Vietnam Class B Device Registration: Declaration Path and Rejections
Updated: 2026-11-05 · GRZAN Regulatory Team · Verification date 2026-10-20
Q: Do Class B and Class A follow the same route?
A: They share the same route in form, a Declaration of Applicable Standards filed with the provincial Department of Health, but the depth of documentation and the weight of responsibility differ. Both fall within the declaration regime under Decree 98, and both are a separate mechanism from the circulation registration review applied to Class C and D.
Q: What does Class B add to Class A?
A: Three things mainly. First, applying the classification rules is more complex: Class B covers largely medium-to-low-risk invasive or active products, where rule-based decisions are more readily contested. Second, the technical file requirements are more substantive, since evidence on performance, safety and biocompatibility rises with risk. Third, trading-side requirements step up at the same time: any entity buying and selling Class B, C or D devices must separately complete a Trading Eligibility Declaration (Decree 98, Articles 40 and 41), which does not apply to Class A. This is the extra company-side threshold for Class B that many manufacturers overlook.
Q: What is the official fee?
A: Under Circular 59/2023/TT-BTC the standard fee is VND 3,000,000 for Class B. During the 50% discount window, from 1 July 2025 to 31 December 2026, it is VND 1,500,000.
Q: What are the most common grounds for rejection of a Class B file?
A: Five recur:
- The classification is raised: if review concludes that the device should be managed as Class C, the file must move to national circulation registration and all earlier work is redone;
- The ISO 13485 scope does not cover the device: where the certificate names only a broad category such as “medical devices” without covering the specific product family, further evidence is usually requested;
- The technical file is left in English with no Vietnamese handling: labelling and instructions for use must be in Vietnamese, and while the technical file may stay in English it must be supported by the key Vietnamese materials;
- The LoA validity period or authorised scope is insufficient: it does not cover the declared models, or does not cover the full set of acts of declaring, holding and post-market support;
- The labelling does not comply with Decree 37/2026: font size, date format and device-specific particulars fall short.
Q: What happens if the classification is raised to Class C?
A: Accepting the outcome and reworking the file on the Class C route is the only compliant option. At that point, assess first whether the fast track is available, since a reference-country CFS or marketing authorisation can shorten the timeline considerably. The practical recommendation is therefore to prepare products on the A/B and C boundary to Class C evidential depth from the outset, which avoids a second round of rework.
Practical note: on a Class B project the most expensive line item is not the official fee but the cost of rework after the classification is raised. When making the classification decision, checking every rule against the text and keeping a written record is the cheapest insurance available.
Verification checklist (26 October 2026): (1) Decree No. 98/2021/NĐ-CP, Articles 25 and 26 (declaration) and Articles 40 and 41 (conditions and procedure for the Trading Eligibility Declaration); (2) Circular No. 05/2022/TT-BYT, classification rules; (3) Circular No. 59/2023/TT-BTC and Circular No. 64/2025/TT-BTC; (4) Decree No. 37/2026/NĐ-CP (labelling); (5) Decision No. 2495/QĐ-BYT (4 August 2025), schedule of administrative procedures.
Disclaimer
Prepared by GRZAN from publicly available regulation. It is provided for general information only and does not constitute legal advice. Legislation and official fees are subject to change by the competent authority.
About GRZAN
GRZAN (Global Regulatory Zone Access Navigator) — the global market-access navigator for medical devices and IVDs.
GRZAN is a specialist consultancy for medical device and IVD market access, providing end-to-end regulatory solutions across the product lifecycle and making international market entry simpler and faster.
Key figures. More than 25 wholly owned subsidiaries worldwide covering 50+ countries and regions; chosen by 100+ listed and leading Chinese device manufacturers, with 4,000+ successful cases; 12+ years in the sector and 200+ regulatory training sessions and seminars delivered.
What we do. Global market access: multi-country registration programmes, technical documentation, regulatory advice. Clinical evidence: clinical evaluation reports (CER), usability studies, overseas clinical investigations. Quality systems: ISO 13485, MDSAP, FDA QMSR and BGMP implementation and audit readiness. Authorised representative and licence-holder services across Southeast Asia, Latin America, the Middle East, Africa, Europe and North America.
Why GRZAN. A real operating entity, with the certificate held by the manufacturer: our direct overseas subsidiaries act as the compliant local holder, so the regulatory relationship stays clear and you keep control rather than being tied to a distributor. Direct access to the team: no time-zone gap, no language barrier, no cultural gap. Review points anticipated: we know what FDA 510(k), EU MDR, Southeast Asian, Latin American and Middle Eastern reviewers look for, which shortens timelines and reduces deficiency letters. Pathway planning: pre-decision analysis and risk assessment before you commit.
Every engagement rests on three commitments: efficiency through pre-submission review, certainty through a clear pathway, and stability through a licence-holder that stays in place.
Take your devices global with GRZAN
We work with manufacturers worldwide to open new markets with a clear regulatory pathway.
Contact us