VIETNAM · MEDICAL DEVICES

Vietnam Class A/B declaration vs Class C/D registration: choosing the route

In Vietnam, Class A and B medical devices go through a declaration of applicable standards (Công bố tiêu chuẩn áp dụng), while Class C and D devices require registration for circulation (Đăng ký lưu hành). Which route applies depends on the device’s risk class under Vietnamese rules. A CE certificate or Chinese registration can serve as evidence, but it does not replace Vietnamese classification or market-entry procedures.(Source: Consolidated text 08/VBHN-BYT, Articles 4, 5 and 21)

For an overseas manufacturer, the most useful output at project start is a single table: product, Vietnamese class, filing route and evidence gaps. This article covers how to build that table. For the local licence holder, the overall process and our services, see Vietnam medical device registration.

Step one: define the product scope and its Vietnamese risk class

Article 4 sets four classes, from A (low risk) to D (high risk). Under Article 5, where one intended use could fall into more than one class, or several intended uses fall into different classes, the highest class applies; devices used together are classified separately, and detailed classification rules are set by the Ministry of Health.(Source: 08/VBHN-BYT, Articles 4 and 5) You cannot drop a medical use that remains in the IFU to shorten the filing, nor simply adopt the class a competitor used for a similar product.

Classification must be carried out by the organisation that files the declaration or registration in Vietnam, and that organisation is accountable for it. If a classification understates the risk or relies on forged documents, the Ministry of Health can withdraw the result; any circulation number based on it is withdrawn, stock cleared through customs but not yet sold must be withheld and recalled, units already sold are handled according to whether they threaten patient health, and the product must be refiled under the correct class.(Source: 08/VBHN-BYT, Article 5(6), Articles 6 and 7)

Give your Vietnamese filer one consistent version of the intended use, mode of action, intended users, body contact, model differences and labelling. For IVDs, also state the analyte, whether the test is qualitative or quantitative, the clinical use and the setting. List any differences between models item by item so the filer can confirm class and filing scope; a shared product name helps with searching but settles nothing.

Where is each route filed, and what does it produce?

(Source: 08/VBHN-BYT, Articles 21, 25, 28, 29 and 32; Ha Tinh provincial government portal on Circular 44/2025) After the Ministry’s reorganisation in August 2026, the Department of Medical Infrastructure and Equipment (Cục Hạ tầng và Thiết bị y tế) remains one of its units.(Source: Decree 313/2026/NĐ-CP, Article 3)

A Class A/B declaration number is a circulation number in law, just like a registration certificate. After publication the holder remains responsible for the accuracy of the dossier and the classification, and should keep the published record and the matching document versions.

Class C/D: which registration case applies?

Once a device is confirmed as Class C or D, Articles 29 and 30 determine which case applies. Evidence and review times differ considerably, so use the table below as a route-selection checklist:

The common documents are the application, a valid ISO 13485 certificate, the product owner’s letter of authorisation and the warranty confirmation, subject to the listed exceptions.(Source: 08/VBHN-BYT, Articles 29, 30 and 32)

The reference jurisdictions in Article 29(2) are the US FDA, Australia’s TGA, Health Canada, Japan’s MHLW or PMDA, EU member states, the UK, Switzerland, China’s central-level National Medical Products Administration (NMPA), Korea’s MFDS, and other issuing bodies recognised by the Vietnamese authorities. In practice, check the certificate type, the issuing authority and the products covered, item by item.

Chinese manufacturers should pay particular attention to the words “central level”. The text does not confirm that registration certificates or export sales certificates issued by provincial medical products administrations meet this condition, so confirm each document with your filer before submission rather than assuming it qualifies. Where a foreign certificate does not name the models to be sold, the intended use or the product owner, supply supporting evidence; a trademark or CE mark alone does not show that a whole product family qualifies for the fast track.

