What is the latest form of application for license to import medical devices in Vietnam according to Circular 10/2023/TT-BYT?
What is the latest form of application for license to import medical devices in Vietnam according to Circular 10/2023/TT-BYT?
Pursuant to Form No. 05 of Circular 10/2023/TT-BYT stipulating the latest form of application for license to import medical devices in 2023 as follows:
Download the latest form of application for license to import medical devices in 2023 according to Circular 10/2023/TT-BYT: here
What is the latest form of application for license to import medical devices in Vietnam according to Circular 10/2023/TT-BYT? (Image from the Internet)
What are the cases requiring import license in Vietnam?
Pursuant to the provisions of Clause 1, Article 48 of Decree 98/2021/ND-CP (amended by point a, Clause 12, Article 1 of Decree 07/2023/ND-CP) stipulating cases requiring import license as follows:
- 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 are the procedures for processing an application for license to import medical devices in Vietnam?
Pursuant to Clause 3, Article 48 of Decree 98/2021/ND-CP stipulates as follows:
Import license
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3. Procedures for processing an application for license to import medical devices:
a) 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.
b) 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.
c) 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.
d) 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.
dd) 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.
Accordingly, the consideration of the application for license to import medical devices is done in the same order as the above.
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