For NMPA (National Medical Products Administration) registration of medical devices in China, you’ll need to prepare and submit a comprehensive set of documents and materials. Here’s a detailed list of the typical requirements:
1. Application Form
- Application Form: Complete the NMPA application form specific to the type of device being registered.
2. Technical Documentation
- Product Description: Detailed description including the device's intended use, indications, contraindications, and mechanism of action.
- Product Specifications: Technical specifications such as dimensions, materials, and performance characteristics.
- Device Classification: Information on the classification of the device (Class I, II, or III).
3. Manufacturing Information
- Manufacturer’s Information: Name, address, and contact details of the manufacturer. Include a certificate of establishment or business license.
- Quality Management System (QMS): Proof of compliance with international standards (e.g., ISO 13485) or the equivalent Chinese standard.
4. Clinical Data
- Clinical Evaluation Report: Evidence from clinical trials or studies showing the safety and effectiveness of the device.
- Clinical Trial Reports: If applicable, results from clinical trials conducted on the device.
5. Safety and Performance Testing
- Testing Reports: Reports from accredited laboratories demonstrating compliance with safety and performance standards (e.g., electrical safety, biocompatibility).
6. Labeling and Instructions for Use (IFU)
- Labeling: Labels must include product name, intended use, instructions for use, warnings, and manufacturer information.
- Instructions for Use (IFU): Detailed instructions including how to use, handle, and dispose of the device, along with safety information. Ensure it is in Chinese.
7. Technical File
- Design Dossier: Includes design specifications, development process, and risk management documentation.
- Manufacturing Process Information: Details about the production process, including quality control measures.
8. Certificates and Proofs
- Certificates: Include any certificates from other regulatory bodies if the device is already registered elsewhere (e.g., CE, FDA).
- Proof of Import: If applicable, provide evidence of import license or relevant import documentation.
9. Financial Documentation
- Fee Payment: Proof of payment for the application and registration fees.
10. Additional Documentation
- Legal Representative: Documents confirming the appointment of a legal representative in China, if applicable.
- Power of Attorney: If a local agent or representative is handling the registration, a power of attorney document is required.
Useful Links
Ensure all documents are translated into Chinese and comply with NMPA formatting and submission requirements. Consulting with a local regulatory expert can help ensure all requirements are met accurately.
Contact Us：
Whatsapp or Wechat：+86 15816864648；email address：hito.lin@grzan.cn
.png)
.jpg "1(8).jpg")
