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The Vietnamese MOH Issues Draft Decree to Address Delays
Published on: December 15th, 2022
On November 15th, the Vietnamese Ministry of Health (MOH) issued a draft decree to address delays and amend/supplement a number of articles from their previous Decree No. 98/2021/ND-CP (the original document can be found here). While the draft decree will update several regulatory items, the most important are the use of third party(ies) to assist with the review of C/D applications, validity extension of Import Licenses, and the delay in implementing CSDT documentation.
Commonly known as Decree 98/2021, the decree governs medical device oversight in Vietnam and represents new, ASEAN MDD harmonized, regulations. Since its implementation on January 1, 2022, the Vietnamese MOH have issued a very limited number of new Market Authorization Licenses for Class C and D devices. This delay has caused frustration to not only manufacturers, but also local medical establishments that need new equipment.
Below are some of the highlights from the latest decree:
- Import licenses (issued from 2018 onward) will auto extend to December 31st, 2023 (clause 2, page 8)
- MOH will issue the list of medical devices that must declare their price beginning July 1, 2023. The License holder must declare the max selling price and there’s no need to declare importation costs, profit, other expenses, etc. (clause 10, page 5)
- Implementation of CSDT will be delayed until Jan 1, 2024 (clause 10, page 13)
- New registration process for class C/D medical devices will utilize third party(ies):
- All class C/D dossier are to be submitted to an independent evaluation unit (effective from Sep 1, 2023). Products will receive a confirmation letter once reviewed. (Article 30b of the draft decree).
- The dossier, as well as the confirmation letter will then be submitted to the MOH (effective from Jan 1, 2024, clause 9 page 13)
- New regulations to clarify the handling of medical devices should their registration number (MA License) be revoked. Per Article 38 Decree 98/2021: “After receiving a decision to revoke the free-sale registration number according to the cases specified in Article 38, medical facilities or users may continue to use the medical equipment until it is liquidated, in accordance with the law on management and use of public property or until the expiration of the product’s shelf life, except for medical equipment that cannot be remedied with defective elements that adversely affect the user’s health, as prescribed in Clause 4, Article 34 of this Decree 98/2021.” (clause 8, page 4)
- Medical device advertising update: the product owner’s name and the product’s origin must be added to ad content (clause 15, page 7)
For more information on the registration process in Vietnam, please see our Vietnam Medical Device Registration page.
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Please contact us if you need more information on medical device registration in Vietnam. Asia Actual has an office in Vietnam located in Ho Chi Minh City staffed by experienced, bilingual regulatory and commercial professionals that will address any questions or provide support.
Asia Actual is a regulatory consulting company specializing in helping manufacturers grow their sales through independent license holding, direct fulfillment, and a variety of sales channel support services.