China NMPA Requirements for Medical Devices

China represents a significant opportunity for medical device manufacturers, with imports soaring to $24 billion in the first half of 2021. To tap into this burgeoning market, compliance with the National Medical Products Administration (NMPA) regulations is key.

Navigating NMPA Approval with Intertek Expertise

To import medical devices into China, obtaining NMPA approval is crucial. Intertek's team of China market experts provides unparalleled support in meeting NMPA registration testing requirements, streamlining the approval process for manufacturers.

Understanding NMPA Self-Testing Regulations

In 2021, the NMPA introduced regulations allowing applicants to submit self-testing reports for medical device registration, marking a significant shift in the registration process. These reports can originate from either the manufacturer's internal lab or an accredited third-party lab, emphasizing the manufacturer's responsibility for the report's accuracy and adherence to quality management standards.

Quality Management System Requirements for Self-Testing

• Technical capability of personnel for testing
• Equipment suitability for testing requirements
• Adequate environmental facilities for testing
• Proper sample and testing quality control management
• Controlled test recording processes

Options for Conducting Self-Testing

Manufacturers have the flexibility to conduct self-tests internally, utilize a division within their group company with CNAS accreditation, or engage an accredited third-party lab. Regardless of the choice, the manufacturer bears primary responsibility for the test report's content and accuracy.

The Advantage of CMA Accredited Third-Party Labs

Collaborating with a China Inspection Body and Laboratory Mandatory Approval (CMA) accredited third-party lab offers numerous benefits, including a wide testing standard scope, experienced engineering teams, and reports tailored to meet NMPA's stringent requirements.

Intertek Solutions: Pioneering in CMA Accreditation

Intertek is at the forefront of meeting new testing requirements, with our Shanghai and Guangzhou labs working towards CMA accreditation. Our expertise and strong relationships within the industry, such as with CAMDI, position us as a one-stop solution for NMPA registration self-testing, ensuring a smoother and quicker testing process for manufacturers.

With over 50 years of experience, Intertek's global presence and comprehensive suite of solutions empower medical device manufacturers to navigate the complexities of global markets, including China. Our dedication to quality, safety, and sustainability ensures that our partners can confidently bring their innovations to market.