1, prepare materials: production filing application form, product registration certificate, production license, legal representative identification, manufacturer's business license, organization code certificate, tax registration certificate, medical device production license, production workshop layout drawings, product schematic diagrams, product standards, technical specifications and other related materials;
2, fill out the application form: fill out the application form and manufacturer's seal and signature of the legal representative. p>
2, fill out the application form: fill out a class of medical devices production filing application form, and stamped with the manufacturer's official seal and signature of the legal representative;
3, submit an application: will be prepared to submit the application materials and application forms together to the provincial drug regulatory authorities or the State Drug Administration (hereinafter referred to as the State Drug Administration) for the record procedures;
4, audit and record: Provincial drug regulatory departments or the State Drug Administration to audit the filing of application materials, such as problems found in the need for additional materials or require modification is notified to the manufacturer;
5, the issuance of a certificate of filing: After the audit, the provincial drug regulatory departments or the State Drug Administration to issue a "medical device production certificate for the record";
6, for changes: such as the manufacturer's production license, the layout of the production plant Drawings, product standards, technical specifications, etc. have changed, then you need to re-apply for the record procedures.
A class of medical devices production filing conditions:
1, production license: manufacturers must hold a medical device production license, and the production of medical devices must be within the scope of the license;
2, qualified products: the production of medical devices must comply with the relevant state laws and regulations, standards and technical requirements, and has a high degree of safety and effectiveness;< /p>
3, product registration certificate: the production of medical devices must have obtained a product registration certificate;
4, product standards and technical specifications: the production of medical devices must have the appropriate product standards and technical specifications;
5, the layout of the production plant drawings: the manufacturer's production plant must comply with the relevant national regulations on the quality management of the production of medical devices and Need to provide production workshop layout drawings;
6, manufacturer qualifications: manufacturers must have a legal business license, organization code certificate, tax registration certificate and other relevant qualifications;
7, legal representative identification: the manufacturer's legal representative identification must be complete.
In summary, different medical device filing process may have slight differences, manufacturers need to specifically understand the local regulations and processes.
Legal basis:
"Regulations for the Supervision and Administration of Medical Devices" Article 1
In order to ensure the safety and effectiveness of medical devices, to protect human health and life safety, and to promote the development of the medical device industry, the formulation of these regulations.
Article 2
These regulations shall apply to the development, production, operation and use of medical devices and their supervision and management within the territory of the People's Republic of China*** and the People's Republic of China.