Significant Changes Made to the Medical Device Registration Process in Vietnam

On November 8^th, the Ministry of Health (MOH) officially released Decree 98/2021 ND-CP, which implements significant new changes to the rules governing medical device registration in Vietnam (the English version can be found here). The new regulatory requirements under Decree 98/2021 ND-CP will go into effect on January 1, 2022 and will replace previously issued Decree 36/2016, Decree 169/2018, and Decree 03/2020/ND-CP. Manufacturers seeking registration in Vietnam can now apply for Market Authorization (MA) licenses which will remain valid indefinitely and require 10 to 90 days for the registration process. All aspects of the new Decree streamline compliance requirements compared to earlier plans and are expected to be received positively by industry.

Important Highlights of Decree 98/2021:

1. All existing, or newly issued Import Licenses will remain valid until Dec 31, 2022. (No new Import License applications will be accepted after Dec 31, 2021.) Class C and D devices with Import Licenses will avoid a technical review and be processed in 10 days when applying for a Market Authorization (MA) License.
2. 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.)
3. 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.
4. 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.
5. Class B MA License application will have the same requirements as for Class A devices starting Jan 1, 2022.
6. 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.)
7. MA Licenses will be issued without an expiration date (instead of the previous 5-year validity period).
8. Registration Holders do not need to be the initial importer; and multiple importers/distributors can be authorized under the same MA license.
9. Third Party Classification process has been removed and is now the responsibility of the applicant/registration holder.
10. 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.

Regulatory Requirements for New Medical Devices

Manufacturers seeking registration in Vietnam will have a few potential pathways to register their products depending on the 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. Originally, Class A and B devices were supposed to undergo a quick administrative review by the Health Department of the province where the Registration Holder is located, with approval granted within 1-2 weeks. However, after the MOH’s meeting on Dec. 31, 2021, the MOH will immediately grant the registration number for Class A and B applications and then conduct a post-market review. This significantly reduces the review time for Class B devices from 60 days.

Class C and D devices listed in Circular 30/2015 can apply for an Import License if submitted before January 1, 2022 or apply for a Market Authorization (MA) license. Import Licenses will expire December 31, 2022 while MA licenses will remain valid indefinitely. A full list of products found in Circular 30/2015  can be found further below and include ventilators, infant incubators, pacemakers, x-ray machines, MRIs, hemodialysis devices, etc.

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 their registration in Vietnam like other markets.

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

Under the new medical device regulations, the MOH also updated the expedited review process for medical devices with at least 1 Reference Country approval, which includes the USA, Canada, Europe, Japan, Australia, Korea and China. 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.

Additionally, to help manufacturers already on the market make a smooth transition to MA licenses, the MOH will also waive the technical reviews for Class C and D for products with an Import License.