What is the application for a license to import medical devices in Vietnam according to the latest regulations? In what cases is a license to import medical devices required?
- In what cases is a license to import medical devices in Vietnam required?
- What is the application for a license to import medical devices in Vietnam according to the latest regulations?
- What are the procedures for processing an application for a license to import medical devices in Vietnam according to regulations?
In what cases is a license to import medical devices in Vietnam required?
For the cases specified in Clause 1, Article 48 of Decree No. 98/2021/ND-CP (amended and supplemented at Point a, Clause 12, Article 1 of Decree No. 07/2023/ND-CP), a license to import of medical devices is required in the following cases:
- Unregistered medical devices are imported to serve scientific research, testing, inspection, experiment, performance evaluation, or instruction for use or device modification only;
- Unregistered medical devices are imported to serve epidemic prevention and control, or disaster recovery;
- Unregistered medical devices are imported as assistance or humanitarian aid; gifts or presents given to health facilities; or to serve display at trade fair, exhibition or product launch event;
- Unregistered medical devices are imported to serve charitable medical examination and treatment;
- Unregistered medical devices are imported for personal treatment of illness, including personalized medical devices, or to serve a health facility’s special diagnosis demand;
- Unregistered medical devices are imported for use in health facilities with ODA funding and concessional loans or grants other than ODA grants.
What is the application for a license to import medical devices in Vietnam according to the latest regulations? In what cases is a license to import medical devices required?
What is the application for a license to import medical devices in Vietnam according to the latest regulations?
According to Clause 2, Article 48 of Decree No. 98/2021/ND-CP (amended and supplemented in Clause 12, Article 1 of Decree No. 07/2023/ND-CP), an application for a license to import medical devices includes:
(1) The application form for import license;
(2) A synopsis of the technical description of the medical device in Vietnamese;
(3) Certificate of conformity with quality control standards of the manufacturer bearing the applicant’s certification;
(4) If the medical device is imported to serve research: a certified true copy of the decision to approve the research and documents bearing the applicant’s certification proving that the device has been granted marketing authorization by a competent authority;
(5) If the medical device is imported to serve training purposes: the original copy of the training program and documents bearing the applicant’s certification proving that the device has been granted marketing authorization by a competent authority;
(6) If unregistered medical devices are imported for use in health facilities with ODA funding and concessional loans or grants other than ODA grants, the application for import license shall include:
+ The original copies or certified true copies of the decision to approve the investment guidelines and the investment decision for an investment project or the decision to approve project documents for a project on technical assistance, project costs or grants other than ODA grants, in which the import of medical devices must be indicated;
+ The original copy of certified true copy of the contract for supply of medical devices for the project;
+ The power of attorney granted by the product owner to the applicant which must be still valid at the date of application submission. Either the document bearing consular legalization or the certified true copy thereof is accepted;
+ The certificate of eligibility to provide warranty services granted by the product owner, except disposable medical devices defined by product owners or cases where there are documents proving that the medical device is not under warranty. Either the document bearing consular legalization or the certified true copy thereof is accepted;
+ The unexpired CFS (for imported medical devices). Either the document bearing consular legalization or the certified true copy thereof is accepted. If the CFS is made neither in English nor in Vietnamese, it shall be translated into Vietnamese. The Vietnamese translation must be certified as prescribed by law.
(7) If the medical device is imported as aid: a copy of the decision to approve the aid and documents bearing the applicant’s certification proving that the device has been granted marketing authorization by a competent authority;
(9) If the medical device is imported as gift or present given to a health facility: the original copy of the training program and documents bearing the applicant’s certification proving that the device has been granted marketing authorization by a competent authority;
(9) If the medical device is imported to serve charitable medical examination and treatment: documents bearing the applicant’s certification proving that the device has been granted marketing authorization by a competent authority;
(10) If the medical device is imported to serve a health facility’s special diagnosis demand: documents bearing the applicant’s certification proving that the device has been granted marketing authorization by a competent authority;
(11) If the medical device is imported to serve personal treatment of illness, including personalized medical devices: a copy of the physician’s prescription which is consistent with the applicant’s illness;
(12) If the medical device is imported to serve a trade fair, exhibition, display or product launch event: copies of documents on the program, invitation letter and service contract;
(13) If the medical device is imported to serve the purposes of epidemic prevention and control or disaster recovery, the following documents are required:
+ A competent authority’s approval for import of the medical device to serve epidemic prevention and control or disaster recovery;
+ Documents bearing the applicant’s certification proving that the device has been granted marketing authorization or license for emergency use by a competent authority.
What are the procedures for processing an application for a license to import medical devices in Vietnam according to regulations?
Pursuant to Clause 3, Article 28 of Decree No. 98/2021/ND-CP stipulating as follows:
- If the application is satisfactory, the Ministry of Health shall process it within 15 working days, or 02 working days with respect to an unregistered medical device that is imported to serve epidemic prevention and control or disaster recovery, from the receipt of the adequate and valid application (including the application fee receipt as prescribed by the Ministry of Finance).
If an application is refused, a written response indicating reasons for such refusal shall be provided.
The import license shall be sent to the applicant and customs authorities.
- If the application is not satisfactory, the Ministry of Health shall send a request for modification, in which such documents and contents requiring modification must be specified, to the applicant within 10 days, or 02 working days with respect to an unregistered medical device that is imported to serve epidemic prevention and control or disaster recovery, from the receipt of the application.
- The applicant shall comply with the request for modification and send modified documents to the Ministry of Health as requested.
If the modified application is still unsatisfactory, the Ministry of Health shall continue sending another request for modification of the application to the applicant.
- If the applicant fails to provide the modified application within 30 days from the receipt of the Ministry of Health’s request for modification, the application shall be rejected.
- If the modified application is satisfactory, the Ministry of Health shall issue an import license in accordance with Point a of this Clause. The import license shall be sent to the applicant and customs authorities.
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