Monthly Opinions on Device Registration covers preclinical, clinical and registration issues in medical device and IVD in China. It is published by CFDA and edited by China Med Device, LLC (www.ChinaMedDevice.com) a consulting firm specializing in China CFDA regulatory, CRO and market access services.
Q: Is foreign biocompatibility test recognizable when registering in China?
A: The biological test report issued by a foreign laboratory should be accompanied by a quality assurance document issued by a foreign laboratory indicating that it meets the GLP requirements. If the relevant technical requirements (such as GB/T 16886/ISO 10993 series standards) are met, they can be submitted as biological test materials supporting the biological evaluation of medical devices.
Q: How to subclassify the rib plate registration unit?
A: The rib plate is intended for internal fixation or deformity correction of rib fractures. The rib plate and the limb plate belong to different registration units. They should be subclassified into different units if the materials are different. According to the metal materials commonly used for rib plates, they can be classified into TA3 pure titanium, Ti6Al7Nb titanium alloy, nickel titanium alloy, etc.
Q: Is mouse embryo assay necessary for assisted reproductive consumables (except for in vitro assisted reproductive fluids) after biocompatibility test?
A: Yes. The in vitro assisted reproductive consumables (except for in vitro assisted reproductive fluids) are for gametes, zygotes and embryonic cells at different developmental stages. In addition to routine biocompatibility test, mouse embryo assay should also be conducted referring to YY/T1434-2016.
Q: How to subclassify the Foley anchor registration units?
A: The Foley anchor is intended for the fixation between bone and soft tissue, consisting of sutures and anchors. The composition of the anchor (including the material grade) is different and should be divided into different registration units. The stitching materials used in combination with them are different and should be divided into different registration units. If the declared product consists of multiple stitches or one stitch is made of multiple materials, the materials can be registered as a single registration unit.
Q: What are the main endpoints for clinical trial of peripheral endovascular stent?
A: For peripheral endovascular stent products, the main study endpoints currently used in clinical trials are generally recommended for a 12-month target patency rate.
Q: The combination device can be clinical exempted if all the comprised devices are exempted?
A: If the applicant can prove that the combination of the two does not interact with each other and the clinical use does not exceed the scope of the exemption list, the modules can be evaluated separately. The applicant is required to evaluate the risks associated with the combination.
Q: What should I pay attention to when submitting ethics documents in the registration materials for IVDs?
A: When registering an in vitro diagnostic reagent, the clinical trial must comply with the ethical guidelines of the Helsinki Declaration and must be approved by the Ethics Committee of the Clinical Trial Institute. In this part of the application, the ethics committee’s review opinion and the subject’s informed consent form should be submitted.
The original written opinion from, and stamped by, Ethics Committee should be submitted, and the version number should be stated. The product information and clinical trial information should be consistent with the actual clinical situation. If a program modification occurs during the test, it should be approved by the ethics committee and submitted to the ethics committee for comments on the program revision. The institutions conducting clinical trials should submit the review opinions of the ethics committee. If there is no ethics committee in a special medical institution (such as a Center for Disease Control), the agency should provide relevant information and ethical opinions.
If the clinical trial is exempted from the informed consent after review and approval by the ethics committee, it should be clearly stated the written opinion from the ethics committee.
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