Post submission

Post submission for Medical devices

(Import license/MA code)

Since 2017 and expected to the end of 2022, Vietnam marketing authorization registration procedure will be fully compatible with the ASEAN Agreement. Depending on the risk classification, import or domestic status, and timing of circulation of each product line, Mednovum will advise clients on the procedures for applying for a marketing authorization number or for an import license, or both.

The marketing authorization number or import license is the prerequisites for importing medical devices  into Vietnam and selling those products to the market. The marketing authorization registration procedure usually lasts from months to a year, depending on the level of backlog of the Ministry of Health from time to time. With careful and professional service, we are committed to providing the optimal pathway and expected results.

To apply for an import license and marketing authorization number of medical devices, MedNovum will:

  1. Advise on licensing procedures applicable to each specific product;
  2. Consult the required documentation to be submitted for each type of procedure;
  3. Compile omitted documents, evaluate the validity of provided documents and guide customers to complete dossiers;
  4. Submit and upload dossiers on corresponding platforms of the Ministry of Health and governmental bodies to obtain import license and/or marketing authorization number, depending on each specific case;
  5. Exchange, explain and adjust dossier on behalf of clients according to the request from the Ministry of Health until the procedure is completed and licensed.

Above all, with many years of experience in the field of consulting specifically in this industry, we profoundly understand the rules of grouping and dividing documents, which enable us to provide optimal solution for  different business needs while ensuring highest legal compliance.

For your reference, please find our service fee here.

Tips: A large or long-term ordering package will come up with a significant fee reduction.

You need to consult, receive price quotation. Please contact us immediately via hotline. Consultants will give you the best service.

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