Drugdu.com expert's response:

The registration of Class II medical devices in China requires submission of key documents covering risk analysis, technical specifications, testing reports, clinical evaluation, labeling, quality management systems, and authenticity declarations. Detailed requirements are outlined below:

I. Foundational Qualification Documents

Medical Device Registration Application Form: Must include core details such as product name, model/specification, structural composition, and intended use, signed and stamped by the legal representative or responsible person.

Enterprise Qualification Proof: Copy of the business license (valid within its term). Medical Device Manufacturing License (if applicable; the registered product must fall within the approved scope).

Personnel Qualification Proof: Identity, educational, or professional title certificates for the legal representative, enterprise leader, and quality manager (the latter must have a medical device-related background).

II. Product Technical Documentation

Product Technical Report: Covers design principles, structural composition, manufacturing materials, performance indicators, and production processes. Must provide the product technical requirement number and explain the basis for key technical performance indicators.

Safety Risk Analysis Report: Comprehensive analysis of risks such as energy hazards, biological hazards, and environmental hazards, with proposed risk control and mitigation measures.

Product Standards and Explanation: Adoption of national or industry standards, or registered product standards, with standard text and compliance declaration provided.

III. Testing and Clinical Evaluation Documentation

Product Testing Report: Issued by a qualified medical device testing institution, covering key indicators specified in the product technical requirements. Pre-evaluation opinion must confirm compliance and conclusions of the testing report.

Clinical Evaluation Documentation: Exemption from Clinical Trials: For products listed in the Catalogue of Medical Devices Exempt from Clinical Evaluation, submit comparative data with catalogue entries and equivalence proof.

Predicate Device Comparison: For products comparable to legally marketed devices, provide detailed comparative analysis reports on performance parameters and clinical data, supported by non-clinical data (e.g., lab studies, animal testing) or clinical literature.

Clinical Trials: For high-risk or innovative products, submit complete clinical trial documentation, including contracts, protocols, reports, and ethics committee approvals.

IV. Instructions for Use and Labeling

Product Instructions for Use: Must specify the generic name, model/specification, manufacturer details, product technical requirement number, production date, expiration date, performance structure, intended use, contraindications, and precautions.

Label Specimen: Includes basic information such as product name, model/specification, production date, and expiration date, consistent with registration certificate content.

V. Quality Management System Documentation

Quality Manual and Procedures: Covers product design control, development, research processes, and production quality control measures.

Production Quality System Certification: Provide ISO 13485 certification or other valid quality management system assessment documents.

Production Facility and Equipment Proof: Property or lease certificates for production and operational premises, along with a list of production facilities and equipment.

VI. Other Key Documentation

Authenticity Self-Declaration: Signed and stamped by the legal representative or responsible person, committing to the truthfulness of submitted materials and legal liability.

Authorization Letter: If applicable, provide authorization proof and identity documents for the handling agent.

Special Requirement Proof: Additional materials may be required based on product characteristics, such as import agent agreements, contract manufacturing agreements, or product samples.

VII. Key Considerations

Regulatory Updates: Stay informed of the latest regulations and guidance documents issued by the National Medical Products Administration (NMPA) to ensure compliance.

Material Completeness: All documents must be complete, legible, printed on A4 paper, bound with a table of contents, and submitted with stamped copies and electronic versions.

Pre-Submission Communication: Engage with the review center early to understand province-specific evaluation criteria and avoid delays due to insufficient documentation.