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Create NMPA Project

Available Plans

Pro / Max / CRO

Steps

  1. Select regulatory framework: "NMPA"
  2. Fill in device information:
    • Project name
    • Chinese device name
    • English device name
    • NMPA classification number
    • Registration type (imported / domestic)
    • Manufacturer
  3. Click "Create"

Available Tasks

  • NMPA Registration: Full registration material generation
  • Clinical Evaluation (NMPA): NMPA-required clinical evaluation
  • CE Exempt: Clinical evaluation exemption documentation

Context Files

Recommended uploads:

  • Product technical specifications
  • Design and manufacturing information
  • Test reports
  • Foreign market approval (for imported devices)

Registration Chapters