For NMPA (National Medical Products Administration) registration of medical devices in China, a comprehensive set of documents and materials is required. Here’s a detailed breakdown of what you need to prepare:

1. Application Form

• Completed Application Form: The form must be filled out accurately and signed by the authorized representative of the manufacturer or the manufacturer itself.

2. Company Documentation

• Business License: A copy of the business license or equivalent registration certificate of the manufacturing company. This document should be in the local language and include relevant information about the company.
• Quality Management System (QMS) Certification: Proof of ISO 13485 or equivalent certification. For certain devices, GMP (Good Manufacturing Practice) certification may also be required.

3. Device Information

• Device Description: Detailed description of the medical device, including its intended use, components, and operational principles.
• Product Specifications: Technical specifications, including performance characteristics and compliance with relevant standards.
• Device Labeling: Samples of the product labeling, packaging, and Instructions for Use (IFU). These should comply with Chinese regulations, including language requirements.

4. Technical Documentation

• Technical File: Comprehensive documentation including design and manufacturing details, risk analysis, and performance data.
• Risk Management Report: Documentation of potential risks associated with the device and measures taken to mitigate those risks.
• Pre-clinical Testing Reports: Data from pre-clinical tests, such as biocompatibility and performance testing, demonstrating the device's safety and effectiveness.

5. Clinical Data

• Clinical Evaluation Report: Data from clinical trials or evaluations demonstrating the device’s safety and effectiveness. This is essential for Class II and III devices.
• Clinical Trial Reports: Detailed reports from clinical trials conducted in China or internationally. For some devices, clinical trials in China may be mandatory.

6. Manufacturing Information

• Manufacturing Process: Detailed description of the manufacturing process, including quality control measures.
• Site Inspection Reports: For Class III devices, NMPA may require an on-site inspection of the manufacturing facility.

7. Translation Requirements

• Certified Translations: All documents must be translated into Chinese by a certified translator. This includes the application form, clinical data, labeling, and other relevant documentation.

8. Additional Documents

• Power of Attorney: If the application is submitted by an agent or representative, a power of attorney document authorizing them to act on behalf of the manufacturer.
• Legal Representative’s Identification: A copy of the legal representative’s identification document, such as a passport or national ID.

9. Submission Process

• Submission Package: Organize all the documents into a submission package as per NMPA guidelines.
• Online Submission: Submit the package through the NMPA’s online submission system or as directed by NMPA.
• Fees: Pay the required fees associated with the registration process. Ensure you keep proof of payment.

10. Post-Submission

• Response to Queries: Be prepared to provide additional information or clarification if requested by NMPA during the review process.
• Review and Approval: The review process duration can vary. Follow up as needed and stay informed about any updates or additional requirements.

Tips for Preparation

• Consult Regulatory Experts: Engage with local regulatory consultants who are experienced with NMPA registration to ensure compliance and streamline the process.
• Stay Updated: Regulations and requirements may change, so regularly check for updates from NMPA.

Having all these documents and materials well-prepared and organized will facilitate a smoother registration process with NMPA and help ensure compliance with Chinese regulatory standards.

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