I. Proof of enterprise qualification
1. Business license: to prove the qualification of the enterprise to operate legally.
2. Production license (if applicable): for production-oriented enterprises, to prove that it has the qualification to produce medical devices.
Second, the product technical documents
1. Product manual: a detailed description of the product's structure, function, use and so on.
2. Technical specifications: provide detailed technical parameters and performance indicators of the product.
3. Safety evaluation report: to assess the safety of the product, including biocompatibility, electromagnetic compatibility and other aspects of the test report.
Three, the quality management system documents
1. Quality manual: outlining the enterprise's quality management system, organizational structure, duties and responsibilities.
2. Procedure documents: detailed provisions of the quality management system of the various aspects of the operational process.
3. Record form: record all kinds of data and information during the operation of the quality management system.
In addition, it is also necessary to provide other documents related to the product, such as registration certificates, clinical trial reports and so on. The specific requirements for these materials may vary depending on national or regional regulations, so you should refer to the relevant local regulations when preparing the materials.
When submitting the filing application, the above materials need to be organized according to the requirements and submitted to the appropriate regulatory agencies for review. After passing the review, the enterprise will obtain the Class II medical device filing certificate, so as to legally carry out the production and sales activities of the relevant products.
In summary:
The filing of Class II medical devices requires the preparation of proof of enterprise qualifications, product technical documents, quality management system documents and other related materials, and submit them to the regulatory body for review in accordance with local regulations. After passing the review, the enterprise will obtain the filing certificate and legally carry out the sales activities of the relevant products.
Legal basis:
Regulations on the Supervision and Administration of Medical Devices
Article 8 states:
The state implements classified management of medical devices in accordance with the degree of risk. To meet the conditions set out in these Regulations, permission is granted and issued to the medical device registration certificate, medical device manufacturing license, medical device business license; do not meet the conditions set out in the permit and a written explanation of the reasons.
"Measures for the Administration of Medical Device Registration"
Article 22 provides:
Application for registration or for the record of imported medical devices, should be in the applicant's location to apply for registration or filing. Among them, the import of Class III medical devices by the State Food and Drug Administration for review, approval issued after the registration of medical devices; imports of Class II medical devices by the provinces, autonomous regions and municipalities directly under the Central People's Government of the food and drug supervision and management department for review, approval issued after the registration of medical devices; imports of Class I medical devices for the record work in accordance with the provisions of the State Food and Drug Administration.
"Supervision and Management of Medical Device Production"
Article 7 provides:
To engage in the production of medical devices, shall have the following conditions: (a) with the production of medical devices and the production of appropriate production sites, environmental conditions, production equipment, and professional and technical personnel; (b) there is the production of medical devices to carry out quality testing of the organization or full-time inspection personnel and Inspection equipment; (C) have to ensure that the quality of medical devices management system; (D) with the production of medical devices compatible with the after-sales service capacity; (E) in line with the product development, production process documentation requirements.