GRZAN Vietnam Registration Service: Assessment to Post-Market

Q: What can GRZAN do in Vietnam?

A: We cover the full chain from assessment to post-market maintenance, in six modules:

1. Feasibility assessment and classification — determine A/B/C/D under the Circular 05/2022 rules and issue a written classification conclusion with the rule basis; identify whether the expedited pathway (reference-country approval) or priority processing (Decree 96/2023 cases) is available;
2. Holding structure design — compare distributor-held, independent third-party MAH and own company, and recommend one against SKU count and market commitment; identify and verify the Vietnamese MAH (business licence scope, Trading Eligibility Declaration, staff and warehousing, circulation numbers held);
3. Document chain preparation — finalise the LoA on the Circular 44/2025 template; review the CFS and ISO 13485:2016 (IAF accreditation plus scope check); design the notarisation and legalisation chain (deciding between Apostille and consular legalisation under the rules in force from 11 September 2026); arrange Vietnamese notarised translation;
4. Technical dossier preparation — prepare Class C/D dossiers in CSDT format, including the technical description, list of applicable standards, a traceability matrix for the risk analysis, the organisation of clinical evidence, and Vietnamese labelling and instructions for use (compliant with Decree 37/2026: font size of at least 0.9 mm, date format, device-specific items);
5. Filing and deficiency follow-up — submit and track portal status; maintain a deficiency countdown board (90 days / three rounds maximum); require the MAH to commit to forwarding deficiency notices within 24 hours and write that into the service agreement;
6. Post-market and annual maintenance — price declaration before circulation, publication of advertising content on the portal, Trading Eligibility Declaration and changes (3-working-day update), adverse event vigilance and 30-day reporting, recall and change management, ISO 13485 and CFS renewal, and quarterly review of the regulatory register.

Q: How does GRZAN work differently?

A: Three points.

• We do not treat the review timeline as the project timeline — we schedule in three segments, document chain, review and deficiency buffer, with responsibilities fixed for each, avoiding delays that cannot be attributed, such as “waiting for the other side’s documents”;
• We keep control with the manufacturer — we recommend an independent MAH plus multiple distributor authorisations (Article 47(2) of Decree 98), so that a change of channel does not touch the registration certificate; the LoA and import authorisations are finalised jointly by the manufacturer’s regulatory and legal teams;
• We work from the text in force — the whole series answers against the current text with the four decrees layered, and flags expired transitional arrangements (import on a classification document and extension of old import licences, both ending on 30 June 2025), so that clients do not operate on outdated rules.

Q: How do we start?

A: Three steps. (1) Free preliminary assessment — provide the product name, intended use, registration status in the country of origin (whether NMPA, CE or FDA approval is held) and the list of target models. (2) We issue a Vietnam Registration Feasibility Assessment covering the classification conclusion, route selection (declaration, circulation registration or expedited pathway), timeline estimate and cost breakdown. (3) Once the plan is confirmed, the document chain and dossier preparation begin.

Q: Can you guarantee a certificate?

A: We do not promise “guaranteed approval” or “100% issuance”. What we can promise is certainty in the process: the classification conclusion rests on a stated rule basis, the dossier closes item by item against the CSDT, the document chain is right first time, deficiency responses are filed within the deadline, and post-market obligations sit in a register that can be checked. The outcome of Vietnamese review depends on dossier quality and the sufficiency of the product’s own evidence; getting the process right is the only reliable way to improve the odds.

Practical note: before starting a Vietnam project, answer four questions: (1) which class does the product fall into under Circular 05/2022? (2) is there a reference-country approval that allows the expedited pathway? (3) which holding model, and what will it cost to change distributor in three years? (4) working back from the target launch date, does the document chain fit? Answer these four and the project is half done.

Verification checklist (26 October 2026): (1) Decree 98/2021/NĐ-CP and the three amending decrees (07/2023, 96/2023, 04/2025); (2) Circular 05/2022/TT-BYT and Circular 44/2025/TT-BYT; (3) Circular 59/2023/TT-BTC, Circular 64/2025/TT-BTC and MOH Notice 645/TB-HTTB; (4) Decision 2495/QĐ-BYT (4 August 2025); (5) Decree 37/2026/NĐ-CP (23 January 2026); (6) the Hague Apostille Convention in force for Vietnam (11 September 2026).