Preparing application files for NMPA (National Medical Products Administration) registration of medical devices in China involves compiling a comprehensive set of documents that demonstrate the safety, efficacy, and quality of your device. Here are the key documents required and how to prepare them:

Required Documents for NMPA Registration:

1. Device Description and Technical Specifications:

   • Detailed description of the medical device, including its intended use, principle of operation, and specifications (e.g., dimensions, materials used).
   • Technical specifications outlining performance characteristics, design rationale, and any unique features.

2. Quality Management System (QMS) Documentation:

   • ISO 13485 Certification: Evidence of compliance with ISO 13485 or equivalent quality management system standards. This certification demonstrates that your manufacturing processes meet international quality standards.
   • Documentation of your QMS implementation, including procedures for design control, risk management, production, and process controls.

3. Clinical Data and Evaluation:

   • Clinical Evaluation Report: For Class II and III devices, provide a clinical evaluation report (CER) that summarizes and evaluates clinical data related to the device's safety and efficacy.
   • Clinical trial data (if applicable): Conducted in accordance with NMPA requirements. Include study protocols, results, and conclusions.

4. Testing Reports:

   • Performance Testing: Results of testing that demonstrate the device meets specified performance criteria.
   • Biocompatibility Testing: Reports indicating the device's compatibility with biological systems, as per ISO 10993 standards.
   • Electrical Safety Testing: Compliance with applicable electrical safety standards (e.g., IEC 60601 series).

5. Risk Management Documentation:

   • Risk Management Plan: Identify potential hazards associated with the device and describe measures taken to mitigate these risks throughout the device lifecycle.

6. Labeling and Instructions for Use (IFU):

   • Labeling: Ensure labeling complies with NMPA requirements, including device identification, usage instructions, warnings, and precautions. Labels must be in Chinese.
   • IFU: Instructions for Use translated into Chinese, providing clear guidance on device operation, storage, and maintenance.

7. Manufacturing Information:

   • Details about manufacturing processes, facilities, and controls. Provide evidence of compliance with Good Manufacturing Practice (GMP) regulations or equivalent standards.

8. Authorization Letter:

   • If you are using a local agent or representative in China, include an authorization letter empowering them to act on your behalf for NMPA registration purposes.

How to Prepare Application Files:

1. Gather Documentation Early: Start compiling necessary documentation well in advance of submission to ensure completeness and accuracy.

2. Translate Documents: Translate all documentation into Chinese. Use professional translation services to ensure accuracy and compliance with regulatory requirements.

3. Organize Files: Organize application files according to the NMPA's requirements and guidelines. Label each document clearly and ensure they are in a logical order for review.

4. Compile Technical Dossiers: Create a comprehensive technical dossier that includes all required documents, organized into sections (e.g., device description, QMS, clinical data, testing reports).

5. Review for Compliance: Review each document to ensure it meets NMPA regulatory standards and addresses all applicable requirements.

6. Submit Application: Submit your application and supporting documents through the NMPA's designated submission channels, which may include online platforms or authorized third-party service providers.

7. Prepare for Review and Inspection: Anticipate a thorough technical review and potential on-site inspection of manufacturing facilities by NMPA inspectors. Ensure readiness to respond to any inquiries or requests for additional information.

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