HOW TO RENEW MEDICAL EQUIPMENT IMPORT PERMIT

The Ministry of Health issues a license to import medical equipment that is valid for a set amount of time. As a result, if the time limit expires but the importing institution continues to operate in the field of importing medical equipment, it must apply for a license to import medical equipment extension. So, how do you go about renewing your license to import medical equipment?

Legal basis:

- Decree 36/2016/ND-CP on medical equipment management;

- Circular 30/2015/TT-BYT, which governs medical equipment imports.

The license to import medical equipment can be extended only if the medical equipment has already been given an import license.

1. Application for an extension of the license to import medical equipment

- A written request for an extension of the import license from the organization or individual requesting the extension.

- At the time of application submission, the certificate of free sale for imported medical equipment is still valid.

- The power of attorney is still valid at the time of application submission.

- The medical device manufacturer's ISO certificate is still valid at the time of application submission.

- Report on the results of importing medical equipment up to the application for an extension of the license to import medical equipment is submitted.

2. Import permit extension and modification procedures

- Deadline for submitting an application for an import license extension:

+ At least 15 working days before the import permission expires, the Ministry of Health must receive the application file for an extension of the import permit. The time it takes to submit an application is measured from the date on the application receipt that it was submitted.

+ If the importer intends to continue issuing import licenses after this time limit, the importing unit must request a new import license.

- The Ministry of Health is responsible for examining the completeness and legality of the application file for an extension of the import license within 05 working days from the date of receipt.

- The Ministry of Health is responsible for extending the adjustment of the import permit within 10 working days from the date written on the application receipt if the application is complete and legitimate.

- If the importing unit receives a request to amend and supplement the import dossier after sixty (60) days from the date on which the Ministry of Health issues a written notice requesting the modification and supplementation of the import dossier, the importing unit has sixty (60) days from the date on which the Ministry of Health issues a written notice requesting the modification and supplementation of the import dossier. The Ministry of Health will refuse to review the import dossier if the importer does not comply with the request.

The above information is about the "How to renew medical equipment import Permit". For more information and advice on this issue, please contact Doanh Tri Law Firm directly via:

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