Drugdu.com expert's response:

I. Requirements for Completeness of Declaration Materials

Basic Certification Documents

Business License: Submit a copy of the enterprise’s valid business license (with expiration date).

Personnel Qualifications: Provide identity certificates and educational/professional title certificates for the legal representative, enterprise负责人 (enterprise leader), and quality manager to verify enterprise and personnel qualifications.

Contract Manufacturing: If outsourcing production, submit the contract manufacturer’s Medical Device Production License and the signed contract manufacturing agreement between both parties.

Core Product Documents

Medical Device Registration Application Form: Detailed description of product name, specifications, model, structure, intended use, production process, and quality control methods. Must be signed and stamped by the legal representative or responsible person.

Product Instructions and Label Specimens: Include generic name, model, specifications, manufacturer information, product technical requirement number, production date, expiration date, performance, structure, intended use, contraindications, and precautions.

Product Technical Requirements: Specify technical parameters, performance indicators, and testing methods in compliance with national/industry standards (e.g., GB 9706.1 for medical electrical safety).

Risk Analysis Documentation: Cover risk identification (e.g., electrical safety, biocompatibility) and control measures throughout the product lifecycle.

II. Requirements for Technical Document Rigor

Product Technical Requirements

Drafted in accordance with the Guidelines for Drafting Technical Requirements for Medical Devices to ensure verifiable performance indicators (e.g., blood pressure monitor accuracy, electromagnetic compatibility).

Testing methods must align with national/industry standards to avoid rejections due to non-compliance.

Supporting Research Materials

Biocompatibility Evaluation: Provide material descriptions, contact properties, biological testing justifications, and exemption arguments.

Software Documentation: For devices with embedded software, submit a software description document including basic information, implementation processes, core algorithms, and version naming rules.

Sterilization/Disinfection Process: Clarify sterilization methods, parameters, sterility assurance level (SAL), and residual toxicity mitigation measures.

III. Requirements for Clinical Evaluation Adequacy

Clinical Trial Pathway Selection

Exemption from Clinical Trials: If eligible (e.g., low-risk, validated by similar products), submit exemption justifications and supporting data.

Equivalence Comparison: Provide clinical trial reports or literature for similar products, comparing differences in working principles, structural components, performance indicators, and intended use.

Self-Conducted Clinical Trials: Submit clinical trial contracts, protocols, and reports, ensuring compliance with Good Clinical Practice (GCP) requirements (e.g., conducted in Grade II or higher hospitals).

Clinical Literature Support

Reference academic papers, monographs, or literature reviews published in provincial-level or higher core medical journals to substantiate expected clinical outcomes.

IV. Requirements for Quality Management System Compliance

Submission of System Documentation

Submit quality manuals, procedural documents, and work instructions to demonstrate a robust quality management system.

If ISO 13485-certified, provide the certification as supplementary proof.

Production Quality Control

Describe the production process (e.g., flowchart) and identify critical process control points.

For sterile products, specify initial packaging information compatible with sterilization methods.

V. Requirements for Regulatory Compliance

Accurate Classification

Cross-reference the Medical Device Classification Catalog and NMPA classification notices to confirm product category. Submit a classification request to provincial NMPA if functional, structural, or intended use ambiguities exist.

Policy Utilization

Green Channel Application: Eligible for innovative devices (e.g., breakthrough technology, significant clinical value) or priority-reviewed devices (e.g., urgently needed for public health emergencies). Approval timelines may be reduced by 30–50%.

Renewal Registration: Submit renewal applications 6 months prior to certificate expiration to avoid lapse. Apply for registration changes promptly if technical requirements or intended use are modified.

Post-Market Surveillance

Comply with adverse event reporting (via the National Medical Device Adverse Event Monitoring System) and annual report submissions to ensure lifecycle compliance.