Legal analysis: a class of medical devices for the record the materials required are: a copy of the business license of the enterprise, a copy of the copy of the organization code certificate, legal person ID card, production, quality management personnel education certificate, the main production equipment and testing devices, product risk analysis information, safety risk analysis report, product technical requirements, products in line with the list of national industry standards.
The first class of medical device products for the record and apply for registration of the second and third class of medical device products, the following information should be submitted:
(a) product risk analysis information;
(b) product technical requirements;
(c) product testing reports;
(d) clinical evaluation information;
(e) product Instructions and labeling samples;
(F) and product development, production and quality management system documents;
(VII) to prove that the product is safe, effective and other information required.
Applicants for registration of medical devices, the filer shall be responsible for the authenticity of the information submitted.
Legal basis: "Supervision and Administration of Medical Devices Regulations" Article 22 of the medical device registration certificate 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.