Article 32a separately provides for priority processing in listed cases, for example devices manufactured in Vietnam; devices whose type and product codes match a valid licence but where only the importer or registrant changes, or only the name of the manufacturing site or product owner changes (address unchanged); a new product code only because the old one was discontinued; and earlier applications whose query or refusal concerned only updating the validity of the authorisation letter, ISO 13485 certificate or marketing authorisation, or only amending the device name. The applicant must file a separate request for priority with supporting evidence, and the Ministry decides within 10 working days. A company’s launch date or a hospital’s procurement need is not, by itself, a basis for emergency registration or priority processing.(Source: 08/VBHN-BYT, Article 29(3), Article 32a(1)–(2))

Preparing documents: remove four common inconsistencies first

The Class A/B dossier is set out in Articles 26 and 27 and has nine items: the declaration form; a valid ISO 13485 certificate; the product owner’s letter of authorisation (where applicable); the warranty confirmation (single-use devices and some others excepted); a Vietnamese technical summary with the owner’s technical documentation (plus materials, manufacturing process, pre-clinical and clinical, and stability data for IVDs); a certificate of conformity or the product standard declared by the owner; the instructions for use; a sample label for Vietnam; and, for imports, a valid certificate of free sale. For imports, the decree requires the letter of authorisation, warranty confirmation and certificate of free sale to be consularly legalised. Vietnam has joined the Apostille Convention, and Decree 293/2026/NĐ-CP applies from 11 September 2026: public documents from member states with which the Convention applies in relation to Vietnam use an apostille instead of consular legalisation; documents from non-member states still need consular legalisation; and exemptions under treaties or law continue to apply. An apostille covers only public documents and not administrative documents dealing directly with commercial or customs operations, so manufacturer-issued documents such as the letter of authorisation usually need notarising first. Confirm the form required for each document with the authority before filing; for practical points, see Vietnam medical device registration now accepts apostilles. (Source: Decree 293/2026/NĐ-CP, Articles 5, 26 and 34) Quality certificates or certificates of free sale not in English or Vietnamese need a certified Vietnamese translation. Class C/D dossiers follow Articles 30 and 31 for the relevant case; emergency registrations have alternatives where consular legalisation is not available.(Source: 08/VBHN-BYT, Articles 26, 27, 30 and 31)

Whichever route applies, the following links are where problems most often arise. This table is a document-check method suggested by MediPass; it does not replace the statutory lists:

Illustrative scenario: three models in one series

This is a hypothetical example showing the order of decisions; it does not represent any actual client or approval outcome. A manufacturer plans to sell three models of one brand in Vietnam. Two share the same intended use and operation; the third adds a new clinical use. The foreign approval lists only the first two models.

• Class: confirm the Vietnamese class of each model against its actual intended use; the new use may put the third model in a higher class.
• Scope: set out the technical and intended-use differences between models so the filer can decide what can be filed together.
• Case: if the first two models are Class C/D with a reference approval, assess the fast track; the third model cannot borrow their foreign approval. Where evidence is missing, compare two options: file first for the fully evidenced scope, or complete the evidence and file everything together.

How should processing times be read?

Class A/B: Article 28 requires the dossier to be filed with the provincial Department of Health before the device is placed on the market; the Department publishes the number on receiving the dossier, including proof of fee payment. No substantive review period is set, but that does not mean zero lead time: document preparation, consular legalisation or apostille, fee payment and checking the published status still belong in the plan, and post-market checks apply as usual.

Class C/D: Article 32 sets review times by case (see the table above). Where additions are needed, the authority must state in writing what to supplement within a set period: 25 days where a national technical regulation or pattern approval applies, 40 days for other devices, 12 working days for the fast track and 8 working days for emergency registration. If the applicant does not respond within 90 days of the notice, or the dossier still falls short after the permitted rounds (3 for the fast track, 5 for cases under Article 30(1), (2) and (5)), the application must start again. Keep calendar days and working days separate, and plan for additions and document preparation on top.(Source: 08/VBHN-BYT, Article 28, Article 32(2)–(5))