Medical Devices

Template for medical device import license

Applying for an import license of medical devices

The medical devices lacking a circulation number requires an import license for the following purposes: 

  1. Scientific research, inspection, testing, trials, quality assessments, or training on the use and repair of medical devices. 
  2. Meeting urgent needs. 
  3. Humanitarian aid, gifts, or donations for medical facilities, as well as for fairs, exhibitions, or product introductions. 
  4. Humanitarian medical examination and treatment activities.
  5. Personal medical treatment purposes, including personal medical devices or devices required for special diagnostic needs of medical facilities. 
  6. Imported used medical devices intended for research and training purposes (not for human use, diagnostics, or treatment).

Application for import license of medical devices

Enterprises importing medical devices in cases requiring an import license must prepare the following documents:

  • A request for an import license
  • A document summarizing the technical description of the medical device in Vietnamese
  • A certificate of meeting the quality management standards of the medical device manufacturing facility
  • In the case of importing for research purposes, there must be a certified copy of the decision approving the research topic and supporting documents.
  • In the case of importing for training purposes, there must be an original copy of the training program and supporting documents.
  • In the case of importing for the purpose of inspection, testing, and quality assessment, there must be a confirmation document from the competent authority performing the inspection, testing, testing, and quality assessment, clearly stating the quantity; In case of import for aid purposes, there must be a copy of the decision approving the receipt of aid from the competent authority and supporting documents.
  • In case of import as a gift to a medical facility, there must be a copy of the document showing the content of the gift and supporting documents.
  • In case of import for humanitarian medical examination and treatment activities, there must be additional supporting documents.
  • In case of import for special diagnostic needs of a medical facility, there must be additional supporting documents.
  • In case of import for personal medical treatment purposes, including specific personal medical equipment, there must be an additional copy of the doctor’s prescription appropriate to the disease of the individual requesting the import;
  • In case of import for use in fairs, exhibitions, displays, or product introductions, there must be additional copies of documents on the program, invitations, and implementation contracts; 
  • In case of import to meet urgent needs the following additional documents are required: .Approval document of competent authority for urgent needs in disease prevention, control, and overcoming consequences of natural disasters and catastrophes and supporting documents

Template for Medical Device Import License

After thoroughly preparing the necessary documents, enterprises looking to import medical devices must submit their application dossier to the Ministry of Health. 

This can be done through the Ministry of Health’s Administrative Procedures Information System (https://dichvucong.moh.gov.vn) or the Electronic Information Portal for Medical Equipment Management (https://dmec.moh.gov.vn/). 

For additional information regarding the application process and associated service fees for obtaining a medical device import license, please visit: https://medgate.vn/en/service-fee-for-applying-for-medical-devices-import-license/

The medical device import license is issued in accordance with Circular 10/2023/TT-BYT. This Circular amends and supplements certain articles from Circular No. 19/2021/TT-BYT, dated November 16, 2021, issued by the Minister of Health. It outlines the requirements for documents and reports related to the implementation of Decree No. 98/2021/ND-CP, dated November 8, 2021, which concerns the management of medical equipment.

Template for medical device import license

 

 

For more information about medical equipment registration services and the process of obtaining medical devices circulation numbers at MEDGATE, please contact our hotline at 098.546.1894 or email us at medgatevn@gmail.com. We are ready to provide guidance on documentation, procedures, and cost estimates for registration, circulation announcements, and advertising of medical devices.