Is a Class II medical device business filing certificate considered a business license?
Operation of Class I and Class II medical devices need medical device filing certificate, the operation of Class III medical devices need to operate the production license.
Production license production license is valid for four years, six months before the expiration of the original license shall be reapplied for, the production license to implement the annual inspection system. Production license including license number, enterprise name, legal representative, responsible person, enterprise type, registered address, production address, production range, licensing authority, date of issue, validity and other items.
Class II medical devices Class II medical devices means that its safety, effectiveness should be controlled medical devices. x-ray film machine, ultrasound, microscope, biochemical instrument belongs to Class II. Business Class II, Class III medical devices should hold a "medical device business license.
Scope of Application Production License "Application for National Industrial Products Production License" applies to the production license application for enterprises to issue, renew, relocate, add items, etc.. Group companies and their affiliated units together with the license, the group company and its affiliated units to fill out the "Application". Additions include the addition of product units, increase specifications, product upgrades, increase the group company's affiliates, and so on.
What departments are required to record the validity of Class III medical devices for how long?
Three types of medical devices need to submit registration application information to the State Council Drug Administration, medical device registration certificate is valid for five years.
June 1, 2021 came into force "supervision and management of medical devices regulations" Article XIII provides that the first class of medical devices to implement the management of product filing, the second class, the third class of medical devices to implement the management of product registration.
Article 16 provides for the application for registration of Class III medical device products, the applicant for registration shall submit the registration application information to the State Council Drug Administration
Article 22 provides that the registration of medical devices is valid for five years. The expiration of the validity of the need to renew the registration, should be valid for six months before the expiration of the original registration department to apply for renewal of registration.
Certificate of Class II medical devices?
The Class II medical device license is 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. According to the "supervision and management of medical devices regulations" developed by the "supervision and management of medical device production" Article XIII "medical device production license" is valid for five years, set out the license number, enterprise name, legal representative, the person in charge of the enterprise
Two types of device license validity?
Medical device registration certificate is valid for five years, under normal circumstances, Class II medical device registration certificate in the six months before the expiration of the preparation of information submitted to the Drug Administration registration department to apply for a renewal of the registration certificate. Once the registration certificate expires, you can only re-register
Why is the Class II medical device product renewed every four years?
Need, Class II medical device registration certificate is valid for five years (see Article 36), the expiration of the need to renew the registration (see Chapter VII). Class II medical devices are registered, not for the record, a class of medical devices is for the record (see Article V). Measures for the Administration of Registration of Medical Devices (State Food and Drug Administration Decree No. 4) provides that: Article 5 Class I medical devices are managed for the record. Class II and Class III medical devices are subject to registration management. Within the first class of medical devices for the record, the filer to the municipal food and drug supervision and management department to submit filing information. Within the second class of medical devices by the provinces, autonomous regions and municipalities directly under the Central Food and Drug Administration to review and approve the issuance of medical device registration certificate. Within the third class of medical devices by the State Food and Drug Administration for review, approval issued after the medical device registration certificate. Import of Class I medical devices for the record, the filer to the State Food and Drug Administration to submit the record information. Import of Class II and Class III medical devices by the State Food and Drug Administration for examination, approval and issue of medical device registration certificate. Hong Kong, Macao, Taiwan, the registration of medical devices, for the record, with reference to the import of medical devices. Article 36 accepts applications for registration of food and drug supervision and management departments shall make a decision within 20 working days after the end of the technical review. To meet the safety and efficacy requirements, registration is granted, from the date of approval decision within 10 working days to issue a certificate of registration of medical devices, approved product technical requirements in the form of an attachment to the applicant. Not registered, shall state the reasons in writing, and at the same time inform the applicant the right to apply for review and apply for administrative reconsideration or administrative litigation according to law. Medical device registration certificate is valid for five years. Chapter VII renewal of registration Article 54 of the expiration of the certificate of registration of medical devices need to renew the registration, the registrant should be in the medical device registration certificate expires six months before the expiration of the registration, to the food and drug supervision and management departments to apply for renewal of registration, and in accordance with the relevant requirements for the submission of declarations. In addition to the provisions of Article 55 of these measures, the application for renewal of registration received by the food and drug supervision and management department shall be in the medical device registration certificate before the expiration of the validity of the decision to grant the continuation. Late decision, deemed to be allowed to continue. Article 55 of the following circumstances, not to renew the registration: (a) the registrant did not apply for renewal of registration within the prescribed period; (b) the mandatory standards for medical devices have been revised, the medical device can not meet the new requirements; (c) for the treatment of rare diseases and to deal with public **** health emergencies in urgent need of medical devices, the approval of the registration department in the approval of the listing of the requirements of the registrant has not been completed within the prescribed period of medical device registration. In the specified period of time to complete the medical device registration certificate sets out the matters. Article 56 of the acceptance of applications for renewal of registration of medical devices and approval procedures, this chapter does not provide, the relevant provisions of Chapter V of these measures shall apply.