Legal analysis: (a), first of all, to the Industrial and Commercial Bureau for a business license, registered as an enterprise, can be a legal person enterprise, unincorporated enterprises, sole proprietorships, partnerships, etc., individual businessmen and women are not allowed to apply for the record certificate. (B), and then to the Quality Supervision Bureau for organization code certificate. (C), and finally to the State Food and Drug Administration website with the organization code to register an account, online reporting. (D), online reporting "medical device filing application form" need to submit electronic materials
Legal basis: "Regulations for the Supervision and Administration of Medical Devices"
Article XIII of the first class of medical devices for the record management of the implementation of the product, the second class, the implementation of the third class of medical devices for the management of the product registration. Medical device registrants, filers should strengthen the quality management of medical devices throughout the life cycle, the development, production, operation, use of the whole process of medical devices, safety and effectiveness of responsibility according to law.
Article XIV of the first class of medical device products for the record and apply for the second class, the 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 reports;
(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 exempt from clinical evaluation of the situation, may be exempt 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.
Article XVI of the application for registration of Class II medical device products, the applicant for registration shall be located in the provinces, autonomous regions and municipalities directly under the Central People's Government of the People's Government of the drug supervision and management department to submit an application for registration information. Apply for registration of Class III medical device products, the applicant shall submit an application for registration to the State Council Drug Administration.
To China's exports of Class II, Class III medical devices outside the applicant for registration, by its designated enterprise legal person in China to the State Council Drug Administration to submit the application for registration and registration of the applicant's country (region) competent authorities to permit the marketing of the medical device supporting documents. Not in the overseas market of innovative medical devices, can not submit the registration applicant's country (region) competent authorities to authorize the marketing of the medical device documents.
The State Council Drug Administration shall make provisions for medical device registration review procedures and requirements, and strengthen the provincial, autonomous regions and municipalities directly under the Central People's Government of the drug supervision and management department of the registration review supervision and guidance.