Drugdu.com expert's response:

I. Regulatory Framework and Product Classification

1. Clarify Regulatory Requirements

Domestic Registration: Comply with China’s Medical Device Supervision and Administration Regulations, Medical Device Registration and Filing Measures, etc.

Export Compliance: Meet target country/region standards (e.g., EU CE, U.S. FDA).

Key Point: Regulations are frequently updated; track changes via the NMPA website or professional agencies.

2. Accurate Product Classification

Classify risk levels per China’s Medical Device Classification Catalog:

Class I (low risk), Class II (moderate risk), Class III (high risk).

Registration processes vary significantly by class.

Recommendation: Use the NMPA’s "Medical Device Classification Determination" system for uncertain cases. For innovative products, prepare for the "Special Approval Pathway for Innovative Medical Devices."

II. Technical Documentation and Testing

1. Prepare Complete Technical Files

Product Technical Requirements (CTD):

Detail performance metrics (e.g., filtration efficiency for surgical masks), testing methods, and structural composition.

Ensure quantifiable, verifiable metrics aligned with national standards (e.g., GB, YY series).

Risk Analysis Report:

Follow YY/T 0316 to analyze lifecycle risks (design, production, use) and mitigation measures (e.g., electromagnetic radiation, biocompatibility).

Design and Development Documentation:

Include records of design planning, inputs, outputs, validation, and confirmation to demonstrate compliance.

2. Conduct Full-Scope Testing

Testing reports must be issued by NMPA-recognized institutions (e.g., National Institutes for Food and Drug Control) and cover mandatory standards (biocompatibility, electrical safety).

Common Issues: Unqualified testing agencies, incorrect standard references, incomplete testing items.

Solution: Select CMA/CNAS-certified labs and confirm testing against current standards.

III. Clinical Evaluation and Trials

1. Determine Clinical Trial Requirements

Exemptions: Products listed in the Exempted Clinical Evaluation Catalog (e.g., certain Class I/II low-risk devices) may use comparative analysis instead of trials.

Mandatory Trials: Class III and high-risk Class II devices require trials at certified institutions, adhering to GCP guidelines with complete clinical reports.

Critical Requirement: Trial protocols must be ethics committee-approved, with traceable, authentic data.

2. Optimize Trial Design

Engage experienced Contract Research Organizations (CROs) to ensure statistically sound protocols and avoid rejections due to design flaws.

IV. Quality Management System and Production

1. Establish Compliant QMS

Build a file system per the Good Manufacturing Practice (GMP) for Medical Devices, covering production records, quality control, and nonconforming product handling to ensure traceability.

Audit Focus: Align actual production conditions with申报 (registration) materials, ensure staff familiarity with QMS documents, and maintain authentic records.

2. Apply for Production License Synchronously

Class II/III devices require concurrent application for a Medical Device Production License. Registration and production sites must match; for contract manufacturing, submit agreements and supplier qualifications.

V. Registration Submission and Review

1. Prepare Complete Submission Materials

Cross-check against the official Medical Device Registration Submission Requirements checklist for authenticity, completeness, and compliance.

Common Issues: Missing key documents (e.g., test reports, instructions), unsigned/unstamped files, disorganized materials.

Optimization: Use the electronic submission system (eRPS) to minimize errors.

2. Address Technical Review Feedback

Proactively submit clarifications for anticipated issues. For deficiency letters, coordinate cross-departmental responses (R&D, quality, clinical) within deadlines.

VI. Post-Market Surveillance

1. Establish Adverse Event Monitoring

Assign dedicated personnel to collect, analyze, and report adverse events, and develop a Post-Market Risk Management Plan (PMPF).

2. Manage Changes and Renewals

Notify NMPA of design/process/scope changes via Medical Device Registration Change Applications. Renew registration 6 months before expiration (5-year validity).

VII. Start-Up-Specific Recommendations

1. Strengthen Regulatory Process Management

Avoid prioritizing outcomes over processes; maintain standardized records across R&D, production, and sales to substantiate safety/efficacy claims.

2. Allocate Specialized Staff

Hire full-time R&D, quality, and technical personnel; avoid兼职 (part-time roles) in production/testing to ensure alignment with processes.

3. Leverage Professional Resources

Consult CROs or regulators to preempt delays from unfamiliarity. Participate in NMPA training programs to master registration frameworks systematically.