July 13, 2018
In order to enhance the requirements for clinical trial approval for non-active implantable medical devices, CNDA has issued “the Guidelines for the Submission Documents of Clinical Trial Application for Non-active Implantable Medical Devices” (hereinafter referred to as the Guideline) in June.
This guideline further elaborates the required information to be placed under the test product description, preclinical research data, and clinical trial protocol for Class III non-active implantable medical devices. These will not influence the technical review and the administrative approval of the CNDA. In addition, this guideline doesn’t limit the preparation work for the clinical trial approval application documents for such products.
Reference: Official press