The application conditions for Class III medical device license include: 1, there must be a business premises and warehouse matching the scope of business, and there are requirements for its specific area; 2, there needs to be a nationally recognized, and business products related to the professional on duty; 3, there must be a secondary school education or above, and the business products related to the technical staff; 4, there should be a medical device with the operation of a quality management system. In addition, the registrant or filer of the medical device is required to fulfill the obligations including the establishment of a quality management system, the development of risk control plans, and the conduct of adverse event monitoring. For Class II medical device operators, they need to file with the local food and drug regulatory authorities and submit information including filing forms, copies of business licenses, ID cards and academic certificates of relevant personnel.
Medical device registration process:
1, to determine the classification of medical devices: according to the risk level of medical devices, will be divided into Class I, Class II and Class III;
2, to prepare the application for registration of materials: including product specifications, instructions for use, production processes, quality standards, clinical evaluation data;
3, to submit an application for registration: submit an application for registration to the corresponding The drug supervision and management department to submit an application for registration, and pay the appropriate registration fees;
4, technical review: the drug supervision and management department of the materials submitted for technical review, to ensure that the product meets the national standards and requirements;
5, the administrative approval: after passing the technical review, enter the administrative approval stage, and ultimately obtain the certificate of registration of medical devices.
In summary, medical devices are divided into three classes, of which the operating license application conditions for Class III medical devices are the most stringent, requiring matching premises and warehouses, professional on-staff personnel, technical staff and quality management system, while the registrant or the filer is also required to establish a quality management system, etc.; in contrast, the operation of Class II medical devices only need to be filed with the regulatory authorities and submit relevant information.
Legal basis:
"Regulations for the Supervision and Administration of Medical Devices"
Article 11
Application for registration of Class II medical device products, the applicant for registration shall be to the location of the provincial, autonomous regions, municipalities directly under the Central People's Government of the food and drug supervision and management department to submit an application for registration information. Apply for registration of Class III medical device products, the applicant shall submit the registration application information to the State Council Food and Drug Administration. To China's exports of Class II, Class III medical devices overseas manufacturers, should be set up in China's territory by its representative body or designated in China as an agent of the enterprise legal person, to the State Council Food and Drug Administration to submit the application for registration information and registration of the applicant's country (region) competent authorities to permit the marketing of the medical device documents. Class II, Class III medical device product registration application information in the product inspection report should be a medical device inspection agency issued the inspection report; clinical evaluation information should include clinical trial report, but in accordance with the provisions of Article 17 of the Regulations are exempted from clinical trials of medical devices.