When applying for NMPA certification in China, you must submit a comprehensive set of documents to demonstrate that your medical device meets the regulatory requirements. Here’s an outline of the typical submission requirements:

1. Application Form

Completed Form: Fill out the NMPA application form with basic information about the device, manufacturer, and applicant.

2. Product Information

Product Description: Detailed description of the medical device, including its intended use, technical specifications, and features.

Design and Functionality: Information on the device's design, functionality, and how it operates.

3. Technical Documentation

Technical Dossier: A detailed dossier that includes:

• Device Specifications: Technical details, including design, materials, and manufacturing processes.
• Testing Reports: Results from required testing, including safety, performance, and biocompatibility tests.
• Clinical Data: Clinical trial results or clinical evaluation reports demonstrating the device’s safety and effectiveness. Clinical trials conducted in China may be required for certain devices.
• Risk Management: Risk analysis and management strategies.

Compliance Statements: Proof of compliance with relevant Chinese and international standards (e.g., GB standards, ISO standards).

4. Manufacturing Information

Manufacturing Facility Details: Information about the manufacturing site, including facility inspections and quality management systems.

Quality Management System (QMS): Documentation showing compliance with QMS standards, such as ISO 13485.

5. Labeling and Packaging

Labeling: Labels must be in Chinese and include all necessary information as per NMPA requirements, such as product name, usage instructions, and warnings.

Packaging: Packaging must meet local standards and include all required labeling information.

6. Legal Documents

Business Licenses: Copies of business licenses for the manufacturer and importer.

Authorized Agent Agreement: Documentation appointing a local authorized agent in China responsible for handling regulatory matters.

7. Clinical Evaluation

Clinical Evaluation Report: For some devices, especially high-risk ones, a clinical evaluation report or evidence of clinical trials may be required.

8. Fee Payment

Fee Documentation: Proof of payment for registration and review fees. The exact amount can vary based on the device type and complexity.

9. Additional Requirements

Translation: All documents must be translated into Chinese. Ensure translations are accurate and complete.

Other Supporting Documents: Depending on the device and specific requirements, additional documents may be needed, such as manufacturing process details, post-market surveillance plans, or additional test reports.

Submission Process

Online Submission: Many documents can be submitted through the NMPA’s online registration system.

Physical Submission: Some documents may need to be submitted physically, depending on the specific requirements and device type.

Summary

The submission requirements for NMPA certification include a detailed application form, comprehensive technical documentation, manufacturing information, labeling and packaging details, legal documents, and proof of fee payment. Ensure all documents are prepared in Chinese and meet NMPA’s specific requirements to facilitate a smooth certification process.