Medical device manufacturer's license", "medical device registration certificate", "medical device business license" and product qualification certificate and other qualifications.
Inclusion of large medical equipment management items of large medical equipment, should have a health administrative department issued by the configuration of the license.
Expanded information:
A medical device business enterprise must have a medical device license. license.
Opening the second class of medical equipment business enterprises, should be to the provincial, autonomous regions, municipalities directly under the Central People's Government drug supervision and management department for the record; open the third class of medical equipment business enterprises, should be by the provincial, autonomous regions, municipalities directly under the Central People's Government drug supervision and management department for examination and approval, and issued "medical equipment business license.
Medical equipment business license is now a post approval, industrial and commercial administration department issued a business license to apply for approval. Medical Device Business License" is valid for 5 years.
Second, the medical device registration, refers to the legal process, the proposed market sales, use of medical devices, safety and effectiveness of systematic evaluation, in order to decide whether to agree to its sales, use of the process.
It is divided into the registration of medical devices within the territory and the registration of medical devices outside the country, medical devices outside the country, whether it is a class, class II, class III to the State Food and Drug Administration in Beijing.
Domestic class I, II medical devices in the local provincial or municipal food and drug supervision bureau for, class III to the State Food and Drug Administration for. The medical device registration certificate is the legal identity card of the medical device product.
Three, the medical device production license is a medical device manufacturer must hold the documents, issued by the local Food and Drug Administration audit.
Starting a medical device manufacturing enterprise should be in line with the national medical device industry development planning and industrial policy.
Baidu Encyclopedia - Medical Device License
Baidu Encyclopedia - Medical Device Registration Certificate
Baidu Encyclopedia - Medical Device Manufacturing License