REGISTRATION OF MEDICAL EQUIPMENT

Question:  

Dear Mr/Mrs Attorney, we are seeking legal advice on registration of dietary supplement product which shall be imported to Vietnam. Thank you.

Reponse:

SB Law thank you for giving us the opportunity to provide our legal consulting services for you. With respect to your questions, we would like to advise as follows:

 1. Preliminary Opinions

According to law of Vietnam, acne patch is considered as medical equipment “type A”. Before importing to Vietnam market, product must be registered at Department of Health where company is located.

• Application for registration of product declaration includes:

1. Application form;
2. Medical equipment classification form;
3. ISO 9001:2015 or ISO 13485:2016 of the manufacturer;
4. Authorization Letter of the manufacturer for the import organization to register the product;
5. The certificate of warranty qualification issued by the product owner, except for disposable medical devices defined by the product owner or there are documents proving that the device is not under warranty;
6. Document containing brief description of the medical device in Vietnamese language enclosed with the document containing description of functions and specifications of the medical device issued by the product owner;
7. Standard conformity document announced by owners of medical equipment;
8. The instruction manual;
9. Label of product;
10. The Certificate of Free Sale (CFS) of product.

 2. Scope of works

Preparation of the dossier

• Notifying to Client about application documents required in accordance with Vietnamese law;
• Checking and complete dossier on the basis of document is provided by the Client;
• Drafting required application documents for submission;
• Liaising with Client to discuss the draft application documents;
• Obtaining preliminary comments from the licensing authority on the draft application documents;
• Finalizing application documents for execution.

Licensing procedure

• Submitting the application dossier to the licensing authority on behalf of Client;
• Following with approval progress of the competent authority;
• Keeping Client updated on the developments and additional requirements, if any;
• Receiving and delivering results to Client.

 3. Timing

Preparing the application dossier:

• We anticipate that this phase shall be completed within 05 working days from full receipt of information and document provided by Client;

Submission of application dossier:

• We shall submit application dossier within 02 working days from full receipt of duly signed and sealed application dossier;

Licensing procedure:

• The estimated time for registering product is around 7 - 10 working days upon the submission.

For avoidance of any doubt, in practice, the administrative procedures may take longer than expected since the competent authority must consult relevant ministries before granting the license. In such a case, SB Law shall try our best to accelerate the progress in order to obtain the approvals at the earliest as possible.

Customers can refer to more consultation contents of related issues via the link:

Medicine and cosmetics registration in Vietnam