Legal analysis: the list of materials required to apply for three types of medical devices: (a) business license, organization code certificate copy; (b) the applicant company holds a copy of the registration certificate of the production of medical devices and product technical requirements; (c) legal representative, the person in charge of the enterprise a copy of the identity; (d) production, quality and technical personnel in charge of the identity of the person, academic qualifications, professional title certificate copy; (e) (E) production management, quality inspection positions employees list of academic qualifications, titles; (F) the production site documents, there are special production environmental requirements should also be submitted to the facilities, environment, a copy of the documents; (G) the main production equipment and inspection equipment directory; (H) quality manuals and procedural documents; (Ix) process flow diagram; (J) the operator's authorization; (K) other supporting information.
Legal basis: "Regulations for the Supervision and Administration of Medical Devices"
Article VI of the State of medical devices in accordance with the degree of risk of the implementation of classification management.
The first category is a low degree of risk, the implementation of routine management can ensure the safety and effectiveness of medical devices.
The second category is a moderate risk, need to strictly control the management to ensure the safety and effectiveness of medical devices.
The third category is a high risk, need to take special measures to strictly control the management to ensure the safety and effectiveness of medical devices.
Evaluating the degree of risk of medical devices, should take into account the intended purpose of the medical device, structural features, use and other factors.
The drug supervision and management department of the state council is responsible for formulating the classification rules and classification directory of medical devices, and according to the production, operation and use of medical devices, timely analysis and evaluation of the changes in the risk of medical devices, and adjust the classification rules and classification directory. The development and adjustment of classification rules and classification directory, should fully listen to the medical device registrant, filer, production and operation of enterprises, as well as the use of units, industry organizations, and reference to international medical device classification practice. Medical device classification rules and classification directory shall be published to the public.
Article XIV of the first class of medical device products for the record and apply for the second and third class of medical device product registration, the following information shall be submitted:
(a) product risk analysis information;
(b) product technical requirements;
(c) product inspection report;
(d) clinical evaluation information;
(e) Product instructions and labeling samples;
(F) and product development, production and quality management system documents;
(G) to prove that the product is safe, effective and other information required.
The product inspection report shall meet the requirements of the State Council drug supervision and management department, can be the applicant for registration of medical devices, the filer of the self-inspection report, or commissioned by a qualified medical device inspection agency issued the inspection report.
Conforms to the provisions of Article 24 of the Regulations exempted from clinical evaluation of the situation, may be exempted from submitting clinical evaluation information.
Applicants for registration of medical devices, the filer shall ensure that the information submitted is legal, true, accurate, complete and traceable.