“While the seminar provides some hope for manufacturers with pending Class C and D MA License applications, we won’t know if the new processes are actually put into place until at least October.”

David Vo
General Manager
Asia Actual Vietnam

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Vietnam’s DMEC Provides Update on Issuance of Class C and D MA Licenses

Published on: September 14th, 2022

Extends Existing Import License Validity and CSDT Grace Period

On September 14, 2022, the Department of Medical Equipment and Construction (DMEC) of the Ministry of Health (MOH) held a seminar to update the medical device industry on the issuance of Class C and D MA Licenses. The seminar comes 9 months into the new Vietnamese regulations outlined in Decree 98/2021 and no Class C or D Market Authorization (MA) Licenses have been issued. At the seminar the DMEC announced several steps they plan to implement in order to expedite the review of Class C and D MA applications and clear the backlog of pending applications. Not only has the delay in issuance of C and D MA Licenses frustrated medical device manufacturers, it has also created issues within the Vietnamese healthcare system as hospitals

Primary updates include:

  • Import Licenses are being automatically exteneded 1 more year to the end of 2023
  • CSDT documentation requirements are also being delayed 1 more year to January 1, 2024
  • The approval process is being updated. If the new process is applied in September 2022, DMEC expects that they will issue MA licenses to clear out the backlog of C and D applications. More information on the implementation is expected in October.
    • MA License review process for Class C and D Licenses
      • Step 1: 2 legal experts appraise the dossier; (according to new proposed process, this step will become a post-market activity)
      • Step 2: The reviewer summarizes the appraisal content;
      • Step 3: Submit to the Advisory Council for consideration;
      • Step 4: Ministry leaders sign and release.
  • 1 product can be have both, a valid Import License & a MA license in 2023, both license can be used in parallel.
  • Decree 98/2021, Circular 19/2021, Circular 14/2020 will be amended & modified in the coming months to reflect these changes

Overview of New Medical Device Requirements in Vietnam

The Vietnamese MOH implemented new requirements for medical devices on January 1, 2022 in accordance with Decree 98/2021. While it provided immediate registration for Class A and B products, Class C and D applications have been marred with delays due to internal interruptions at the MOH and have not been issued as of September 2022.

Some of the main highlights from the new requirements include:

  1. All Class B devices (not covered by a valid Import License) must have a MA License to be imported from Jan 1, 2022. (Note: Class A devices have required an MA License since Jan 1, 2020.) Class A and B MA Licenses are issued within 1 week of application submission.
  2. Class C and D devices (not covered by a valid Import License) that are listed in Circular 30/2015 (link to list here), must have a MA License to be imported from Jan 1, 2022.
  3. Class C and D devices that are not listed in Circular 30/2015, can be imported with a Classification Certificate until Dec 31, 2022 after which a MA License will be required.
  4. Class B MA License application have the same requirements as Class A devices starting Jan 1, 2022.
  5. For Class C and D devices with reference country approval, the technical review is waived. MOH application target proceeding time will be 10 days with reference country approval. (Note: China and Korea have been added to the US, Europe, Japan, Australia and Canada as reference countries.)
  6. MA Licenses will be issued without an expiration date (instead of the previous 5-year validity period).
  7. Registration Holders do not need to be the initial importer; and multiple importers/distributors can be authorized under the same MA license.

For more information on the registration process in Vietnam, please see our page on the topic here.

Application Fees and Target Review Times in Vietnam

Class DMEC Fees Standard Review Time Review Time w/ Reference Country Approval
A VND 1 million US$43 Within 5 days Within 5 days
B VND 3 million
US$130
Within 5 days Within 5 days
C VND 5 million
US$216
60 days* 10 days*
D VND 5 million
US$216
60 days* 10 days*

*MA Licenses have not been issued for Class C or D applications since the new regulations were implemented and therefore, Review Times for Class C and D applications are not accurate at this time. 

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Asia Actual specializes in helping medical device manufacturers grow their sales in Asia with experienced, bi-lingual commercial and regulatory experts on the ground in each market.

Contact Asia Actual today with any questions on how the rocky implementation of Decree 98/2021 may affect your business.

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