Vietnam Medical Device Registration

Vietnam Medical Device Registration

1. Regulatory Authority & Framework

Vietnam regulates medical devices under:

• Decree 98/2021/ND-CP – primary medical device regulation
• Decree 07/2023/ND-CP – major amendment (extended transition, simplified dossiers for many devices)
• Supporting circulars (e.g., Circular 05/2022/TT-BYT on CSDT)

Regulatory authority:
Department of Medical Equipment & Construction (DMEC) under the Ministry of Health (MOH).
Registration portal: DMEC Online System.

2. Device Classification (A/B/C/D – ASEAN/GHTF-aligned)

Classification is based on GHTF rules (intended use, invasiveness, duration, active/IVD nature).

Note: Vietnam accepts classification from EU, US, Korea, Japan, Australia for certain fast-track cases.

3. Registration Routes (Post-Decree 07/2023)

3.1 Class A

• Administrative Declaration (Listing)
• Self-assessment + CSDT summary
• Approval usually issued automatically / very fast
• Validity: Indefinite

3.2 Class B, C, D — Two Routes

Route 1 – Full Registration (Standard)

Requires:

• Local Authorized Representative (LAR)
• Full CSDT dossier
• ISO 13485 of manufacturer
• Evidence of safety & performance
• Clinical evaluation (as applicable)

Approval: Registration Certificate (RC)
Validity: 5 years

Route 2 – Fast-Track Registration

Applicable if the device already has approvals from:
EU CE, FDA 510(k)/PMA, Health Canada, TGA Australia, PMDA Japan, MFDS Korea.

Benefits:

• Simplified dossier
• Faster review timeline
• Reduced technical requirements

4. Dossier Requirements (CSDT Format)

Vietnam uses the ASEAN CSDT structure:

Administrative Documents

• Application form
• Power of Attorney (POA)
• Authorization Letter for LAR
• Free Sale Certificate (FSC) / Market Authorization from reference country
• ISO13485 certificate
• Legal manufacturer licence

Technical Documents (per CSDT)

• Device description + intended use
• Design verification and validation
• Biocompatibility
• Electrical safety (IEC 60601 series)
• Software evidence (IEC 62304, cybersecurity documentation)
• Sterilization validation (if applicable)
• Clinical evaluation report (CER)
• Risk analysis (ISO 14971)
• Labeling & IFU compliant with Vietnamese requirements

5. Official Fees & Timelines

Government Fees

• Class A: ~VND 1,000,000 – 2,000,000
• Class B: ~VND 3,000,000
• Class C/D: ~VND 5,000,000

Typical Timelines

• Class A: 1–2 weeks
• Class B: 2–3 months
• Class C/D: 3–6 months (fast-track may be quicker)

Note: Actual timeline strongly depends on dossier quality and DMEC workload.

6. Local Authorized Representative (LAR) – Critical Requirement

Foreign manufacturers must appoint a Vietnam LAR, responsible for:

• Registration submission
• Post-market surveillance (PMS)
• Import licensing
• Adverse event (AE) reporting
• Corrective actions (FSCA)
• Labeling compliance

Vietnam permits multiple LARs, but each registration number belongs to the LAR who applied.

7. Labeling Requirements

Vietnamese regulations require:

• Device name & model
• Manufacturer & LAR details
• Country of origin
• Lot / serial number
• Manufacturing & expiry date (if applicable)
• Storage conditions
• Vietnamese language labeling or stickers
• IFU (Vietnamese required unless exempted)

8. Importation Requirements

After obtaining the Registration Certificate (RC), the LAR must manage:

• Online import license declaration
• HS code conformity
• Shipment documentation
• PMS & traceability records

High-risk devices may require additional documentation during customs clearance.

9. Post-Market Obligations

• AE & incident reporting to MOH
• FSCA / recall management
• Advertising approvals (mandatory for Class C/D)
• Device tracking & distributor records
• Renewal 3–6 months before expiry (if 5-year RC)

10. Notes for Your Device Portfolio (Consulting View)

11. Advantages of Vietnam Registration

• Fast-track available for CE/FDA products
• Class A is indefinite
• No local clinical trials required for most devices
• ASEAN CSDT alignment → easy harmonization with Malaysia, Singapore, Thailand