Low risk, medium risk, high risk
The first category is a low risk, the implementation of routine management can ensure the safety and effectiveness of medical devices. The second category is a moderate risk, need to strictly control the management to ensure the safety and effectiveness of medical devices. The third category is a high risk, need to take special measures to strictly control the management to ensure its safety, effective medical devices.
The first class of medical device products for the record, by the filer to the local municipal people's government food and drug supervision and management department to submit the record information. Apply for Class II medical device product registration, the applicant for registration shall be the location of the provincial, autonomous regions, municipalities directly under the Central People's Government of the food and drug administration department to submit the registration application information. Apply for Class III medical device product registration, the applicant shall submit to the State Council Food and Drug Administration registration application information.
Extended information:
Medical device category I, II and III requirements stipulate that:
1, the acceptance of the application for registration of food and drug supervision and management department shall, within three working days from the date of acceptance of the application for registration information will be forwarded to the technical review body. Technical review body should be completed after the technical review to the food and drug supervision and management department to submit the review comments.
2, has been registered Class II, Class III medical device products, its design, raw materials, production processes, scope of application, methods of use and other substantive changes that may affect the safety and effectiveness of the medical device, the registrant shall apply to the original registration department to apply for a change in registration procedures; non-substantive changes that do not affect the safety and effectiveness of the medical device should be the changes to the original Registration department for the record.
3, medical device registration certificate is valid for 5 years. The expiration of the validity of the need to renew the registration, should be valid six months before the expiration of the original registration department to apply for renewal of registration.
Baidu Encyclopedia - Medical Devices Supervision and Administration Regulations