The medical device product qualification certificate is the medical device business license.
Medical equipment business license is a medical device business enterprises must have the documents, the opening of the second class of medical equipment business enterprises, should be to the provinces, autonomous regions, municipalities directly under the Central People's Government drug supervision and management department for the record; the opening of the third class of medical equipment business enterprises, should be by the provinces, autonomous regions, municipalities directly under the Central People's Government drug supervision and management department for examination and approval, and issued the "medical equipment business enterprise license". License".
Medical equipment business license is now a post approval, the industrial and commercial administration department issued a business license to apply for approval. The Medical Device Business License is valid for 5 years.
Expanded Information:
Medical device business license requirements related to the provisions:
1, provinces, autonomous regions, municipalities directly under the Central Government (food) drug supervision and management departments or to accept the entrusted municipal (food) drug supervision and management agencies based on the inspection and acceptance of medical device business enterprise inspection and acceptance of the standards of the proposed business enterprises to carry out on-site verification and in accordance with this Measures to review the application information.
2, provinces, autonomous regions, municipalities directly under the Central (food) drug supervision and management department shall within 30 working days from the date of acceptance to make a decision on whether or not to issue a "medical device business license".
3, "medical device business license" application directly involves the applicant and others with significant interests, (food) drug supervision and management department shall inform the applicant and interested parties the right to apply for a hearing in accordance with the law.
Baidu Encyclopedia-Medical Device Business License