2025Materials required for new medical device business license application：

Peng Yi Aaron said that the materials required for the new medical device business license in 2025 are the materials required for the medical device business license.：Those engaged in the business of Class III medical devices，The operating enterprise shall submit an application to the local food and drug supervision and administration department at the districted municipal level.，and submit the following information：　　(one)Copy of business license;　　(two)legal representative、Business person in charge、Proof of identity of the quality manager、Copy of academic qualification or professional title certificate;　　(three)Organizational Structure and Department Setup Instructions;　　(Four)Business scope、Description of business methods;　　(five)Business premises、Geographical location map of warehouse address、floor plan、Property ownership certificate or lease agreement(Attached is the property ownership document)a copy;　　(six)Business facilities、Device catalog;　　(seven)Operation quality management system、Work program and other file directories;　　(eight)Basic introduction and function description of computer information management system;　　(Nine)Certificate of authorization of the person in charge;　　(ten)Other supporting materials。

Medical device business license

Process

：Regarding the third-category medical device business license application submitted by the applicant，The food and drug supervision and administration departments at the districted municipal level shall handle the cases separately according to the following situations:：　　(one)The application matters fall within its scope of competence，Complete application information、comply with legal form，Application should be accepted;　　(two)Application materials are incomplete or do not comply with legal forms，The applicant should be notified on the spot or within 5 working days of all the content that needs to be supplemented and corrected.，Failure to notify after the due date，The application will be accepted from the date of receipt of the application materials.;　　(three)There are errors in the application materials that can be corrected on the spot.，Applicants should be allowed to make corrections on the spot;　　(Four)The application matter does not fall within the scope of authority of this department，A decision to reject the application should be made immediately，and inform the applicant to apply to the relevant administrative department。

The food and drug supervision and administration department at the districted municipal level accepts or refuses to accept the application for a medical device business license.，A notice of acceptance or rejection shall be issued。Medical device business license application time limit：The districted municipal food and drug administration department shall review the application materials within 30 working days from the date of acceptance.，and in accordance with the medical device quality management standards

Require

Conduct on-site inspections。

Needs rectification，Rectification time is not included in the review time limit。Meet the prescribed conditions，Make a written decision to grant permission in accordance with the law，And issue a "Medical Device Business License" within 10 working days;Not meeting the prescribed conditions，Make a written decision not to grant permission，and explain the reasons。Related products：2025Materials required for new medical device business license application：

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