NMPA China Medical Device Registration

China, with its rapidly aging population, stands as one of the leading medical device markets globally. The country's long-term health governance plans aim to expand healthcare services and financial coverage, predicting a significant rise in healthcare expenditure in the years ahead. This growth presents substantial opportunities for medical device companies looking to enter or expand in the Chinese market.

China
Device Classification and Regulatory Pathways

Understanding Device Classifications and Regulatory Requirements in China

Regulatory Authority

Pure Global can assist with China medical device registration, ensuring NMPRA approval to sell in the Chinese market.

Classification

Medical devices in China are classified into Class I, II, and III, reflecting an ascending order of risk. Class I devices enjoy a more streamlined registration process, while Class II and III devices may require local clinical trials and in-country testing, depending on specific conditions such as having exact predicates or being listed on NMPA's clinical trial exemption list.

Key Requirements

Entering the Chinese market necessitates:

  • Classification of your products to ascertain the regulatory pathway and understand local clinical study and testing requirements.
  • Compilation of a comprehensive regulatory dossier for NMPA submission.
  • For Class II and III devices, conducting local clinical trials unless exemptions apply.
  • Products must have country of origin's approval to be eligible to enter China.
How We Can Help

Tailored Support for Market Entry

Leverage our expertise for a smooth market entry into China:

  • Guidance on classifying your products and outlining the regulatory pathway.

  • Assistance with compiling the regulatory dossier and navigating local testing and clinical study requirements when applicable.

  • Acting as your China Agent for NMPA registration, ensuring compliance with post-market requirements.

Frequently
Asked Questions

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We Provide Access To 28+ Markets Worldwide

Our team of experts and local representatives, supported by partnerships with hundreds of clinical labs and the extensive GRIP database for over 100 countries, accelerates product launches and ensures compliance across 28 countries.

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