Understanding the essential requirements for registering NMPA in China
分类:公司新闻 发布时间:2024-08-29 17:14:48
These requirements ensure that devices meet NMPA’s safety, efficacy, and quality standards for the Chinese market.

To register a medical device with the NMPA in China, essential requirements include:

  1. Product Classification: Determine the device’s class (I, II, or III) based on risk. Class I devices have the simplest requirements, while Class II and III are more stringent.

  2. Technical Documentation: Prepare comprehensive documentation, including device description, intended use, manufacturing processes, and safety and performance data.

  3. Clinical Trials: For Class II and III devices, provide clinical trial data demonstrating safety and efficacy. Trials may need to be conducted in China or include data from international trials.

  4. Quality Management System (QMS): Demonstrate compliance with ISO 13485 or equivalent standards. QMS certification is required for all classes.

  5. Local Representative: If the manufacturer is not based in China, appoint a local agent or representative responsible for regulatory affairs.

  6. Registration Application: Submit the application form, technical documents, clinical data, and other required materials to NMPA for review.

  7. Fees: Pay applicable registration fees as part of the application process.

These requirements ensure that devices meet NMPA’s safety, efficacy, and quality standards for the Chinese market.

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