FILTER

• Pre-Market
  1. Product Classification
  2. Labeling & UDI
  3. Product R&D
  4. Innovative Medical Devices
  5. Naming Rules
  6. Developing Experiments
  7. Registration Units
  8. IFU & Labeling
• Product Type Testing
  1. Product Techincial Requirements
  2. Product Registration Testing
  3. Testing Centers
  4. Self Testing
  5. Standards
• Clinical Evaluation
  1. Clinical Trial Site
  2. IVD Clinical Evaluation
  3. Clinical Trial
  4. Medical Device Clinical Evaluation
  5. Ethical Review
  6. GCP
  7. Clinical Evaluation Exemption
• Registration & Filing
  1. Certificate Issuance
  2. Registration Dossier
  3. Reviewing Process
  4. Registration Issues
  5. Efiling (eRPS)
  6. Application Acceptance
  7. Fliing Review
  8. Supplmental Phase
  9. Pre-review
  10. Services of Documents
  11. Registration Fees
  12. QMS Inspection
  13. Master Files
  14. Expert Consultation
  15. NMPA Consultation
  16. Prioriity Approval
  17. Conditional Approval
  18. Urgent Approval
  19. IFU & Labeling
  20. Online Application
• Manufacturing
  1. Application Acceptance
  2. Certificate Issuance
  3. GMP
  4. Contract Manufacturing
• Distribution
  1. Application Acceptance
  2. Certificate Issuance
  3. GSP
  4. Advertisement
  5. Recall
• Usage
  1. Usage Management
  2. Disposable Medical Devices
  3. Adverse Events
• Supervision & Inspection
  1. Regulator
  2. Penalties
  3. Insepction Plan
  4. Insepctor
  5. Inspection Results
  6. Management Practices