Medical devices have been filed, filing information on the content of the table and the filing of the technical requirements of the product changes, the filing should be filed to the original filing department to change the record, and submit a description of the changes as well as related documents. Pharmaceutical supervision and management department shall register the changes in the filing information. The expiration of the validity of the need to continue the registration, the registrant should be in the medical device registration certificate expires six months before, to the original registration department to apply for renewal of registration, and in accordance with the relevant requirements for the submission of application information.
Registered medical devices, the management of the category by the high category adjusted to the low category, the medical device registration certificate in the validity period continues to be valid, the expiry of the validity of the need for continuation, it should be in accordance with the adjusted categories of the validity of the expiry of six months before the corresponding drug supervision and management department to apply for renewal of registration or for the record. Medical device management category from the low category adjustment to the high category, the registrant should be in accordance with the changed category to the appropriate drug supervision and management department to apply for registration. State Drug Administration in the management of the category adjustment notice should be made to complete the adjustment of the time limit.
I. Definition of Class II Medical Devices
Class II medical device means that its safety and effectiveness should be controlled medical devices. Including X-ray film machine, ultrasound, microscope, biochemistry, etc. are classified as Class II medical devices.
Second, the opening of the second class of medical equipment manufacturers must have the following conditions
1, the person in charge of the enterprise should have secondary education or above, or junior title.
2, the person in charge of the quality inspection organization should have college education or above, or intermediate or above title.
3, the enterprise should occupy the corresponding proportion of the total number of employees above junior title engineers and technicians.
4, the enterprise should have the appropriate product quality inspection capabilities.
5, there should be with the production of products and scale of production, storage space and environment.
6, with the appropriate production equipment.
7, the enterprise should collect and save and enterprise production, business-related laws, regulations, rules and relevant technical standards.
8, the production of sterile medical devices, should have a production site in line with the regulations.
Three, the second class of medical equipment record vouchers for the process
1, the first step: upload the electronic version of the material online: log on to the website of the State Drug Administration - Services - Online Office Guide -Medical device production and operation license filing - apply for enterprise - first use registration - registration is complete! After the registration is completed, fill in the application form according to the requirements - upload electronic materials. Upload successfully, waiting for the City Council audit.
2. Step 2: Log in to the system to see if the city council audit. After the audit, you can submit paper materials to the municipal administrative services hall, the municipal office window on-site license.
Legal basis
"Medical Device Registration and Record Management Measures"
Article 84 of the renewal of the registration of the approval of the time in the original registration certificate is valid, the continuation of the registration of the registration of the validity of the certificate of the original expiration of the day following the date of the renewal of the registration certificate; the approval of the time is not in the original registration certificate validity of the registration of the continuation of the registration of the Registration certificate validity start date for the approval of the date of renewal of registration.