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?
- 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:
Hotline: (+84) 911.233.955 - (024) 6293 8326
Doanh Tri Law Firm is pleased to accompany our Customers!
Bài viết ngày được thực hiện bởi: nguyenthithuytrang
Chức vụ: Giám đốc công ty
Lĩnh vực tư vấn: Dân sự, Hình sự, Doanh nghiệp
Trình độ đào tạo: Thạc sỹ Luật, MBA
Số năm kinh nghiệm thực tế: 10 năm
- APPLICATION FOR REGISTRATION OF CIRCULATION OF PROBIOTICS
- HOW TO RE-ISSUE THE REGISTRATION NUMBER FOR DAMAGED MEDICAL EQUIPMENT?
- PROCEDURES FOR REGISTRATION OF BIO - PRODUCTS IN 2021
- PROCEDURES FOR ISSUING NEW REGISTRATION NUMBER OF FREE SALE OF MEDICAL EQUIPMENT DO NOT YET HAVE RELEVANT NATIONAL TECHNICAL REGULATIONS
- PROCEDURES FOR NEW ISSUANCE OF FREE SALE NUMBER OF MEDICAL EQUIPMENT ALREADY HAVE RESPECTIVE NATIONAL TECHNICAL REGULATIONS
- PROCEDURES FOR ANNOUNING THE ELIGIBILITY TO MANUFACTURE MEDICAL EQUIPMENT FOR THE ENTERPRISE
- MEDICAL CERTIFICATION (HC) FOR FOOD, FOOD ADDITIVES, PROCESSING AIDS; TOOLS, FOOD PACKAGING MATERIALS AND CONTAINERS
- PROCEDURES FOR GRANTING CERTIFICATES OF SATISFACTION OF FOOD SAFETY REQUIREMENTS TO FOOD MANUFACTURERS AND TRADERS UNDER THE AUTHORITY OF THE MINISTRY OF HEALTH
- CERTIFICATE OF FREE SALE (CFS) FOR EXPORTED FOOD PRODUCTS
- HOW TO EXTEND THE CIRCULATION NUMBER OF MEDICAL EQUIPMENT?
- CONSULTING SERVICE FOR THE ANNOUNCEMENT AND CERTIFICATION OF MICROBIOLOGICAL PRODUCTS IN VIETNAM
- THE PROCESS OF CHEMICAL DECLARATION AND REGISTRATION IN VIETNAM
- CONSULTING REGISTRATION OF INSECTICIDAL AND GERMICIDAL CHEMICALS AND PREPARATIONS FOR HOUSEHOLD AND MEDICAL USE IN VIETNAM