1, accepted by the administrative examination and approval service center for preliminary examination;
2, drug evaluation and certification center for technical review;
3, drug market supervision department comprehensive audit, meets the requirements, in charge of the director for examination and approval, the director for examination and approval;
4, the administrative examination and approval service center to inform the applicant, certificate, service "medical device business license" and a copy of the examination and approval opinions.
Processing cycle:
The statutory approval time limit is 30 working days, and the commitment period is 20 working days. The processing period does not include the time required for the applicant to supplement and correct materials, technical review (80 working days), issuance and delivery of license documents (10 working days), and may be extended by 10 working days under special circumstances.
Basis and standard of charges: Notice of Hubei Provincial Price Bureau and Provincial Department of Finance on Cleaning up the Administrative Charges of Printing Drug Supervision System and Related Issues), and the on-site inspection and acceptance fee is 500 yuan/time.
Name of application form and acquisition method:
1, medical device business enterprise license application form
2, the person in charge of the enterprise and quality management personnel table
3, enterprise operating facilities and equipment list
4, the application materials authenticity commitment
For more details, please visit Frida official website!