- 1️⃣ Authorized Representative in Vietnam for Medical Devices
- 2️⃣ Medical Device Import License in Vietnam – After Registration
- 3️⃣ Medical Device Classification A B C D in Vietnam
- 4️⃣ Why Medical Device Dossiers Get Rejected in Vietnam
- 5️⃣ Checklist for Foreign Manufacturers Registering Medical Devices in Vietnam
Are you a foreign manufacturer planning to register medical devices in Vietnam? I’m Lucas Do, regulatory and logistics consultant specializing in medical device registration, authorized representative services, and import licensing in Vietnam. Contact me for a free initial consultation.
Vietnam is one of the fastest-growing medical device markets in Southeast Asia. However, foreign manufacturers cannot import, distribute, or sell medical devices in Vietnam without completing the mandatory registration process in accordance with Decree 98/2021/ND-CP (as amended by Decree 07/2023/ND-CP).
This guide explains exactly how to register medical devices in Vietnam, the documents required, timelines, classification rules, and the critical role of a Vietnamese Authorized Representative.
Who Must Register Medical Devices in Vietnam?
Any foreign manufacturer intending to:
- Import medical devices into Vietnam
- Appoint a local distributor
- Supply hospitals, clinics, or laboratories
must complete product registration through a licensed Vietnamese Authorized Representative. Direct submission by an overseas manufacturer is not permitted.
Medical Device Classification in Vietnam (Class A, B, C, D)
Vietnam classifies medical devices into four risk categories. Correct classification is crucial because misclassification is the most common reason dossiers are rejected.
ClassRisk LevelRegulatory Path
A: Low Declaration of applicable standards
B: Low–Medium Registration required
C: Medium–High Registration required
D: High Registration required
Classes B, C, and D require a formal registration dossier and approval number before importation.
Required Documents for Medical Device Registration
A typical dossier includes:
- ISO 13485 certificate of the manufacturer
- Free Sale Certificate (CFS)
- Letter of Authorization for the Vietnamese representative
- Product catalog and detailed technical description
- Label and Instructions for Use (IFU)
- Business license of the Vietnamese Authorized Representative
- Classification result issued by a qualified body
Incomplete or inconsistent documentation often leads to multiple rounds of clarification from the authority.
Actual timelines depend heavily on dossier quality and how feedback from the reviewing officer is handled.
ClassEstimated Timeline
A 3–7 working days
B 30–45 working days
C/D 60–90 working days
Poorly prepared dossiers can extend these timelines significantly due to repeated feedback cycles.
The Role of the Authorized Representative in Vietnam
Foreign manufacturers must appoint a Vietnamese Authorized Representative who is responsible for:
- Submitting and tracking the registration dossier
- Responding to authority feedback
- Maintaining post-market compliance
- Supporting import licensing and customs clearance
An experienced representative can substantially reduce approval time and prevent costly delays.
Common Reasons Medical Device Dossiers Are Rejected
- Incorrect device classification
- Technical description not aligned with the catalog/IFU
- Improper Letter of Authorization format
- Inconsistent product information across documents
- Inadequate responses to authority feedback
Many dossiers become stuck after the third round of feedback due to failure to address the core regulatory concern.
After Approval: Importation and Distribution
Once the registration number is granted, the device can be:
- Imported into Vietnam
- Distributed through licensed channels
- Supplied to healthcare facilities
At this stage, coordination between regulatory approval, import procedures, and logistics becomes essential to avoid customs delays.
How We Support Foreign Manufacturers Entering Vietnam
We provide a complete, integrated solution:
- Medical device registration for Classes A, B, C, D
- Authorized Representative service in Vietnam
- Import licensing and customs clearance
- Logistics coordination for medical devices
- Handling complex dossiers with multiple rounds of feedback
Planning to Enter the Vietnamese Market? If you are preparing to register or import medical devices into Vietnam, request our dossier checklist to ensure your documentation is correct from the start and avoid unnecessary delays.
Need Help With Your Vietnam Medical Device Registration?
I’m Lucas Do – Regulatory & Market Entry Consultant.
Services: Authorized Representative, Dossier Preparation, Import Licensing, Customs Clearance.
Zalo / WhatsApp / WeChat: +84 0988.281.467
Email: sondx@airseaglobalgroup.com.vn