The epidemic of SARS-CoV-2 is currently becoming more and more complicated, many organizations and individuals have demand to import medical equipment, especially Covid 19 virus test KIT to use for many purposes such as sponsorship, aid, testing or business. Whatever the purpose is, organizations and individuals must apply for an Import Permit of medical equipment before importing into Vietnam.
This following post shall provide necessary information to apply for an Import Permit of Covid-19 virus test KIT for business purpose.
1.Dossier requesting for new issue of import Permit of medical equipment:
- The written request for new issue of medical equipment Import Permit;
- Valid Certificate of free sale of Covid-19 virus test KIT at the time of submission of dossier (CFS);
Currently, Goverment encourages organizations or individuals import Covid-19 virus test KIT for disease control. Thus, in case CFS doesn’t meet all requests, organizations or individuals is allowed to import a number of samples for expertise and test at the quality assessment point unit designated by the Ministry of Health.
- The valid ISO 13485 or ISO 9001 quality systems certification (hereafter referred to as ISO Certification) of the manufacturer at the time of dossier submission.
- The valid Letter of authorization from the owner of Covid-19 virus test KIT to organizations or individuals importing the Covid-19 virus test KIT at the time of dossier submission;
- The technical material describing the Covid-19 virus test KIT in Vietnamese language;
- Catalogue describing the functions and technical parameters of Covid-19 virus test KIT.
- Procedures for new issue of import Permit:
Step 1: Organizations or individuals submit a dossier at National portal and receive the Receipt of dossier (applying for Covid-19 virus test KIT for business purpose).
Step 2: Within 05 working days from the date indicated in the Receipt, the Ministry of Health shall review the completeness and validity of dossier for new issue of Import Permit.
a) In case the dossier is complete and valid: The Ministry of Health shall hold a meeting of its consultation Council for issue of medical equipment Import Permit for review and opinions to the dossier for new issue of Import Permit within 10 working days from the date indicated in the Receipt.
- Where the consultation Council has no requirement for modification or addition of import dossier and agrees to issue the Import Permit, the Ministry of Health shall issue the new import Permit within 10 working days from the date of minutes of meeting of consultation Council or reply in writing in case of disapproval for issue.
- Where the consultation Council requires modification or addition of dossier:
+ Within 05 working days from the date of minutes of consultation Council, the Ministry of Health must give a written notice to the importing unit for modification or addition of importing dossier.
+ Where the importing unit has modified or added the import dossier but improperly with the requirement, the Ministry of Health shall notify the importing unit for further completion of importing dossier.
+ In case of requirement for modification or addition of import dossier but after sixty (60) days after the Ministry of Health gives a written notice of modification or addition of import dossier but the importing unit fails to comply with such requirement, the Ministry of Health shall refuse to further review such dossier.
b) In case the dossier is incompletion or invalidity:
- Within 10 working days from the date recorded on the Receipt, the Ministry of Health shall give a written notice to the importing unit for modification or addition of import dossier.
- Where the importing unit has modified or added the import dossier but improperly with the requirement, the Ministry of Health shall inform the importing unit to further complete the import dossier;
- If there is no more requirement for modification or addition of import dossier, the Ministry of Health shall issue the new Import Permit.
- In case of requirement for modification or addition of import dossier but after sixty (60) days after the Ministry of Health gives a written notice of modification or addition of import dossier but the importing unit fails to comply with such requirement, the Ministry of Health shall refuse to further review such dossier.
- Expertise fee for issue of medical equipment Import Permit: 2.000.000 VND/dossier.
Contact T2H Lawyers for more information.
T2H Law Liability limited company
Head office: G4-4A, Dormitory 708, Lien Ninh, Thanh Tri, Hanoi
Branch office: Floor 4, no.2, 115 Chien Thang Street, Van Quan Ward, Ha Dong District, Hanoi.
Phone: 0242 242 9900 – 0989 656 682
Website: https://t2hlawyers.vn
Email: contact.t2h@t2h.vn – huong.le@t2h.vn
