How to Register a Medical Device in China

This video provides a clear, practical overview of the medical device registration process in China, including how to classify your device, compile a compliant regulatory dossier, appoint a China Agent, and meet clinical testing requirements under the National Medical Products Administration (NMPA). Whether you’re preparing your first China submission or expanding from other markets, this guide will help you understand the core regulatory milestones and how to navigate them efficiently.

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China’s medical device market is one of the fastest-growing in the world. Valued at over USD $40.96 billion by 2025 and expected to grow at 7.98% CAGR through 2029, the market offers strong demand across diagnostics, digital health, and therapeutic devices. The IVD sector alone is projected to reach USD $23.81 billion by 2030, fueled by aging demographics, chronic disease management, and government-led healthcare innovation. But the size of the opportunity is matched by regulatory complexity.

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Before a device can be sold in China, manufacturers must register with the NMPA, which applies a risk-based classification system (Class I, II, III) that determines the scope of evidence required. Class II and III devices often require type testing in NMPA-accredited Chinese labs, local clinical trials, and strict documentation standards. In addition, country-of-origin approval is mandatory, and a local China Agent must be appointed to act as your in-market liaison for regulatory communications, labeling compliance, vigilance, and license maintenance.

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Topics covered in this video include:

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• China’s Medical Device Market Overview
  A snapshot of China’s growth trajectory and why it’s a high-priority market for global manufacturers.
• Regulatory Pathways and NMPA Role
  Introduction to how the NMPA oversees classification, submission, and post-market activities.
• How Are Devices Classified?
  Overview of Class I, II, and III categories and how classification impacts testing and documentation.
• China Agent
  Why appointing a local regulatory representative is essential and what they’re responsible for.
• Compilation of Regulatory Dossier for NMPA Submission
  China-specific technical file expectations and key components.
• Local Clinical Trials
  When local studies are required and how to prepare for them.
• Importance of Origin Country Approval
  Why NMPA expects your device to be approved in its home country before registration.
• Partnering with Pure Global Benefits
  Learn how Pure Global simplifies the China process with bilingual teams, in-country support, and global coordination.

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Need help registering with the NMPA?
Pure Global offers end-to-end regulatory support for manufacturers entering China. From classification and dossier preparation to clinical trial oversight and post-market compliance, our expert team handles every step of the China medical device registration process so you can focus on growing your business.

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