Procedures for new issuance of marketing authorization numbers for Class-C or Class-D medical devices that have corresponding national technical regulations in Vietnam

Procedures for new issuance of marketing authorization numbers for Class-C or Class-D medical devices that have corresponding national technical regulations in Vietnam (Image from the internet)

On June 18, 2024, the Ministry of Health of Vietnam issued Decision 1705/QD-BYT regarding the announcement of administrative procedures in the field of Medical Devices amended and supplemented in Decree 96/2023/ND-CP.

Procedures for the issuance of a marketing authorization number for Class-C or Class-D medical devices that already have corresponding national technical regulations

Step 1: The organization applying for the marketing authorization number submits the application to the Ministry of Health of Vietnam through the Ministry of Health of Vietnam Administrative Procedure Resolution Information System (https://dichvucong.moh.gov.vn) or the Electronic Information Portal on medical device management (https://dmec.moh.gov.vn/).

Step 2:

- If the application falls under the priority cases as stipulated in Clause 21, Article 147 Decree 96/2023/ND-CP and the registrant submits a document requesting priority processing (including sufficient information about the file code submitted on the Ministry of Health's electronic portal; corresponding supporting documents for the priority cases), the Ministry of Health of Vietnam will consider and allow priority processing of the medical device circulation registration application within 10 working days from the date of receipt of the priority processing request and accompanying documents from the registrant.

If priority processing is not allowed, there must be a written response stating the reasons. If the application meets the priority criteria as stipulated, immediate priority assessment of the application will be conducted as per Step 3 and subsequent steps.

- If the application does not fall under the priority cases, proceed as stipulated in Step 3.

Step 3: If there are no requests for amendments or supplements to the circulation registration application, the Minister of Health is responsible for organizing the assessment to issue the marketing authorization number within 30 days from the date of receipt of a complete and valid application (including the documents confirming the payment of the assessment fee for the issuance of the circulation certificate as per the regulations of the Ministry of Finance). If no marketing authorization number is issued, there must be a written response stating the reasons.

Step 4: Upon receiving a request for supplementation or amendment of the marketing authorization number application application, the organization requesting the marketing authorization number must supplement or amend according to the notified contents and send it to the Ministry of Health of Vietnam.

If the organization requesting the marketing authorization number has supplemented or amended the application but it does not meet the requirements, the Ministry of Health of Vietnam will notify the organization to continue completing the application as per regulations.

After 90 days from the date of the Ministry of Health's notification requiring supplementation or amendment, if the organization does not supplement or amend the application, or if after 5 times of supplementation or amendment from the date of the first request for amendment, the application still doesn't meet the requirements, the procedure for applying for the marketing authorization number must be restarted.

Step 5: Within 1 working day from the date of issuance of the marketing authorization number, the Ministry of Health of Vietnam is responsible for publicizing the following information on the Electronic Information Portal on medical device management:

- Name, classification, manufacturer, country of manufacture of the medical device;- marketing authorization number of the medical device;- Name, address of the owner of the medical device;- Name, address of the holder of the marketing authorization number;- Name, address of the warranty center for the medical device;- Documents in the circulation registration application of the medical device, except for the common technical application on medical devices as per ASEAN regulations.

* Method of implementation:

- Submit the application online.

For the priority processing request for priority cases as stipulated in Clause 21, Article 147 Decree 96/2023/ND-CP where the registrant submits a document requesting priority processing (including sufficient information about the file code submitted on the Ministry of Health's electronic portal; corresponding supporting documents for the priority cases), this content can be submitted directly, via postal service, or online.

More details can be found in Decision 1705/QD-BYT effective June 18, 2024.

Nguyen Ngoc Que Anh

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