The scope of application for NMPA certification in China covers a range of medical devices, including both Class I (low-risk) and Classes II and III (higher-risk) devices. Compliance requirements include:
Registration Dossier: Submission of detailed technical documents, including product specifications, manufacturing processes, clinical data, and quality management system certifications.
Testing and Evaluation: Devices must undergo testing by accredited labs and meet specific safety and performance standards.
Manufacturing Quality Management System: Compliance with ISO 13485 or equivalent is required.
Local Representation: A local agent or representative in China is needed for the application process.
Clinical Trials: For higher-risk devices, clinical trials in China may be necessary.
Do you need detailed guidance on any specific aspect?
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Whatsapp or Wechat：+86 15816864648；email address：hito.lin@grzan.cn
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