Yes, medical devices must undergo a compliance review as part of the registration process in China. The compliance review ensures that the devices meet the regulatory requirements set forth by the National Medical Products Administration (NMPA), which is responsible for overseeing medical device registrations in the country.

Here are key aspects of the compliance review process:

1. Technical Review: This involves a thorough assessment of the device's technical specifications, design, and intended use. The NMPA evaluates whether the device complies with relevant Chinese standards (GB standards) or internationally recognized standards (such as IEC standards).

2. Quality Management System (QMS) Review: Manufacturers are required to demonstrate that their quality management system meets the standards specified by the NMPA, typically ISO 13485. This review ensures that the device is manufactured under controlled conditions that ensure consistent quality and safety.

3. Clinical Evaluation: For certain classes of medical devices, a clinical evaluation is required to assess the safety and performance based on clinical data. This evaluation helps confirm that the device is safe and effective for its intended use.

4. Testing and Verification: Medical devices may need to undergo testing to verify compliance with specific requirements, such as safety, performance, and electromagnetic compatibility (EMC). Testing reports from accredited laboratories are typically required as part of the compliance documentation.

5. Labeling and Instructions for Use (IFU): The compliance review includes an evaluation of the device labeling and IFU to ensure they meet Chinese regulatory requirements. This includes requirements for language (Chinese), content, and clarity to ensure proper use and safety.

6. Manufacturing Site Inspection: For higher-risk devices (Class II and Class III), the NMPA may conduct inspections of manufacturing facilities to verify compliance with manufacturing standards and processes.

Overall, the compliance review process is critical to ensure that medical devices meet the regulatory standards for safety, efficacy, and quality before they can be marketed and distributed in China. Working with experienced regulatory consultants or local representatives familiar with NMPA requirements can facilitate a smoother and more efficient registration process.

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