If you are a foreign manufacturer planning medical device registration in Vietnam, the first legal requirement is not the dossier. It is the appointment of a compliant Authorized Representative in Vietnam under Nghị định 98/2021/NĐ-CP (amended by Nghị định 07/2023/NĐ-CP).
Without a valid Authorized Representative, you cannot submit registration, respond to authority feedback, or complete import procedures.
What is an Authorized Representative in Vietnam?
An Authorized Representative (AR) is a Vietnam-licensed entity legally appointed by the foreign manufacturer to:
- Submit medical device registration dossiers
- Work directly with the Ministry of Health during appraisal
- Receive and respond to official feedback
- Maintain post-market compliance
- Support import licensing and customs clearance
Overseas manufacturers are not permitted to submit dossiers directly.
Why most dossiers fail because of the AR (not the documents)
In practice, rejections rarely happen because a document is missing. They happen because:
- Device classification is incorrect (A/B/C/D)
- Technical description does not align with catalog/IFU
- The Letter of Authorization is drafted incorrectly
- Authority questions are answered without regulatory context
- Responses are slow or inconsistent
All of the above are functions of the Authorized Representative’s experience.
Legal responsibilities of the Authorized Representative
Your AR is not a “paper agent”. Under Vietnamese law, the AR is jointly responsible for:
- Accuracy of the submitted dossier
- Product information consistency
- Post-approval compliance
- Coordination with importers and customs
Choosing the wrong AR creates long approval cycles and customs delays later.
What a competent AR actually does for you
A capable Authorized Representative will:
- Review and correct device classification before submission
- Pre-check the full dossier for consistency (ISO, CFS, catalog, IFU, labels)
- Draft compliant authorization documents
- Handle multiple feedback rounds with the authority efficiently
- Synchronize registration approval with import licensing and logistics
This is what shortens approval from months to weeks.
How to evaluate an Authorized Representative in Vietnam
Before appointing, ask:
- Do they understand medical device classification in practice?
- Can they show cases of handling authority feedback rounds?
- Do they also handle import licensing and customs?
- Do they review your dossier before submission, or just forward it?
If the AR only “submits documents”, you will face delays.
The practical outcome
With the right Authorized Representative in Vietnam:
- Registration is approved faster
- Feedback rounds are minimized
- Import procedures run smoothly after approval
- Your distributor can start selling without regulatory bottlenecks
Need an Authorized Representative for Vietnam?
If you are preparing for medical device registration in Vietnam and need a compliant Authorized Representative who also supports import licensing and customs clearance, you can contact:
Lucas Do – Vietnam Regulatory & Logistics Consultant
WhatsApp | Zalo | WeChat: +84 0988.281.467
Email: sondx@airseaglobal.com.vn
You can also read the complete guide here:
Medical Device Registration in Vietnam for Foreign Manufacturers