Drugdu.com expert's response:

I. Enterprise Qualifications and Basic Documents

Medical Device Registration Application Form

Must include detailed information such as product name, model, specifications, intended use, manufacturing process, and quality control methods, accompanied by product photographs.

Enterprise Qualification Certificates

Business license.

Medical Device Manufacturing License (if already obtained).

Identity certificates and educational/professional qualification certificates of the legal representative, enterprise person in charge, and quality manager.

Power of Attorney

Required if the registration is handled by someone other than the legal representative or enterprise person in charge, with an authorized signature and official seal.

II. Technical Documentation and Product Information

Product Technical Files

Design principles, structural features, and performance specifications: Detailed descriptions of technical parameters, functional characteristics, and testing methods.

Bill of materials: Includes specifications, models, quality standards, and supplier qualification documents for raw materials, components, and assemblies.

Manufacturing process flowchart: Must annotate key and special processes, accompanied by process descriptions.

Product Quality Standard Documents

Clearly define product quality standards, including factory inspection items, methods, and acceptance criteria.

Product Instructions and Label Specimens

Must comply with the Regulations on Medical Device Instructions and Labeling, covering general name, model, specifications, production date, expiration date, performance, structure, intended use, contraindications, and precautions.

III. Testing and Clinical Evaluation Documents

Product Inspection Reports

Self-inspection report: Issued by the enterprise, complying with the Regulations on Self-Inspection for Medical Device Registration.

Third-party testing report: Issued by a qualified medical device testing institution, covering all product technical requirements.

Clinical Evaluation Documents

Clinical trial report: Required if clinical trials are necessary, including the clinical trial contract, protocol, report, and ethics committee opinion.

Comparative data with predicate devices: If clinical evaluation is completed through comparison with a predicate medical device, submit a comparative analysis covering basic principles, technical performance, and intended use.

Exemption from clinical evaluation justification: For products listed in the Catalog of Medical Devices Exempt from Clinical Evaluation, submit reasons and evidence for exemption.

IV. Quality Management System Documents

Quality Manual

Describes the quality policy, objectives, and overall requirements of the quality management system.

Procedure Documents

Cover operational specifications for the entire supply chain, including procurement, production, inspection, and sales.

V. Work Instructions

Detailed operational guidelines, such as equipment operating procedures and inspection methods.

Quality Records

Include incoming inspection, in-process inspection, and finished product inspection records, as well as internal audit reports and management review reports.

VI. Quality Management System Verification Documents

Such as GMP certification certificates or quality management system assessment reports.

Risk Management and Safety Documents

Product Risk Analysis Report

Must analyze energy hazards, biological hazards, environmental hazards, usage hazards, and functional failure risks, with proposed risk control measures.

Safety and Effectiveness Research Documents

Such as product performance research reports and biocompatibility test reports.

Additional Documents

Product Authenticity Self-Declaration

Signed and sealed by the legal representative or enterprise charger, pledging the authenticity, legality, and validity of submitted materials.

Electronic Copies of Registration Documents

Include electronic versions of the registration application form, instructions, labels, etc.

Change Registration Explanation

Required for change registrations, including a description of changes and a comparison table.

VII. Special Product Requirements

Software-Based Medical Devices: Must submit software requirements specifications, software design documents, and software testing reports.

Sterile/Implantable Medical Devices: Must submit sterile/implantable performance research reports and sterilization process validation reports.