The three certificates refer to: medical device manufacturer's license, medical device business license, quasi-nominal medical device registration certificate.
Medical device manufacturing license is a medical device manufacturer must hold the documents, issued by the local Drug Administration audit. The opening of medical device manufacturers should be in line with the national medical device industry development plan and industrial policy.
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 and 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 and municipalities directly under the Central People's Government drug supervision and management department for examination and approval, and issued the "Medical Device Business Enterprise License".
Medical device registration, refers to the legal process, the proposed market sales, use of medical devices for systematic evaluation of safety, effectiveness, in order to decide whether to agree to its sale, use of the process.
It is divided into the registration of medical devices within the territory and the registration of medical devices outside the territory, medical devices outside the territory, regardless of Class I, Class II, Class III have to go to the State Food and Drug Administration in Beijing for processing: within the territory of the Class I, Class II medical devices in the local provincial or municipal food and drug administration for processing, Class III to the State Food and Drug Administration to deal with. The medical device registration certificate refers to the legal identity card of the medical machinery products.
/iknow-pic.cdn.bcebos.com/cf1b9d16fdfaaf51866cba18815494eef11f7a8d "target="_blank "title=""class="ikqb_img_alink">/iknow- pic.cdn.bcebos.com/cf1b9d16fdfaaf51866cba18815494eef11f7a8d?x-bce-process=image%2Fresize%2Cm_lfit%2Cw_600%2CCh_800%2Climit_1% 2Fquality%2Cq_85%2Fformat%2Cf_auto "esrc="/cf1b9d16fdfaaf51866cba18815494eef11f7a8d"/>
Expanded Information
According to the "Medical Organization According to the "Regulations on the Management of Medical Institutions", the application for registration of medical institutions, obtaining "medical institutions practice license" should have six conditions:
1, have set up a medical institution approval letter.
2. Meet the basic standards for medical institutions.
3, have a suitable name, organization and premises.
4. There are funds, facilities, equipments and professional health technicians appropriate to the business they carry out.
5. There are appropriate rules and regulations.
6, able to independently assume civil liability.
According to the "physicians, Chinese medicine practitioners, individual practice of the Interim Management Measures," the provisions of the individual practice of physicians, Chinese medicine practitioners by the county (urban) health administrative department issued licenses, supervision and management, and collect management fees.
Individual practitioners, Chinese medicine practitioners must obtain a license to practice before they can open. Individual practitioners, Chinese medicine practitioners should be strictly in accordance with the approved location, diagnostic and therapeutic subjects and scope of business practice, change location, diagnostic and therapeutic subjects, scope of business and clinic name, should be reported to the licensing authority for approval. To foreign provinces, cities and counties to practice, you must go to the regional health administrative department to apply for a license to practice.
References:
References:
Reference: