Vietnam: MOH Releases Decree on Amendments and Supplements on Management of Medical Devices

On 3rd March 2023, the Vietnamese Ministry of Health (MOH) published Decree to complement the proposed decree on delays and amendments on the management of medical devices.

Previously, the implementation of Decree 98/2021 on January 2022 caused frustration issues among the manufacturer and medical facilities due to the limitation of Class C and Class D authorization licenses which later caused a disturbance in the market.

Hence, MOH released a decree draft on 15th November 2022 to alleviate delays and supplement/amend a number of articles from their prior Decree No. 98/2021/ND-CP. Later on 21st November 2022, MOH released an official announcement letter collecting comments regarding the decree draft issued.

Proposed Decree for Delays and Amendments Issued On 8 November 2022

There are three most crucial regulatory matters that being pointed out in the decree draft which are the employment of third party(ies) to assist with the evaluation of Class C or Class D medical device applications, the validity extension of import licenses and the delay in implementing the Common Submission Dossier Template (CSDT) paperwork.

Decree on Amending and Supplementing on Management of Medical Devices

MOH governs promulgating the amendment and supplementation of medical devices after revising comments received throughout the publicizing period of the decree draft between December 2022 to January 2023. Discussed below are the amendment and supplementation done regarding the three crucial regulatory matters.

1. For any individual or companies that produces and trades medical equipment must provide a price list as stated in Article 17 of Decree 177/2013 ND-CP. Based on MOH guidance, the price list should include the name or type of medical equipment, manufacturer’s country, calculation units and technical features of the equipment.

2. Content and procedure of price declaration must obey the provisions of the law and individuals or companies stated in Number 1 must declare the price list followed by Electronic Information Department of MOH.

3. MOH shall promulgate, update, amend and supplement the information guide list for any abnormal fluctuation that may affect the supply of medical equipment, buyer’s affordability and health insurance solvency.

4. Import licenses for medical equipment other than in vitro diagnostic products issued from 1ST January 2018 to 31st January 2021 may be continuously used until 31 December 2024.

5. While, for medical equipment that are in vitro diagnostic products, the import licenses registered starting from 1st January 2018 to 31st December 2021, also may continuously use until 31st December 2024 with no quantity limit.

6. Any medical equipment of Class C or Class D and unlisted, may continue importing without certification dossier and no quantity limitation until 31st December 2024.

7. For any medical equipment for in vitro diagnostic products that registered the circulation registration number from 1st January 2014 to 31st December 2019, may continue to use until 31st December 2024. While for domestic medical equipment production, any registration before 1st January 2022, the circulation registration certificate valid to be used until end of certificate period.

8. Compulsory application of Common Submission Dossier Template (CSDT) will have immediate effect on 1st January 2024.

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