Medical Device Business License is a necessary document for medical device business enterprises. The establishment of second-class medical device trading enterprises shall be filed with the pharmaceutical supervisory and administrative departments of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government; The establishment of Class III medical device trading enterprises shall be examined and approved by the pharmaceutical supervisory and administrative departments of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government, and a License for Medical Device Trading Enterprises shall be issued.
The medical device business license is now post-approved, and the administrative department for industry and commerce will apply for approval after issuing the business license. The validity period of the Medical Device Business Enterprise License is 5 years.
Extended data:
Relevant requirements for medical device business license:
1, the (food) drug supervision and administration departments of all provinces, autonomous regions and municipalities directly under the Central Government or the entrusted (food) drug supervision and administration institutions of cities divided into districts shall conduct on-site verification of the enterprises to be declared in accordance with the acceptance standards of medical device enterprises, and review the application materials in accordance with these Measures.
2, provinces, autonomous regions and municipalities directly under the central government (food) drug supervision and management departments shall, within 30 working days from the date of acceptance, make a decision on whether to issue the "medical device business license".
3. If the application for medical device business license directly involves the significant interest relationship between the applicant and others, the (food) drug supervision and administration department shall inform the applicant and interested parties of the right to apply for a hearing according to law.
Baidu Encyclopedia-Medical Device Business License