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) | UK (MHRA) |
|---|---|---|---|---|---|---|
| Primary law | Decree 98/2021 | Therapeutic Goods Act 1989 | EU MDR 2017/745 | FD&C Act / 21 CFR | Health Products Act | Medical Devices Regulations 2002 / upcoming changes |
| Classification | Type A–D | Class I–III | Class I–IIa–IIb–III | Class I–II–III | Class A–D | Class I–IV |
| Market access | Declaration / Registration | ARTG listing/registration | CE marking (via Notified Body) | 510(k) / De Novo / PMA | Listing / Registration | CE marking via Notified Body / UKCA marking post-Brexit |
| 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) | Limited (Class I) |
| 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) | Yes (Approved Body conformity assessment) |
| QMS requirement | ISO 13485 / MDSAP | ISO 13485 / MDSAP | ISO 13485 | QMS Regulation (21 CFR 820) — QMSR does not mandate ISO 13485 certification but ISO 13485 alignment is strongly encouraged; both QMS approaches are acceptable for FDA compliance. | ISO 13485 / MDSAP | ISO 13485 |
| Local representative | Required (foreign manufacturers) | Required (Sponsor) | Required (Authorised Rep) | Required (US Agent) | Required (Local Reg Agent) | Required (UK Responsible Person) |
| Dossier format | ASEAN CSDT | ARTG dossier | GSPR + Technical File + CER | eSTAR portal (510(k) / PMA via eCopy format) | ASEAN CSDT | Technical File / Design Dossier |
| UDI | Planned | Implemented | Implemented | Implemented | Planned | 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 prepare a complete, standalone CSDT tailored to Vietnamese requirements, reference standards (including relevant TCVN national standards), and the Essential Principles framework, even if the device is already registered in other ASEAN or international 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.