Yes, NMPA certification includes comprehensive regulatory compliance checks. These checks ensure that medical devices meet Chinese safety, efficacy, and quality standards. Key aspects of these compliance checks include:

1. Document Review: Detailed examination of submitted documents, including technical files, labeling, and clinical data.

2. Product Testing: Verification through testing to ensure the device meets NMPA’s safety and performance standards.

3. Clinical Trials: For certain devices, clinical trials may be required to demonstrate efficacy and safety in the Chinese population.

4. Manufacturing Facility Inspection: Assessment of the manufacturing site to ensure compliance with Good Manufacturing Practice (GMP) and other relevant standards.

5. Quality Management System (QMS) Compliance: Evaluation of the manufacturer’s quality management system to ensure it adheres to NMPA regulations.

These checks are designed to confirm that medical devices are safe, effective, and compliant with Chinese regulatory requirements before they can be marketed in China.

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