1, medical device registration application form;
2, medical device manufacturing enterprise qualification certificate;
3, product technical report;
4, safety risk analysis report;
5. Applicable product standards and descriptions; (It shall be signed and sealed by the testing organization)
6, product performance self-inspection report;
7. A product registration test report issued by a medical device testing institution with inspection qualification; (original)
8. Clinical trial data of medical devices; (For the original text, please refer to Annex 12 of the Measures for the Administration of Registration for specific submission methods).
9. Instructions for medical devices;
10, valid certification document for product quality system review (certification); (original)
1 1. Self-assurance statement on the authenticity of the submitted materials.
Attached:
Appendix 1, application form for medical device registration, copy of product standard and copy of clinical trial data (contents are consistent with data numbers 1, 5 and 8 respectively);
Annex 2, medical device instructions, labels and packaging labels for the record;
Attachment 3, authenticity verification documents;
Appendix 4, Power of Attorney;
Appendix 5. Electronic documents (including: ① registration application form; (2) registered product standards; 3 description; (4) Record Form for Instructions, Labels and Packaging Labels of Medical Devices).
1. Name of administrative licensing item: Issuance of Class II medical device registration certificate.
Two. Contents of administrative license: Class II medical device products.
Three, the legal basis for the establishment of administrative license:
1, Regulations on the Supervision and Administration of Medical Devices (Decree No.276 of the State Council)
2. Measures for the Administration of Medical Device Registration (OrderNo. 16 of the State Food and Drug Administration)
Four. Number and method of administrative license: there is no limit to the number.
Five, the administrative licensing conditions:
1. Registered products have been listed in the Catalogue of Medical Devices (or products that meet the definition of medical devices and are classified as Class II products, except in vitro diagnostic reagents).
2. The applicant shall obtain the qualification certificate of medical device manufacturing enterprise: business license and medical device manufacturing enterprise license, and the products applied for shall be within the production scope approved by the manufacturing enterprise license.
3. The personnel who apply for medical device registration shall be entrusted by the manufacturing enterprise, have corresponding professional knowledge, and be familiar with the laws, regulations, rules and technical requirements of medical device registration management.
4. Medical devices applying for registration shall have applicable product standards, and national standards, industry standards or registered product standards may be adopted, but the registered product standards shall not be lower than the national standards or industry standards.
The registration of the three types of medical devices is slightly different, and the registration items are very complicated, so it is easy to ignore the details. For more information, please visit Ozda Medical Device Consulting Co., Ltd. official website.
Ozda only focuses on the field of medical devices.