The second class of medical devices for the record certificate is valid for five years. The expiration of the validity of the need to continue the registration, should be valid six months before the expiration of the registration department to the original application for renewal of registration. According to the "supervision and management of medical device production approach" to strengthen the supervision and management of medical device production, standardize the production of medical devices, to ensure the safety and effectiveness of medical devices. According to the "supervision and management of medical devices regulations" developed by the "supervision and management of the production of medical devices" Article XIII "Medical Device Manufacturing License" is valid for five years, set out the license number, enterprise name, legal representative, responsible person, residence, production address, production scope, licensing department, date of issuance and validity period and other matters. Has been filed for the record of medical devices, filing information on the content of the table and the filing of the product technical requirements change, the filer should be filed to the original record department to change the record, and submit a description of the changes as well as related documents. Drug supervision and management department shall be changed 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 from 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.
Legal basis
"Registration and Filing of Medical Devices Management Measures"
Article 84 of the renewal of the registration of the approval of the time in the original registration certificate is valid, the renewal of the registration of the registration of the validity of the certificate of validity of the original certificate of expiration of the day following the date of the renewal of the registration; the approval of the time is not in the original certificate of validity of the continuation of the registration of the Registration certificate validity start date for the approval of the date of renewal of registration.