This page covers the regulatory authority, device classification, registration process, local representative requirements and FAQs for medical device registration in Vietnam. Medical devices in Vietnam are regulated by the Infrastructure and Medical Devices Administration (IMDA) of the Ministry of Health (MOH), and EVERBIZ can support you through the entire process from classification to registration.
1. Regulatory Framework
Medical devices in Vietnam are regulated by the Infrastructure and Medical Devices Administration (IMDA) under the Ministry of Health (MOH) (restructured from the former DMEC in January 2025).
Core regulations:
-
Decree 98/2021/ND-CP – the main framework (effective 1 January 2022)
-
Decree 07/2023/ND-CP – first amendment
-
Decree 04/2025/ND-CP – latest amendment (effective 1 January 2025)
-
Consolidated Document No. 08/VBHN-BYT – consolidated text issued in March 2026
The classification rules are aligned with the ASEAN Medical Device Directive (AMDD).
2. Risk Classification and Submission Routes
Vietnam uses four risk classes:
| Class | Risk | Submission route | Approving authority |
|---|---|---|---|
| Class A | Low | Declaration of Applied Standards | Provincial Department of Health |
| Class B | Low–moderate | Declaration of Applied Standards | Provincial Department of Health |
| Class C | Moderate–high | Marketing Authorization | Ministry of Health (MOH) |
| Class D | High | Marketing Authorization | Ministry of Health (MOH) |
There are 16 classification rules, set out in Annex I of Circular 05/2022/TT-BYT.
3. Registration Process
Step 1 — Appoint a local representative / MAH: Foreign manufacturers must appoint a licensed Vietnamese Marketing Authorization Holder (MAH) as the legal entity responsible for submissions and compliance.
Step 2 — Product classification: Determine Class A–D under the 16 rules of Circular 05/2022. Multi-purpose products are classified at the highest applicable risk class.
Step 3 — Prepare the application documents
-
Administrative documents: MAH power of attorney (POA, consular legalization required), ISO 13485 certificate, Certificate of Free Sale (CFS), manufacturer qualifications
-
Technical documents: technical dossier in CSDT format (product description, risk management, performance verification, clinical evidence, etc.)
-
Vietnamese versions: IFU, technical summary and labeling must be in Vietnamese
Step 4 — Submission
-
Class A/B: submit a Declaration of Applied Standards to the Provincial Department of Health
-
Class C/D: submit a Marketing Authorization application to the MOH
Step 5 — Review and approval: Once approved, a Marketing Authorization Code (MAC, registration number) is issued. If the reviewer requests additional information, the applicant must respond within 90 days, with a maximum of 5 rounds, after which the application is rejected.
4. Expedited Review: Reference Country Route
Products approved in the following countries/regions can use a fast track:
US FDA, EU, UK, Switzerland, Canada, Japan (MHLW/PMDA), Australia TGA, Korea MFDS, China NMPA
With reference-country approval, Class A/B devices can usually be approved within 1 week; for Class C/D, some technical documents can be waived, significantly shortening the overall timeline.
5. Key Compliance Requirements
-
ISO 13485 – mandatory for all classes; the certificate must cover the specific device and have at least 6 months of remaining validity at submission
-
CSDT technical dossier – prepared according to the ASEAN common submission template
-
Vietnamese localization – IFU, labeling and technical summary must be translated
-
Consular legalization – foreign documents such as the POA and CFS must be legalized
6. Validity of Registration
Under Decree 98, MACs for Class A, B, C and D are valid indefinitely, with no need to renew every 5 years (a major improvement over the old system). However, an MAC can be revoked for violations (such as unreported significant changes or product safety issues).
7. Post-Market Obligations
-
Adverse event reporting and product recalls
-
Price declaration – some devices may only be sold after their prices are published in the MOH system (simplified by Decree 07/2023)
-
Registration updates for changes in design, indications or key parameters
-
Retention of complaint and sales records
8. Recent Key Changes
| Date | Change |
|---|---|
| January 2025 | DMEC restructured into the IMDA; Decree 04/2025 extended certain simplified Class C/D routes to 30 June 2025 |
| 1 July 2025 | All transitional arrangements end and the Decree 98 regime is fully enforced – Class C/D devices must hold an MAC to be imported and sold |
| March 2026 | Consolidated Document No. 08/VBHN-BYT issued, consolidating all current regulations into a single reference text |
How EVERBIZ Can Help
EVERBIZ has offices in Shanghai, Hong Kong, Germany, Austria, Singapore, Malaysia, Thailand and Vietnam. For the Vietnam market, we offer:
- Product classification and registration pathway planning
- Preparation and review of CSDT technical documentation and Vietnamese-language materials
- Local authorized representative / registration holder arrangements
- Submission, responses to deficiency letters and progress tracking
- Post-market compliance maintenance (changes, renewals, adverse event reporting)
Contact us for a Vietnam medical device registration plan and quote, or see our registration services for other countries and regions.
Vietnam Medical Device Registration FAQs
Which authority regulates medical devices in Vietnam?
The Infrastructure and Medical Devices Administration (IMDA) under the Ministry of Health (MOH); the core regulation is Decree 98/2021/ND-CP and its amendments.
How are medical devices classified in Vietnam?
By risk into Classes A, B, C and D. Class A and B devices follow a declaration of applied standards, while Class C and D devices require a marketing authorization (MAC).
What key documents are needed for registration in Vietnam?
Mainly the ISO 13485 certificate, CSDT technical dossier, Vietnamese labeling and IFU, and legalized foreign documents such as the power of attorney (POA) and Certificate of Free Sale (CFS).
Do Vietnamese medical device registrations need to be renewed?
No. Under Decree 98, marketing authorizations (MAC) for Classes A, B, C and D are valid indefinitely, but can be revoked for violations.
Related Reading
- Vietnam Joins the Hague Apostille Convention on 11 September, Opening a Window to Faster Cross-Border Medical Device Registration
- Vietnam’s New Medical Device Labeling Rules Take Effect on 1 July 2026: Five Mandatory Items, Supplementary Labels and Font-Size Requirements Explained
- Vietnam IMDA Medical Device Registration