NMPA published two Q&A on orthopedic devices, addressing two frequently asked issues:
Q: How to determine the mechanical performance indicators when submitting the orthopedic product technical requirements (PTR), and what is the basis for determining the mechanical performance?
A: In the PTR for orthopedic devices, the mechanical performance indicators can be objectively judged, and they need to meet the design input, and obtain the static mechanical indicators of the confirmed product functionality and safety requirements. The determination of its indicators is to ensure that the product meets the basic clinical needs. Applicants can draw on the mechanical performance test data from similar products on the market, and combine their own test data to compare the specific requirements of the indicators.
Q: How to submit the biological evaluation data for orthopedic implanted medical devices?
A: For biological tests, corresponding biological test reports should be submitted, and biological tests should be carried out for the specific products. If the biological test report of the raw material is submitted, it shall be demonstrated that the processing procedure from the raw material to the final product does not introduce new biological risks to the product. For the relevant regulations on biological evaluation, applicants can refer to the “Guideline on Medical Devices Biological Evaluation and Review” and industry standard of GB/T 16886.1.
Please visit our Q&A page which includes common issues as following:
- Clinical Trials (Clinical Evaluation Report, Clinical Trial and Overseas Clinical Data)
- Registration (Initial Registration, Renewal, Modification, and Innovation Approval)
- QMS/PMS (Quality Management System, Post Market Surveillance, Overseas Inspection)
- Risk Evaluation
- Device specific questions