Vietnam Medical Device Registration: 20 Questions on IMDA, MAH, Classification and CSDT (2026)

Vietnam is one of the fastest-growing medical device markets in ASEAN, with more than 90% of medical equipment imported. This FAQ summarises the core rules for registering medical devices in Vietnam. It has been checked against Vietnam’s current regulations – Decree 98/2021/ND-CP and its amendments Decree 07/2023/ND-CP and Decree 04/2025/ND-CP, together with Circular 05/2022/TT-BYT (classification rules) – for manufacturers planning to enter Vietnam.

1. Regulatory framework

Q1. Who regulates medical devices in Vietnam?

The national regulator is the Department of Medical Infrastructure and Devices (IMDA) under the Ministry of Health (MOH) – renamed from the former DMEC in January 2025. IMDA handles the registration review of Class C and D products, issuance of circulation numbers, import management and post-market surveillance. Declarations for Class A and B products are published through the Provincial Health Department where the MAH is located.

Q2. Which regulations currently govern medical devices in Vietnam?

The core framework consists of:

• Decree 98/2021/ND-CP (in force since 1 January 2022): the umbrella decree for medical device management, replacing Decree 36/2016 and other older rules;
• Decree 07/2023/ND-CP and Decree 04/2025/ND-CP: amendments and supplements to Decree 98 (including transitional arrangements);
• Circular 05/2022/TT-BYT: the classification rules (16 rules), the list of products requiring testing, the list of products requiring import licences and other implementing details.

The system is aligned with the ASEAN Medical Device Directive (AMDD) and the ASEAN CSDT submission template.

Q3. Can a foreign manufacturer file a registration application with the MOH directly?

No. A foreign manufacturer must appoint a Vietnamese local entity as the Marketing Authorisation Holder (MAH). The MAH is the applicant that submits through the IMDA online system and bears all post-market legal responsibilities, including liaison with the regulator, adverse event reporting, recalls and change management. The letter of authorisation (POA/LOA) must be legalised.

Q4. Can the MAH and the distributor be the same company?

Yes, but it carries significant risk. Vietnamese registrations cannot be transferred in principle: if the certificate is held in the distributor’s name and the cooperation ends, the manufacturer usually cannot transfer the certificate to a new distributor and may face re-registration. The industry consensus is therefore to appoint an independent third-party MAH (decoupled from commercial sales) so that the certificate asset stays under the manufacturer’s control, while distributors obtain import and sales rights through a letter of authorisation (LOA).

2. Product classification

Q5. How are medical devices classified in Vietnam?

Vietnam uses the ASEAN-harmonised four-tier risk classification (Class A/B/C/D), determined under the 16 classification rules of Circular 05/2022/TT-BYT:

IVDs have their own classification rules (for example HIV, Ebola and newborn genetic screening assays are Class D). Combination products are classified by their highest-risk component.

Q6. Who decides the classification?

Under Decree 98, the MAH (licence holder) determines the classification when filing – a certified classification body is no longer mandatory. However, misclassification is one of the most common reasons for rejection, so products near a boundary should be professionally pre-assessed before submission.

Q7. What is the essential difference between the Class A/B and Class C/D routes?

This is the most important dividing line in the Vietnamese system:

• Class A/B: a declaration route (Declaration of Applied Standards) reviewed for administrative completeness by the Provincial Health Department where the MAH is located – a formality check;
• Class C/D: a Marketing Authorisation (MA) application to MOH/IMDA with full technical review and a complete technical dossier in CSDT format.

Note: a Class A/B filing results in a published declaration, not a “registration certificate”; only Class C/D results in a true marketing authorisation.

3. Dossier, process and timelines

Q8. Which core documents does a registration application require?

The core dossier includes:

1. Letter of authorisation (POA/LOA appointing the MAH), legalised (Hague apostille);
2. Certificate of Free Sale (CFS) issued by the country of origin or a reference country, legalised;
3. ISO 13485 certificate covering the legal manufacturer, the production site and the relevant products (mandatory for all classes);
4. Product classification result;
5. CSDT technical dossier (mandatory for Class C/D, covering risk management, verification and validation, clinical evaluation, etc.);
6. Vietnamese-language labelling and instructions for use (IFU);
7. Product catalogue;
8. Warranty certificate for equipment that is not single-use;
9. Clinical evaluation summary for Class C/D.

Foreign documents must be legalised (Hague apostille) and accompanied by notarised Vietnamese translations.

Q9. What is CSDT, and when did it become mandatory?

CSDT (Common Submission Dossier Template) is the ASEAN-harmonised submission template covering product description, risk analysis, verification and validation, clinical evidence, labelling and other modules. Since January 2024, Class C/D products must be submitted in CSDT format, and C/D applications may also require a CSDT assessment report from a designated institute (for non-IVD products, the National Institute of Medical Devices and Medical Engineering; for IVDs, the National Institute for Control of Vaccine and Biological Products).

Q10. Which reference-country approvals does Vietnam accept? Is there a fast track?

Yes. Under Decree 98, products already approved in a reference market (US FDA, EU CE, Japan, Australia, Canada, the UK, Switzerland, China’s NMPA or South Korea) with a valid CFS can use the expedited review route: the regulator relies on the reference country’s review conclusion, usually waiving the full technical assessment and substantially shortening the timeline (in theory a Class C/D review can be compressed to around 10-20 working days). China’s NMPA certificate is explicitly recognised as a reference qualification – a substantial advantage for Chinese manufacturers. One caveat: certificates issued by provincial medical products administrations are not accepted; Vietnam only recognises Class III NMPA certificates issued by the National Medical Products Administration.

