Medical Device product registration in Vietnam is overseen by the Department of Medical Equipment and Construction (DMEC), under the Ministry of Health (MOH). Registration requirements for medical devices in Vietnam are currently in a state of transition.
New rules governing the registration of medical devices were published on November 8, 2021 with Decree No. 98/2021. This new Decree overrules previous Decree No. 36/2016/ND-CP as amended with Decree No. 169/2018/ND-CP and Decree No. 03/2020/ND-CP. Implementation for the new rules will begin January 1, 2022 with a 1-year transition period for documentation and some Class C and D products.
Important Medical Device Regulations
Decree No. 98/2021/ND-CP – effective Jan 1, 2022
Circular No. 30/2015/TT-BYT – effective since 2015 and will transition out by Dec 31. 2022
Decree No. 36/2016/ND-CP–effective Jan 1, 2020 and now overruled by Decree 98/2021
Decree No. 169/2018/ND-CP – amended Decree 36 adds fast track approval; and CSDT requirement (now overruled by Decree 98/2021)
Decree No. 03/2020/ND-CP – amended Decree 36 details implementation process of new Rules (now overruled by Decree 98/2021)
Decree No. 111/2021 – Amends Decree No. 43/2017 and Updates Labeling requirements
Medical Device Status
In Vietnam, Medical devices are any equipment, tools, materials and chemicals, necessary software, used alone or in combination that aim to prevent, examine, diagnose and/or mitigate illness or check, replace, modify or offer surgical support during examinations and treatment.
Under new rules, Software is considered a medical device but not regulated.
Vietnam closely follows GHTF guidelines for medical device classification with Class A, B, C and D devices, ranging from low to high risk. Previously, medical device risk classification in Vietnam had to be determined by a locally certified organization or person but under the new regulations, the Registration Holder can classify the product as part of the application.
|DMEC Fees / MA Licenses||Review Time|
|Class A||VND 1 million US$43||Immediate|
|Class B||VND 3 million|
|Class C||VND 5 million|
|10 to 90 days|
|Class D||VND 5 million|
|10 to 90 days|
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Regulatory Pathway in Vietnam
The first step toward regulatory compliance in Vietnam is to classify the product in accordance with its intended use and risk level. Under the previous regulations, the classification needed to be performed by a certified Classification Agent but under the new rules, the Registration Holder is permitted to classify the product.
Beginning January 1, 2022, all Class A and B products will require a Market Authorization (MA) License. Class A and B devices will undergo a quick administrative review by the Health Department of the province where the Registration Holder is located. The registration number will be issued immediately and significantly reduces the review time for Class B devices from 60 days.
Class C and D devices listed in Circular 30/2015 required an Import License prior to January 1, 2022 and will now need to apply for a Market Authorization (MA) license. Existing 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. This being said, manufacturers of these products are encouraged to obtain a MA License at their earliest convenience.
Regulatory Requirements for New Medical Devices
Class A and B devices are subject to a Notification process that is overseen by the provincial offices of the MOH. By handling these administrative reviews, the central MOH has more time to focus on Class C and D applications. Class C and D applications without a Reference Country approval or national standards will need to undergo a Technical Review which could take up to 90 days. Products with a Reference Country approval or the same national standards will avoid the Technical Review and should be approved in about 10 working days.
Applications will continue to require the same documentation as Import Licenses and MA Licenses for Class A until January 1, 2023. Updated in September 2022, Common Submission Dossier Template (CSDT) will be required for all applications beginning in 2024 instead of 2023.
The application current application requirements consist of administrative documents only (no technical file). Documentation for all Class devices may be submitted in Vietnamese or English until January 1, 2024 (updated in September 2022). Some documents like the IFU and Technical Summary will need to be in Vietnamese while others like the Letter of Authorization will need to be Legalized.
MA Licenses do not expire under the new Decree.
Vietnam has special labeling requirements for registered medical devices including the registration number and License Holder contract information. Complaint labeling may be affixed after Customs clearance.
Exemptions from the registration process are made for products used for RUO, testing, training, repair, exhibition, or donated devices
Note: As of September 2022, no Class C or D MA Licenses have been issued. Please see our article on the September 14, 2022 MOH seminar providing an industry update and plan for beginning to issue C and D MA Licenses
Quality Systems Conformity Assessment
A Quality Systems Conformity Assessment is required for Class B, C and D devices and can be demonstrated with an ISO 13485:2016.
Expedited Review for 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 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 allow waive technical reviews for Class C and D for products with an Import License.
Australia – Canada – European Union – Japan – United States – China – Korea
Per Article 62 of Decree 98/2021 and implemented in July of 2022, ALL advertising material (e.g., print, internet, or video), including materials for Direct to Consumer (DTC) and healthcare professionals must be uploaded to the public portal. Once uploaded, a unique number is provided which then needs to be included in the advertising materials when placed on the market. Under this new plan, advertisements may be removed from the market if they’re found to not meet the MOH’s requirements. There is no fee for uploading materials to the portal.
Advertising materials must contain the following information:
- Name of medical equipment, type, product code, manufacturer, manufacturing country;
- Circulation number;
- feature, the effect;
- Name and address of the license holder of the free-sale registration number or the organization authorized by the holder of the free-sale registration number of the medical equipment;
- Warnings related to users’ health and storage conditions (if any).
Materials meeting any of the following descriptions do not need to be uploaded to the public portal.
- Do not refer to the medical device name;
- Only list names and technical specifications of medical equipment but have no information on features and effects;
- Scientific research papers;
- Clinical documentation;
- Training materials supporting product manuals.
Validity and Renewal
Once issued, an MA License does not expire. All Import Licenses expire on December 31, 2022.
License Holder Requirements
Medical device manufacturers must appoint, and grant Power-of-Attorney to a local, registered company in Vietnam to submit registration applications and act as the Registration Holder. Under the new regulations, Registration Holders can authorize an unlimited number of distributors to import under the MA License, as well as participate in public tenders.
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MEDICAL DEVICE CLASSIFICATION
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