Yes, medical devices need to have product certificates, along with other essential documentation, as part of the NMPA (National Medical Products Administration) certification process in China. These product certificates serve as critical evidence that the medical device complies with the necessary technical, safety, and performance standards required by Chinese regulations. Here’s how product certificates fit into the NMPA certification process:

1. Product Certificates: Definition and Importance

A product certificate typically verifies that a medical device meets the required quality and safety standards. This certificate can be in the form of test reports, compliance certificates from accredited testing laboratories, or certificates of conformity issued by recognized bodies.

For the NMPA certification, the product certificates confirm that the device adheres to international and national standards like:

• ISO 13485 (Quality Management System for medical devices)
• ISO 14971 (Risk Management for medical devices)
• IEC 60601 (Electrical safety for medical electrical equipment)
• GB Standards (Chinese national standards relevant to medical devices)

2. Types of Product Certificates Required

Different product certificates may be required depending on the type and classification of the medical device:

• Conformity Assessment Reports: These reports certify that the medical device meets the necessary technical specifications and performance requirements.
• Testing Certificates: Test results from accredited laboratories that demonstrate compliance with electrical, mechanical, biological, or other relevant standards. This includes safety, electromagnetic compatibility (EMC), and biocompatibility testing, depending on the device type.
• Clinical Evaluation Reports: Higher-risk devices (Class II and III) may require clinical data to support their safety and effectiveness, which can be documented in a clinical evaluation report. This report assesses the clinical performance based on existing literature or clinical trials.
• Sterility Certificates: For sterile medical devices, a certificate proving the sterilization method and process validation may be needed.

3. Key Documents and Certificates in NMPA Certification

The following certificates and documents are usually required as part of the submission package for NMPA certification:

• Product Technical Specifications: Detailed description of the product’s design, components, and intended use.
• Test Reports: These may include functional testing, safety testing, electromagnetic compatibility (EMC), and biocompatibility testing.
• Risk Management Report: Based on ISO 14971, it should describe the risk control measures in place for the device.
• Clinical Evaluation: For higher-risk devices, clinical data or a clinical evaluation report is necessary.
• Quality Management System (QMS) Certification: Evidence of the manufacturer’s compliance with ISO 13485 or a similar quality management system standard.
• Product Labeling and Instructions for Use: Must comply with Chinese regulations and include necessary translations.
• Declaration of Conformity: This document is a formal statement from the manufacturer that the device meets all applicable regulatory requirements.

4. Role of Testing Laboratories

Product testing is a crucial part of the certification process. The testing should be performed by laboratories accredited by the NMPA or other recognized bodies. In some cases, the product must be tested in China by accredited local labs to meet the country-specific GB standards.

5. How Product Certificates Support NMPA Certification

The product certificates are part of the comprehensive technical dossier that is submitted to the NMPA. These certificates:

• Prove Compliance: They demonstrate that the medical device complies with the technical standards and regulatory requirements in China.
• Support Safety and Performance: They validate the safety and efficacy of the device, which is particularly important for higher-risk devices.
• Facilitate the Registration Process: Well-documented product certificates can speed up the registration and approval process by reducing the chances of queries or requests for additional information from the NMPA.

6. Class I, II, and III Devices

The depth and type of product certificates required vary depending on the risk classification of the device:

• Class I: These are low-risk devices, and self-declaration or basic testing reports might suffice. Clinical evaluations are generally not required.
• Class II: These medium-risk devices require more comprehensive testing reports and, in some cases, clinical evaluation data.
• Class III: High-risk devices require a full set of testing certificates, including performance and safety testing, as well as clinical evaluation reports.

7. Post-Certification Surveillance

After the device is certified and marketed in China, the manufacturer must engage in post-market surveillance, which may involve periodic audits, additional testing, and reporting of adverse events to maintain the certification.

Conclusion

Product certificates are a crucial element of the NMPA certification process in China. They help prove that medical devices meet the required safety, quality, and performance standards and are necessary for both the application and approval stages. Without these certificates, it is unlikely that a medical device would receive NMPA certification, particularly for higher-risk Class II and III devices.

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