Legislation List
A reference list of the key legislative instruments governing medical devices in Vietnam. All instruments are available in Vietnamese at vbpl.vn and moh.gov.vn.
Always verify the current version
Vietnamese regulatory instruments are frequently amended. This list was accurate at the time of writing but may not reflect the latest amendments. Always verify the current consolidated version through official government sources.
Government Decrees (Nghị định)​
| Instrument | Subject | Effective |
|---|---|---|
| Decree 98/2021/ND-CP | Core regulation on medical device management — classification, declaration, registration, import, manufacture, distribution, post-market | 1 Jan 2022 |
| Decree 03/2023/ND-CP | Amendments to Decree 98/2021 — classification clarifications, transition provisions, procedural updates | Feb 2023 |
| Decree 117/2020/ND-CP | Administrative sanctions in the health sector — applicable penalty framework for device violations | Oct 2020 |
MOH Circulars (Thông tư)​
| Instrument | Subject | Effective |
|---|---|---|
| Circular 14/2020/TT-BYT | Detailed classification rules for medical devices (Type A–D, IVD rules) | 2020 |
| Circular 05/2022/TT-BYT | Procedures for import and export of medical devices, import permit applications | 2022 |
| Circular 29/2022/TT-BYT | Requirements for clinical investigation of medical devices in Vietnam | 2022 |
Primary Legislation​
| Instrument | Subject |
|---|---|
| Law on Pharmacy 2016 (Law No. 105/2016/QH13) | Governs medicines and related products; referenced in Decree 98 for boundary cases |
| Law on Bidding 2023 (Law No. 22/2023/QH15) | Public procurement framework — registration prerequisite for hospital tender eligibility |
| Law on Health Insurance (amended 2014) | Health insurance reimbursement — affects device pricing and procurement strategy |
| Law on Cybersecurity 2018 (Law No. 24/2018/QH14) | Cybersecurity obligations for operators of critical information infrastructure, including healthcare |
| Penal Code 2015 (amended 2017) | Criminal liability for medical device violations causing death or serious harm |
ASEAN & International Reference Documents​
| Document | Subject |
|---|---|
| ASEAN Medical Device Directive (AMDD) | ASEAN harmonised framework — classification, CSDT, Essential Principles |
| ASEAN Common Submission Dossier Template (CSDT) | Standard dossier format accepted by Vietnam (Type C/D applications) |
| IMDRF N12 | SaMD definition and framework |
| IMDRF N23 | SaMD clinical evaluation |
| IMDRF N41 | SaMD clinical evidence |
| IMDRF N47 | Principles of adverse event reporting harmonisation |
| IMDRF N60 | Cybersecurity for medical devices |
| ISO 13485:2016 | Quality management systems — medical devices |
| ISO 14971:2019 | Risk management for medical devices |
Official Sources​
- Vietnam Legal Document Portal: vbpl.vn
- Ministry of Health: moh.gov.vn
- Drug Administration of Vietnam: dav.gov.vn
- National Medical Device Information System (DMEC): dmec.gov.vn