When it comes to medical device business licenses, everyone only knows that there is such a qualification certificate, but the specific classification is not very clear. Let’s take a look at the second category with you in detail. What is the difference between the medical device business license and the third category? Friends who are not sure which qualification to apply for, hurry up and take a look! 1. In terms of function, the medical device business registration certificate and the medical device business license are both It is a legal industry access certificate: Our country implements classified management of medical device operations according to the risk level of medical devices. Operating first-class medical devices does not require licensing and filing, operating second-class medical devices is subject to filing management, and operating third-class medical devices Devices are subject to licensing management. The medical device business registration certificate is obtained by an enterprise engaged in the operation of Category II medical devices by filing with the local municipal food and drug supervision and administration department; the medical device business license is obtained by an enterprise engaged in the operation of Category III medical devices by filing with the local municipal food and drug administration department. Permit application obtained. After obtaining the medical device business registration certificate, the company can sell Class II medical devices within the approved scope; after obtaining the medical device business license, the company can sell Class III medical devices within the approved scope.

2. There are differences between the medical device business registration certificate and the medical device business license application conditions: The State Food and Drug Administration requires that companies applying for a third-category medical device business license must use medical device business quality certificates GSP software with standardized management; for companies that apply for Class II medical device business registration certificates, the State Food and Drug Administration recommends the use of GSP software, but it is not a mandatory requirement. In terms of the materials submitted, the materials submitted to apply for a Class III medical device business license need to include a basic introduction and functional description of the computer information management system, while the materials submitted to obtain a Class II medical device business registration certificate do not. .

3. There is a difference in the validity period between the medical device business registration certificate and the medical device business license: In terms of validity period, the medical device business registration certificate does not have a specified validity period, while the validity period of the medical device business license is 5 years.

4. There are differences between the contents stated on the medical device business registration certificate and the medical device business license: From the content stated on the certificate, the medical device business license states the license number, enterprise Name, legal representative, person in charge of the enterprise, residence, business place, business method, business scope, warehouse address, certification department, date of certification and validity period, etc.; the medical device business registration certificate states the serial number, company name, statutory Representative, person in charge of the enterprise, residence, business place, business method, business scope, warehouse address, filing department, filing date, etc. The application conditions, application requirements, and required materials and certificates for different qualification categories of medical device business licenses are different. If you want to know more about qualification-related license processing, you can also directly leave a message or comment to make inquiries. So that we can help you faster! Beijing One Point One Line Consulting Co., Ltd. is a high-quality service provider that specializes in corporate qualifications. We hope to bring more convenience and speed to all corporate partners in the future. Efficient service. Our service scope: Internet document processing, ICP certificate agency, Ministry of Culture game registration, network/provincial network SP license agency, game version number processing, network/provincial network call center agency, software trademark patent, city/national High-tech enterprise declaration, radio and television program production and operation license, commercial performance license, application for full network/provincial network IDC/ISP/CDN certificate, application for ICP annual inspection, application for Internet publishing license, Internet drug information services, etc.