International Comparison
Understanding how Vietnam's regulatory framework compares with major international systems helps manufacturers with multi-market strategies plan submissions efficiently.
Side-by-side comparison
| Feature | Vietnam (DAV) | Australia (TGA) | EU (MDR/IVDR) | USA (FDA) | Singapore (HSA) |
|---|---|---|---|---|---|
| Primary law | Decree 98/2021 | Therapeutic Goods Act 1989 | EU MDR 2017/745 | FD&C Act / 21 CFR | Health Products Act |
| Classification | Type A–D | Class I–III | Class I–IIa–IIb–III | Class I–II–III | Class A–D |
| Market access | Declaration / Registration | ARTG listing/registration | CE marking (via Notified Body) | 510(k) / De Novo / PMA | Listing / Registration |
| Pre-market review (low risk) | No (Type A/B self-declared) | No (Class I listing) | Limited (Class I) | Limited (Class I exempt) | No (Class A self-declared) |
| Pre-market review (high risk) | Yes (Type C/D — DAV review) | Yes (TGA evaluation) | Yes (Notified Body conformity assessment) | Yes (FDA 510(k)/PMA review) | Yes (HSA review) |
| QMS requirement | ISO 13485 / MDSAP | ISO 13485 / MDSAP | ISO 13485 | QMS Regulation (21 CFR 820) — ISO 13485 alignment expected but QMSR does not require ISO 13485 certification; both are acceptable. | ISO 13485 / MDSAP |
| Local representative | Required (foreign manufacturers) | Required (Sponsor) | Required (Authorised Rep) | Required (US Agent) | Required (Local Reg Agent) |
| Dossier format | ASEAN CSDT | ARTG dossier | GSPR + Technical File + CER | eSTAR (510k/PMA) | ASEAN CSDT |
| UDI | Planned | Implemented | Implemented | Implemented | Planned |
Using foreign approvals to support Vietnam registration
DAV accepts evidence of foreign regulatory approvals as supporting information within the CSDT — particularly within the clinical evidence and Essential Principles modules. However, a foreign approval alone is not sufficient Manufacturers must still prepare a full CSDT tailored to Vietnamese requirements, reference standards (including TCVN), and the Essential Principles framework, even if the device is already registered in other markets. — it supports but does not replace a complete Vietnam dossier.
Particularly useful foreign evidence:
- CE marking (EU MDR): Robust clinical evaluation standards; CER directly usable
- FDA 510(k)/PMA: Strong technical file; SE determination or PMA approval cited as supporting evidence
- TGA Registration (Australia): ARTG inclusion evidence; Australian clinical evaluation accepted
- HSA Registration (Singapore): Same CSDT format — most modules directly reusable
Multi-market submission strategy
For manufacturers targeting multiple ASEAN markets:
- Prepare your CSDT to the highest standard required by any member state
- Obtain CE marking or FDA clearance first — these generate the most robust evidence base
- Adapt Module 1 (administrative) and Module 10 (labelling) for each country
- Sequence submissions to take advantage of completed review outcomes as supporting evidence
- Ensure your Authorised Representatives in each country are coordinated on concurrent applications
IMDRF harmonisation
Vietnam participates in IMDRF and generally aligns with IMDRF guidance on:
- Software as a Medical Device (SaMD)
- Clinical evidence (MDCE framework)
- Adverse event terminology (IMDRF code system)
- UDI (planned adoption)
IMDRF-aligned submissions are well-positioned for Vietnam as DAV updates its guidance to reflect IMDRF developments.
Either add a UK (MHRA) column to the comparison table with relevant data, or remove the reference to MHRA from the page description. If adding MHRA, include columns for: Primary law (Medical Devices Regulations 2002 / upcoming changes), Classification (Class I-IV), Market access (CE marking via Notified Body / UKCA marking post-Brexit), Pre-market review requirements, QMS requirement, Local representative, Dossier format, and UDI status.
Revise the USA dossier format entry to: 'eSTAR portal (510(k) / PMA via eCopy format)' for clarity.