36 months from the date of issue.

3. Acceptance and evaluation of dossiers requesting free-sale registration numbers for medical equipment

- A dossier must be submitted to the Ministry of Health by the business requesting the issuing of a free-sale registration number.

- 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.

- The Minister of Health is responsible for: equipment if there is no request to revise or supplement the application for registration of circulation.

+ Organize the assessment to prolong the free-sale number within 30 days of the date printed on the application receipt for medical equipment without corresponding national technical regulations. If the circulation number is not renewed, a written response must be sent, clearly describing the reason;

- If the free-sale registration number application dossier is incomplete, the Ministry of Health must send a written notification to the establishment asking an extension of the free-sale registration number to complete or amend the dossier, stating the following: whose documents and contents must be changed within 15 working days of the application's receipt date.

The above information is about the “ How to extend the circulation number of medical equipment? ". For more information and advice on this issue, please contact Doanh Tri Law Firm directly via:

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