First, from the point of view of function, the Medical Device Business Registration Certificate and the Medical Device Business License are legal industry access certificates:
According to the risk degree of medical devices, China implements classified management of medical devices. One type of medical devices does not need permission and filing, the second type of medical devices implements filing management, and the third type of medical devices implements licensing management. "Medical device business record certificate" is obtained by the enterprise engaged in the second kind of medical device business to the local municipal food and drug supervision and management department for the record; The "Medical Device Business License" is obtained after the enterprise engaged in the third kind of medical device business applies to the local municipal food and drug supervision and administration department for permission. After obtaining the medical device business record certificate, the enterprise can sell the second class medical devices within the approved scope; After obtaining the business license of medical devices, enterprises can sell the third kind of medical devices within the approved scope.
Two, medical device business registration certificate and medical device business license conditions are different:
The State Administration of Medical Devices requires that enterprises applying for Class III medical device business licenses must use GSP software that meets the quality management standards for medical device business; For enterprises applying for the registration certificate of Class II medical device business enterprise, the State Administration of Medical Devices suggests using GSP software, but it is not mandatory. As far as the materials submitted are concerned, the materials submitted for applying for the business license of Class III medical devices need to include the basic introduction and functional description of the computer information management system, but the materials submitted for obtaining the business record certificate of Class II medical devices are not required.
Three, the medical device business registration certificate and the medical device business license are valid for different periods:
In terms of validity period, the Registration Certificate of Medical Device Business Enterprise has no validity period, while the License of Medical Device Business Enterprise has a validity period of 5 years.
Four, the medical device business record certificate is different from the medical device business license:
According to the contents stated in the certificate, the Medical Device Business License includes the license number, enterprise name, legal representative, person in charge of the enterprise, domicile, business place, business mode, business scope, warehouse address, issuing department, issuing date and validity period. The Medical Device Business Registration Certificate shall specify the number, enterprise name, legal representative, person in charge of the enterprise, domicile, business premises, business mode, business scope, warehouse address, filing department, filing date and other matters.
The application conditions and requirements of medical device business licenses with different qualifications are different, and the required materials and certificates are also different. If you want to know more about qualifications, you can also leave a message or comment directly and ask questions so that we can help you more quickly!
Beijing One Point One Line Consulting Co., Ltd. is a high-quality service provider focusing on enterprise qualification, hoping to bring more convenient, fast and efficient services to the small partners of enterprises in the future. Our service scope includes: handling documents, ICP certificate agency, game filing of the Ministry of Culture, SP certificate agency of the whole network/provincial network, game version number handling, call center agency of the whole network/provincial network, soft trademark patent, declaration of municipal/national high-tech enterprises, business performance license, IDC/ISP/CDN certificate of the whole network/provincial network, ICP annual inspection and Internet publishing license.