F&D Group assists medical device manufacturers in completing China National Medical Products Administration (NMPA) registration, ensuring compliance with regulatory requirements and facilitating market entry.

1. Testing Services

(1) Product Safety and Performance Testing

·    Biocompatibility Testing (GB/T 16886 / ISO 10993): Cytotoxicity, skin irritation, sensitization, etc.

·       Electrical Safety & Electromagnetic Compatibility (GB 9706 / IEC 60601)

·       Mechanical Performance Testing for Passive Medical Devices (e.g., tensile strength and fatigue testing for implants)

·       Sterilization Validation (GB 18279 & GB 18280)

·       In Vitro Diagnostic (IVD) Performance Testing (GB/T 29791) (accuracy, stability, cross-reactivity, etc.)

·       Packaging Integrity Testing (GB/T 19633) (Sterile packaging requirements for medical devices)

(2) Chemical, Physical, and Microbiological Testing

·       Chemical composition analysis, degradation product analysis

·       Bacterial endotoxin testing, microbial limit testing

·       Pyrogen testing, sterility testing

(3) Software & Cybersecurity Testing

·       Medical Device Software Validation (YY/T 0664 / IEC 62304)

·       Cybersecurity Testing (YY/T 0316 / ISO 14971)

2. Consulting Services

(1) Registration Strategy & Compliance Consulting

·       Medical Device Classification Guidance (Based on “Medical Device Classification Catalogue”)

·       NMPA Registration Pathway Selection (Domestic/Imported, Class I, II, III devices)

·       Guidance on Preparing and Submitting Registration Documents

(2) Technical Documentation Preparation & Review

·       Product Technical Requirements (PTR) Preparation

·       Research Documentation Support (Risk Management Report, Clinical Evaluation Report, Performance Studies, etc.)

·       Instructions for Use (IFU) & Labeling Review

(3) Quality Management System (QMS) Consulting

·       Guidance on Compliance with Medical Device Good Manufacturing Practice (GMP)

·       Manufacturer Licensing & Filing Support

(4) Clinical Evaluation & Trial Support

·       Clinical Evaluation Report (CER) Preparation

·       Clinical Trial Design & Data Analysis

·       Ethics Committee Approval Support

(5) Post-Market Surveillance (PMS) & Compliance Support

·       Adverse Event Monitoring & Reporting (MAE)

·       Guidance on Change Filings & Registration Amendments

3. Training Services

(1) NMPA Regulatory Training

·       Interpretation of “Medical Device Supervision & Administration Regulations” and NMPA registration process

·       Medical Device Classification Catalogue and classification determination

·       Registration requirements for imported medical devices

(2) Technical Documentation Training

·       Product Technical Requirements (PTR) Writing & Case Studies

·       Clinical Evaluation Report (CER) Writing Guidelines

(3) Quality Management System Training: NMPA GMP Requirements & Compliance Assessment

(4) Post-Market Compliance Training

·       Adverse Event Monitoring & PMS System Development

·       Change Filing & Registration Amendment Process Overview