Vietnam Device Rules: Decree 98/2021 and Its Three Amendments

Q: How many instruments make up Vietnam’s device rules today?

A: One parent decree, three amendments and a set of ministerial circulars:

• Parent decree: Decree 98/2021/NĐ-CP (8 November 2021, in force 1 January 2022);
• Amendment one: Decree 07/2023/NĐ-CP (3 March 2023), which amends Article 21(2) (owner of the circulation number), Article 22 (conditions for circulation), Article 32(3)(c) (correction rules) and Article 37(6) (recall), adds a fourteenth clause to Article 38, and introduces the reference-country fast track provisions;
• Amendment two: Decree 96/2023/NĐ-CP (30 December 2023), whose Article 147(8) to (18) rewrite Chapter IV of Decree 98, “Clinical Investigation of Devices”, while clause 19 adds a clinical investigation report certificate requirement to Article 30;
• Amendment three: Decree 04/2025/NĐ-CP (1 January 2025), which amends the transitional provisions in Article 76 and extends the validity of import licences and similar documents to 30 June 2025.

Q: Why must the four decrees be read together?

A: Because the most common error in Chinese-language sources is to cite Decree 98/2021 alone. Three real pitfalls:

1. Citing only Article 32 of the parent decree misses the 07/2023 amendment on the number of correction rounds and the 90-day window;
2. Citing only Article 30 misses the clinical investigation report certificate introduced by 96/2023 (in force 1 January 2026);
3. Citing only Article 76 treats the long-expired transitional arrangements as current rules.

Q: What role do the ministerial circulars play?

A: Circular 05/2022/TT-BYT (1 August 2022) sets the classification rules (16 general rules, with separate rules for IVDs). Circular 44/2025/TT-BYT sets the mandatory LoA template. Ministry of Finance circulars set the official fees: Circular 59/2023/TT-BTC for the standard rates and Circular 64/2025/TT-BTC for the 50% reduction. Decision 2495/QĐ-BYT (4 August 2025) publishes the list of administrative procedures and the level at which each is handled. In short, decrees set the obligations and the route, circulars set the detail and the price.

Q: What does this hierarchy mean in practice?

A: When checking a legal basis, filter first on whether the clause has been amended. Build an internal clause-to-amending-decree register that records the current source text for each frequently used clause (Articles 21, 22, 30, 32, 32a, 34, 37, 39, 40, 41, 48, 62 and 76). The register is built once and shared company-wide, and it removes the conflicts that otherwise arise between sales, regulatory affairs and logistics.

Practical note: the MOH publishes consolidated compilations of its decrees (Consolidated Document) for day-to-day reference. These compilations lag behind, so check the original amending decree before any major filing, particularly for package amendments such as Article 147 of 96/2023, where the consolidated text occasionally omits clauses.

Verification checklist (26 October 2026): (1) the text of Decree 98/2021/NĐ-CP and its Article 76 transitional provisions; (2) Article 1 of Decree 07/2023/NĐ-CP, clause by clause (Articles 21.2, 22, 32.3.c, 37.6 and 38.14); (3) Article 147(8) to (19) of Decree 96/2023/NĐ-CP; (4) Article 1 of Decree 04/2025/NĐ-CP (Article 76(2), (3) and (4)); (5) Circular 05/2022/TT-BYT; (6) Circular 44/2025/TT-BYT; (7) Decision 2495/QĐ-BYT (4 August 2025).