The second class of medical devices for the record vouchers are valid for five years, according to the "supervision and management of the production of medical devices" in order to strengthen the supervision and management of the production of medical devices, standardize the production of medical devices, to ensure that medical devices are safe and effective. Has been filed for the record of medical devices, the record of information on the content of the table and the record of changes in product technical requirements, 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 departments should be posted in the record information on the changes. 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 the original registration department to apply for renewal of registration, and in accordance with the relevant requirements for the submission of application information. Has been registered medical devices, its management category from the high category adjusted to the low category, medical device registration certificate in the validity period continues to be valid, the expiry of the validity of the need for continuation, should be in accordance with the adjusted categories of the expiry of 6 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:
"Medical Device Registration and Record Management Measures"
Article XIII of the medical device production license is valid for five years, containing the license number, enterprise name, legal representative, responsible person of the enterprise, domicile, production address, scope of production, the licensing department, the date of issuance of the license and the validity of the period of time And other matters.
Article 84 of the approval of the renewal of registration in the original registration certificate is valid, the continuation of the registration of the validity of the registration certificate for the original registration certificate for the next day after the expiration date; approval of the time is not in the original registration certificate for the continuation of the registration of the registration certificate for the continuation of the validity of the validity of the registration of the approval of the date of the continuation of the registration.