For NMPA Class II medical devices, the approval requirements include:
- Complete Application: Submission of a fully completed application form with all required documents.
- Device Information: Detailed description, technical specifications, intended use, labeling, and packaging.
- Manufacturer’s Documentation: Manufacturer’s business license, QMS certification, and production license.
- Clinical Data: Clinical evaluation reports or data demonstrating device safety and effectiveness.
- Testing Reports: Compliance with Chinese standards, with reports from accredited labs.
- Factory Inspection: Possible inspection of the manufacturing facility by NMPA.
- Local Representation: For foreign manufacturers, a local representative in China is required.
Approval depends on meeting these criteria and passing the NMPA's review process.
Contact Us：
Whatsapp or Wechat：+86 15816864648；email address：hito.lin@grzan.cn
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