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Interpretation to CFDA’s Quality Management of Medical Device Clinical Trials

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A. About the one-year validity period of the registration test report of medical device clinical trials

Article 7 of the “Medical device clinical trial quality management practices” provides: “quality inspection results should include self-inspection report and product registration and inspection report issued by a qualified inspection agency within one year.” The one year validity period of the product registration and inspection report which is issued by the qualified inspection agency in case that the clinical trials are carried on in multi-center will be calculated from the issue time of inspection report to ethical review and approval time of leading unit of clinical trials. The report which is issued by the qualified inspection agency in case that the clinical trials are carried on in non-multi-center will be calculated from the issue time of inspection report to respective ethic review and approval time of each unit of clinical trials.

B. About the filing of medical device clinical trials

In accordance with the requirements of Article 1 of the “Notice on the Relevant Matters of Medical Devices Clinical Trial” (No. 87 issued in 2015), the medical device clinical trial can apply filing to the local provincial food and drug supervision and management department where applicant/agency are staying after the applicants enter into agreements or contracts with each clinical trial institution. Clinical trials are carried out after filing. The applicants will provide all forms received before the same clinical trial. The provincial food and drug supervision should indicate the case in the “filing number” column of the form. This way the clinical trial filing number of the same project is unified and checkable.

 


About China Med Device, LLC (CMD) CMD provides turn-key solution for Western medtech companies with regulatory and commercialization services. CMD helps its clients accelerate China entry and growth by offering: market Intelligence and research; CFDA regulatory services (premarket submission, clinical evaluation, clinical trial design & management, post market compliance and legal representation), and other commercial services. If you have an inquiry or feedback regarding our services please email us at info@ChinaMedDevice.com.

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