China National Medical Products Administration (NMPA) has released draft regulations outlining how it will inspect medical device clinical trial institutions in China. The measures aim to ensure compliance with Good Clinical Practice (GCP) standards for medical devices and in vitro diagnostics (IVDs). Feedback on the regulations is open until April 10, 2024.
Key Highlights:
Types of Inspections: Inspections may be routine, cause-driven, or other types to ensure compliance and quality standards.
Priority Circumstances: Certain situations, such as authenticity issues, non-compliance conclusions, or excessive workload for principal investigators, may trigger increased inspection frequency.
Inspection Process: On-site inspections are primary, with remote inspections used when necessary.
Inspection Conclusions: Inspections result in conclusions of "Compliant," "Requires Rectification for Assessment," or "Non-Compliant" based on the severity of defects found.
Rectification: Organizations must promptly rectify identified defects and submit reports detailing causes, risk assessments, rectification measures, and effectiveness assessments.
Follow-up Actions: Depending on assessment results, institutions may need to self-correct defects or face suspension of new trials. Serious cases may lead to registration cancellation.
Filing Revocation: If filing is revoked, the institution cannot conduct new trials, and ongoing trials may not enroll new subjects.
If you have any feedback or questions regarding this guideline, please email me before April 10, 2024.
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Grace Fu
China Med Device, LLC
gpalma@ChinaMedDevice.comPhone US: (978) 390-4453
Phone China: 18201749732
www.ChinaMedDevice.com------------------------------