What are procedures for issuance of export license and import license of medical devices that contain narcotic substances or precursors or raw materials for production thereof in Vietnam?
We almost finish our application for export license and import license of medical devices that contain narcotic substances or precursors or raw materials for production thereof in Vietnam. However, I'm still unclear about the procedures for this process. Thank you!
Hung Phuong - phuong**@gmail.com
What are procedures for issuance of export license and import license of medical devices that contain narcotic substances or precursors or raw materials for production thereof in Vietnam? - image from internet
Pursuant to the Decree 36/2016/ND-CP on medical devices management (amended by Clause 27 Article 1 of the Decree 169/2018/ND-CP) stipulating procedures for issuance of export license and import license of medical devices that contain narcotic substances or precursors or raw materials for production thereof in Vietnam:
a) After receiving the application, the Ministry of Health shall send a receipt note (form No. 06 in Appendix IV hereof) to the applicant;
b) If the application is satisfactory, the Ministry of Health shall process it within 15 working days from the date written on the receipt note. If the application is rejected, a written response and explanation shall be provided.
The Ministry of Health shall process an application for the license to export medical devices or raw materials containing narcotic substances or precursors within 15 working days from the day on which the Ministry of Public Security issues a notice. If the application is rejected, a written response and explanation shall be provided;
The export or import license shall be sent to the applicant and customs authorities. In case of medical devices or raw materials containing narcotic substances or precursors, the export or import license shall also be sent to the Ministry of Public Security and the Ministry of Finance;
A license to export or import medical devices containing narcotic substances and precursors or raw materials for production thereof is only valid for a single export or import and will expire on the date written thereon.
c) If the application is not satisfactory, within 05 working days from the date written on the receipt note, the Ministry of Health shall request the applicant to supplement it. The request shall specify necessary addition of documents or revision of information.
d) The applicant shall comply with the request and send the supplemented application to the Ministry of Health;
If the supplemented application is still unsatisfactory, the Ministry of Health shall request the applicant to supplement it.
dd) If the applicant fails to submit the supplemented application within 60 days, the application will be rejected.
e) If the supplemented application is satisfactory, the Ministry of Health shall issue the import or export license in accordance with Point b of this Clause. The export or import license shall be sent to the applicant and customs authorities
Best regards!
