Medical Device and IVD Registration and Approval in Vietnam

ANSWERED ON THIS PAGE:

• What is the medical device registration process in Vietnam?
• How does Vietnam classify medical devices and IVDs?
• Is an in-country representative required for foreign manufacturers?

Vietnam medical device regulations

Medical devices and in vitro diagnostic devices (IVDs) are regulated by the Department of Medical Equipment and Construction (DMEC) under the Ministry of Health in Vietnam.

Vietnam is in the process of aligning its national legislation with the Association of Southeast Asian Nations (ASEAN) Medical Device Directive (AMDD). In November 2021, the Vietnamese government issued Decree No. 98/2021/ND-CP on the Management of Medical Equipment, which introduced a new legal framework for regulating medical devices and replaced the former regulations. This system introduced increased regulatory requirements, including a formal approval process for Class C and D medical devices, and the need for an in-country representative. It has recently been amended by Decree No. 07/2023/ND-CP to extend some of the transitional provisions for registration according to the requirements of Decree No. 98/2021.

Emergo has the expertise to help you navigate regulatory requirements and begin selling your device in Vietnam.

Registration routes in Vietnam

Under Decree No. 98/2021, medical devices and IVDs require a Marketing Authorization Code (MAC) to be imported and sold in Vietnam. With the publication of Decree No. 07/2023, some Class C and D devices are subject to ongoing transitional provisions.

The pathway to obtain a MAC is based on the classification of the device. The first step in the Vietnam regulatory process is therefore to determine the correct classification of your medical device. Based on the classification, the following regulatory pathways exist:

• Applicants of all Class A and B medical devices and IVDs must submit a Declaration of Applied Standards application to the local/regional Department of Health where the applicant is established to obtain the MAC.
• Applicants of Class C and D devices and IVDs must submit a Marketing Authorization Registration application to the Ministry of Health for review and approval to obtain the MAC.

A manufacturing facility must have a valid ISO 13485 certificate as part of the dossier requirements for both the Declaration of Applied Standards and the Marketing Authorization Registration pathways. Additionally, starting January 1, 2024, dossiers for Class C and D devices must be in the ASEAN Common Submission Dossier Template (CSDT) format.

Decree No. 98/2021 established that MACs for all devices do not expire. All existing MACs granted under the new regulation or its predecessor, Decree No. 36/2016, are considered valid and therefore do not require renewal.

Transitional arrangements are in place for certain Class C and D devices:

• Class C and D devices that were exempted from the Import License requirement under the prior regulatory regime may be imported without registration through the end of 2024 as long as the importer declares a Classification Result for the device in DMEC’s online portal. 
• Import Licenses issued for Class C and D medical devices and IVDs from January 1, 2018, to December 31, 2021, under the prior regulatory regime will remain valid through the end of 2024. Additionally, Import Licenses that were applied for before January 1, 2022, but have not yet been granted, will be valid through the end of 2024 once issued.
• MACs issued for IVDs from January 1, 2014, to December 31, 2019, will remain valid through the end of 2024, and those issued in 2020 or 2021 may be used until the expiration date indicated on the registration certificate.

Medical device classification in Vietnam

Vietnam’s medical device classification system is composed of four (4) classes of increasing risk:

Part II, Appendix I of Circular No. 05/2022/TT-BYT outlines the 16 classification rules, which are aligned with the AMDD, to determine a medical device’s class.

Let Emergo assist you with Vietnam’s regulatory approval process

Emergo is an international consulting firm that works exclusively for medical device and IVD companies. Our experienced team is equipped to assist with the Vietnam registration process. Here's how we can help:

• We can assist you in properly classifying your device to facilitate the registration process.
• Emergo can compile the necessary documentation for the MAC application.
• Our experienced consultants can update your existing quality system to meet ISO 13485 QMS requirements.

With offices in the Middle East, Europe, North America and beyond, Emergo can help you start selling in Vietnam and in markets around the world. Please contact us for more information on our medical device and IVD registration services for Vietnam.

Frequently asked questions about Vietnam

Do I need an in-country representative?
Foreign manufacturers must appoint an in-country representative called a Marketing Authorization Holder (MAH). The MAH submits the medical device application through DMEC’s online system and is responsible for communication with the authorities during review and after approval. The MAH is also responsible for issuing Letters of Authorization, which allow distributors/importers to perform distribution/import activities.

Emergo does not provide Vietnam MAH services at this time but can provide contact details for a qualified firm, if of interest.

Do we need Country of Origin approval to be eligible for registration in Vietnam?
A valid Certificate of Free Sale (CFS) is required for imported medical devices. Reference country approval is not required. However, Class C and D devices that have obtained a CFS or other proof of market authorization from a recognized reference market may partake in the Fast Track Approval scheme. Reference markets include Japan, Canada, Australia, the United States (U.S.), the European Union (EU)/EU member states, the United Kingdom (U.K.), Switzerland, China, South Korea or other competent authorities recognized by the Vietnamese Ministry of Health.

Emergo can advise further if your product is eligible to be registered even if you don't have approval in your home market.