The scope of medical device registration in China, governed by the NMPA, encompasses various categories and aspects:

1. Device Classification: Medical devices are classified into three categories based on risk:

   • Class I: Low risk; registration is simpler, often requiring only a filing.
   • Class II: Moderate risk; requires more detailed documentation and testing.
   • Class III: High risk; necessitates extensive clinical data and rigorous evaluation.

2. Types of Devices: This includes a wide range of products, such as:

   • Diagnostic devices (e.g., imaging equipment, in vitro diagnostics)
   • Therapeutic devices (e.g., surgical instruments, implantable devices)
   • Monitoring devices (e.g., patient monitoring systems)
   • Consumables (e.g., syringes, gloves)

3. Regulatory Documentation: Manufacturers must prepare comprehensive documentation, including:

   • Quality management system certification (e.g., ISO 13485)
   • Clinical evaluation reports
   • Technical files detailing design and manufacturing processes

4. Post-Market Surveillance: Once registered, devices must comply with ongoing post-market surveillance requirements, including adverse event reporting and periodic reviews.

5. Import and Export Regulations: Foreign manufacturers must comply with additional regulations for importing devices into China, including obtaining an import license.

6. Labeling and Instructions for Use: Registration includes requirements for appropriate labeling, which must be in Chinese and provide clear usage instructions.

Overall, the scope of registration is comprehensive, aimed at ensuring the safety and effectiveness of medical devices in the Chinese market.

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