Q11. How long does registration take?

It varies considerably by class and route:

• Class A: administrative declaration, usually completed within a few working days;
• Class B: declaration with the Provincial Health Department, in practice around 1-2 weeks to 1 month;
• Class C/D: the official target under the fast track is roughly 10-90 days, but backlogs mean real-world timelines often run to several months or longer; plan for 2-6 months overall from document preparation and notarised translation to licence (longer for standard review without reference-country approvals).

Dossier completeness is the biggest variable – repeated deficiency letters will significantly delay the licence.

Q12. How long is a Vietnamese registration valid? Does it need renewal?

Under Decree 98, circulation numbers (registration numbers) for all classes are valid indefinitely – there is no 5-year renewal, a major improvement over the old Decree 36 system; certificates issued under the old law remain valid. The only exception is registrations granted under the emergency procedure, which carry a limited validity period.

“Indefinitely valid” does not mean “once and done”, however: the ISO 13485 certificate must remain valid, product changes require variation filings, and post-market vigilance obligations continue.

Q13. How much are the official fees?

Official fees are modest: around VND 500,000 for Class A, VND 1,500,000 for Class B and VND 3,000,000 each for Class C and D. In addition, under an MOH notice registration fees are halved until 31 December 2026 – a window-period benefit. The real cost drivers are MAH service fees, translation and notarisation, CSDT preparation and testing.

Q14. What are the labelling and IFU requirements?

Labels and instructions for use (IFU) must be in Vietnamese. Labels for imported devices must comply with Vietnam’s goods labelling rules (Decree 43/2017 as amended by Decree 111/2021 and subsequent updates), covering the product name, model, manufacturer, MAH details, circulation number, manufacturing/expiry dates and other elements. Key documents such as the technical summary must also be provided in Vietnamese; machine translations are not accepted in review.

4. Post-market and compliance operations

Q15. What happens if product information changes after licensing?

The MAH must file a variation or notification with the regulator. Changes to the product name, models and specifications, manufacturer information, production site, labelling or IFU follow either a notification or a re-review procedure depending on their nature. Placing product on the market without processing a required change is a compliance violation and can lead to suspension or revocation of the circulation number.

Q16. What are the post-market obligations?

The MAH’s ongoing obligations mainly include:

• Adverse event monitoring and reporting (vigilance);
• Suspension of supply, recall and disposal of defective products;
• Change management and maintenance of registration information;
• Cooperation with inspections by MOH/IMDA and the Provincial Health Departments;
• Product-specific requirements such as price declaration and advertising content review for certain products.

Q17. Is a registration certificate required before every import?

In principle a circulation number must be obtained before import and sale. Under transitional policies the validity of the former import permits has been extended several times through Decree 07/2023 and Decree 04/2025, and Class C/D products not on the mandatory registration list may be imported with classification documents during a transition period. These transitional arrangements are time-limited and adjusted batch by batch: manufacturers should follow the latest decree texts and complete formal MA registration early to avoid supply disruption once the window closes.

Q18. How do importers and distributors obtain legal status?

Import and distribution by a foreign manufacturer must be performed by a Vietnamese local entity: the MAH issues a letter of authorisation (LOA) to the importer/distributor, which then imports and sells under its valid business licence with the corresponding medical device scope. One MAH can authorise several distributors at the same time – exactly the advantage of the independent-MAH model: the manufacturer can add, reduce or replace distributors freely without touching the registration.

5. Practical strategy

Q19. What are the most common pitfalls for Chinese manufacturers in Vietnam?

Five problems appear frequently in practice:

1. Tying the certificate to a distributor: the registration is held in the name of an exclusive distributor, and when the cooperation breaks down the certificate cannot be transferred – the market is effectively held hostage;
2. Misclassification: applying the Chinese or CE classification directly instead of checking each product against the 16 rules of Circular 05/2022, leading to rejection;
3. Defective document authentication: POA or CFS without apostille, or Vietnamese translations that are not notarised;
4. Incomplete ISO 13485 coverage: the certificate does not cover the product being filed, or the production site does not match;
5. Underestimating the CSDT workload: preparing only administrative documents as under the old regime instead of a complete technical dossier, causing repeated deficiency cycles for Class C/D.

Q20. Is 2026 a good time to enter the Vietnamese market?

The window is clear from both the regulatory and the commercial perspective:

• Regulatory: the new framework (the Decree 98 system) is fully in place and markedly clearer; registrations are valid indefinitely, increasing the value of the certificate asset; China’s NMPA is a recognised reference country and the fast track is available; official fees are halved until the end of 2026.
• Market: Vietnam has a population of over 100 million and rising healthcare spending, with more than 90% of equipment imported; demand is strong in imaging, IVD, orthopaedics, dialysis and home monitoring.

In short: a period of regulatory clarity, a fee-reduction period and the reference-country route are converging – 2026 is a cost-effective time to file. Manufacturers should start by mapping their product classifications, preparing the CFS and ISO 13485, and securing a reliable Vietnamese MAH as early as possible.

Grzan operates its own subsidiaries in Hanoi and Ho Chi Minh City, providing Vietnamese local MAH services (licence held by our own entity, not outsourced or attached to distributors), classification pre-assessment and CSDT dossier preparation, end-to-end agency for Class C/D marketing authorisations and A/B declarations, importer and distributor LOA structures, and post-market compliance management for the Vietnamese market.

This article is compiled from Vietnam’s currently published regulations and is for reference only; it does not constitute formal legal advice. Regulations may be updated – always refer to the decree texts and regulatory requirements in force at the time of submission.