Can Products Made From Materials Conforming To YY 0341.1 Appendix B Be Exempted From Biological Evaluation?

YY 0341.1-2020 Passive Surgical Implants–Bone and Spinal Implants Part 1: Special Requirements for Bone Implants (Appendix B: Relevant Material Standards Acceptable with Clinical Use Proof)
Biological evaluation cannot be exempted but can be simplified or waived through equivalence comparison, demonstrating that the device under application has the same biocompatibility as marketed products. Materials conforming to YY 0341.1 Appendix B, although clinically acceptable, still require equivalence comparison to ensure the production process does not introduce new biological risks. This includes comparing the production process, such as processing, sterilization, and packaging, to ensure no new harmful substances are introduced. If the production process does not introduce new biological risks upon evaluation, biological testing can be waived.

Dental Implant (System) Registration Technical Review Guidelines (2016 Revision)
According to international conventions, dental implants (systems) made of titanium or titanium alloy materials that comply with GB/T 13810 Surgical Implants–Wrought Titanium and Titanium Alloy for Surgical Implant Applications or the US ASTM series standards, and whose surfaces have not undergone modification or only sandblasting, can apply for exemption from biocompatibility testing but must submit a biocompatibility evaluation report.