Application materials for extension of registration certificate of medical devices of category III:
1, application form
2. Written proof
The registrant shall submit a copy of the enterprise business license and a copy of the organization code certificate.
3. A statement that the product has not changed.
The registrant provides a statement that the product has not changed.
4, a copy of the original medical device registration certificate and its attachments, copies of previous medical device registration change documents.
5. Product analysis report within the validity period of the registration certificate
(1) product clinical application, user complaints and measures taken.
(2) Summary, analysis and evaluation report on adverse events of medical devices. The report shall include a list of suspicious adverse events that occurred after the product went on the market, and explain the treatment measures and solutions adopted by the production enterprise in each case. Analyze and evaluate the above adverse events, clarify the causes of adverse events, and explain their safety and effectiveness.
(3) Product market description.
(4) Product supervision and sampling (if any).
(5) If there is a recall after listing, the reason, process and result of the recall shall be explained.
(6) If the original medical device registration certificate states that it is necessary to continue to complete the work, it shall provide relevant summary reports and attach corresponding materials.
Regulations on the Implementation of the Drug Administration Law of People's Republic of China (PRC)
Article 42
Non-drugs may not publicize the prevention, treatment, diagnosis and other related contents of human diseases in their packaging, labels, instructions and related publicity materials; However, unless otherwise provided by laws and administrative regulations.