VietNam Requires Resubmission of Many Medical Device Registration Applications

Thousands of Pending Class B, C, and D Registration Applications Affected

On December 30, the VietNam Ministry of Health (MOH) held a meeting to lay out new plans regarding several key issues to transition all medical devices under the new Medical Device regulations. Since 2017, the MOH had been accepting applications for Market Authorization (MA) Licenses under Decree 36/2016. Some licenses were issued with an effective date of January 1, 2022, but many applications remained under review. Then in November of 2021, Decree 98/2021 was announced with slight changes to the application requirements for MA licenses. So on January 1, 2022 all unapproved Class B, C and D MA License applications have been returned for resubmission for compliance to the new requirements.

Regarding Class A and B devices:

• all pending Class B applications will be returned and must be resubmitted in compliance with Decree 98/2021
• no new application fees will be applied to re-submitted applications
• new Class B registration applications must include a Declaration of Conformity
• new Class B registration applications must now include clinical evaluation report as part of the Technical Summary
• new Class A and B application will be issued a registration number upon submission (immediate approval)
• new Class A and B application which are found insufficient upon post-submission review will be subject to cancellation

Regarding Class C and D devices:

• all pending Class C and D application will be returned to for must be resubmitted in compliance with Decree 89/2021
• no new application fees will be applied to re-submitted applications
• new Class C and D registration applications must now include clinical evaluation report as part of the Technical Summary

The new application requirements are not particularly onerous, however there are an estimated 5,000 Class B applications and 7,000 Class C and D applications affected by this change.

Important Highlights of Decree 98/2021:

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.)
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 will have the same requirements as for 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.
8. Third Party Classification process has been removed and is now the responsibility of the applicant/registration holder.
9. Asia Actual recommends manufacturers of all product categories with Reference Country approval seek an MA license as soon as possible as they do not expire, are reviewed quickly, and can be registered with relatively little documentation.

Application Requirements for New Medical Devices

Manufacturers seeking to enter the VietNamese market will have a few potential pathways depending on their product’s classification, category, and current approval status. Classification is based on risk and closely follows GHTF guidelines. More information can be found in Circular 39/2016. Class A and B devices will immediately receive a registration number by the Health Department of the province where the Registration Holder is located. This significantly reduces the review time for Class B devices from 60 days. The provincial MOH office will then conduct reviews of the documentation submitted and recall any products found to not have sufficient documentation.

All Class C and D devices listed in Circular 30/2015 must now apply for a Market Authorization (MA) license prior to importing. MA licenses will remain valid indefinitely.

Class C and D devices not listed in Circular 30 can continue to be freely imported through December 31, 2022 with only a classification document. However, Asia Actual encourages all manufacturers of Class C and D products, including those not listed in Circular 30, seek a MA license sooner rather than later to avoid any delays if there is a swell of applications as the deadline nears. Additionally, since MA licenses do not expire under the new Decree, manufacturers don’t need to worry about renewing in a couple years.

The MOH has also postponed the implementation of CSDT documentation requirement until January 1, 2023. Until then, all MA license applications must include, but are not limited to, the following documents:

• Application Form
• Certificate of Classification, Letter of Authorization, Declaration of Conformity, etc.
• Certificate of Free Sale (CFS)
• Certificate of QMS (ISO 13485)
• IFU and Technical Summary issued by the Registration Holder in VietNamese
• VietNamese labels

Once approved, the MOH will update the disclosure portal within 1 day,

Beginning January 1, 2023, all new Class C and D products will require a MA license prior to importation and applications submitted after this date will need to be submitted in accordance with CSDT. Since registrations won’t expire anymore, Registration Holders should maintain access to latest product information, distribution records, and up to date QMS documentation to ensure timely response should a provincial MOH office request to see anything.

Expedited Review for Products with Reference Country Approval

The MOH has also updated the expedited review process for medical devices with at least 1 Reference Country approval, which includes the USA, Canada, Europe, Japan, or Australia. As part of Decree 98/2021, the MOH extended acceptable Reference Country approval to China’s NMPA and Korea’s MFDS. Products with an approval from at least one of these markets will still need to submit the required documentation (technical summary, label, IFU, brochure until Dec. 31, 2022, then CSDT) but will not undergo a technical dossier evaluation which intends to shorten the wait time from 60 working days to 10.

Transitioning from Import Licenses to MA Licenses

Manufacturers with Import Licenses should apply for an MA license as soon as possible since Import Licenses will expire December 31, 2022 and MA licenses don’t expire. Additionally, since the required documentation for MA licenses during 2022 is the same as it was for Import Licenses, manufacturers should be able to reuse much for the previously utilized documentation. Furthermore, to help manufacturers already on the market make a smooth transition to MA licenses, the MOH will waive technical reviews for Class C and D for products with an Import License.