| Medical Devices | In Vitro Reagents |
| 1. Guidance on Biological Evaluation and Review of Medical Devices | 1. Technical Review Guidance Principles for Analytical Performance Evaluation of In Vitro Diagnostic Reagents (Accuracy - Methodology Comparison) |
| 2. Guidance Principles for Preparing Registration Application Materials for Drug-Eluting Medical Devices | 2. Technical Review Guidance Principles for Analytical Performance Evaluation of In Vitro Diagnostic Reagents (Accuracy - Recovery Studies) |
| 3. Guidance Principles for Defining Registration Units of Medical Devices | 3. Technical Review Guidance Principles for Registration of Nucleic Acid Amplification Detection Reagents |
| 4. Guidance Principles for Registration Review of Mobile Medical Devices (Revised Edition 2025) | 4. Technical Review Guidance Principles for Registration of Gold-Label Detection Reagents |
| 5. Guidance Principles for Technical Review of Animal-Derived Medical Devices Registration (Revised Edition 2017) | 5. Technical Review Guidance Principles for Registration of Enzyme-Linked Immunosorbent Assay Detection Reagents |
| 6. Guidance Principles for Designing Clinical Trials of Medical Devices | 6. Technical Review Guidance Principles for Registration of Biochip-Based Diagnostic Reagents |
| 7. Technical Guidance Principles for Accepting Overseas Clinical Trial Data for Medical Devices | 7. Technical Review Guidance Principles for Registration of Luminescent Immunoassay Diagnostic Reagents |
| 8. Guidance Principles for Registration Review of Medical Devices for Rare Disease Prevention and Treatment | 8. Technical Review Guidance Principles for Submission of Clinical Trial Data for In Vitro Diagnostic Reagents |
| 9. Technical Guidance Principles for Registration Review of Service Life for Active Medical Devices | 9. Technical Review Guidance Principles for Preparing Instructions for In Vitro Diagnostic Reagents |
| 10. Technical Guidance Principles for Registration Review of Customized Additive Manufacturing Medical Devices for Passive Implantable Bone, Joint, and Oral Hard Tissue | 10. Technical Review Guidance Principles for Registration Using Overseas Clinical Trial Data of In Vitro Diagnostic Reagents |
| 11. Technical Guidance Principles for Registration Review of Validation and Verification of Determination Methods for Known Leachables in Medical Devices | 11. Technical Guidance Principles for Clinical Evaluation of In Vitro Diagnostic Reagents Exempt from Clinical Trials |
| 12. Technical Guidance on Benefit-Risk Assessment for Medical Devices (Revised 2023 Edition) | 12. Registration Review Guidance Principles for Analytical Performance Evaluation of Quantitative In Vitro Diagnostic Reagents |
| 13. Guidance on Conditional Approval for Market Authorization of Medical Devices | 13. Registration Review Guidance Principles for Analytical Performance Evaluation of Qualitative In Vitro Diagnostic Reagents |
| 14. Fundamental Principles of Safety and Performance for Medical Devices | 14. Guidance Principles for Registration Review of Reference Interval Determination for In Vitro Diagnostic Reagents |
| 15. Guidance on Evaluation of Raw Material Changes for Passive Medical Devices | 15. Guidance Principles for Registration Review of Quality Control Materials—Quality Control Material Assignment Studies |
| 16. Technical Guidance on Using Real-World Data for Clinical Evaluation of Medical Devices (Trial Version) | 16. Technical Guidance Principles for Clinical Trials of In Vitro Diagnostic Reagents |
| 17. Technical Review Guidance for Registration of In-Home In Vitro Diagnostic Medical Devices | 17. Guidance Principles for Registration Review of Stability Studies for In Vitro Diagnostic Reagents |
| 18. Guidance on Safety and Efficacy Evaluation of Medical Devices Using Nanomaterials Part I: System Framework | |
| 19. Guidance on Registration Review of Animal Studies for Medical Devices Part II: Trial Design, Implementation, and Quality Assurance | |
| 20. Guidance on Registration Review of Animal Studies for Medical Devices Part I: Decision-Making Principles (2021 Revised Edition) | |
| 21. Technical Guidance on Deciding Whether to Conduct Clinical Trials for Medical Devices | |
| 22. Technical Guidance on Product Comparison Notes for Products Listed in the Exemption from Clinical Evaluation Catalog | |
| 23. Technical Guidance Principles for Equivalence Demonstration in Medical Device Clinical Evaluation | |
| 24. Technical Guidance Principles for Medical Device Clinical Evaluation (2021 Revised Edition) | |
| 25. Technical Guidance Principles for Clinical Evaluation Reports in Medical Device Registration Applications | |
| 26. Technical Guidance Principles for Submission Requirements of Clinical Trial Data in Medical Device Registration Review | |
| 27. Technical Guidance Principles for Registration Review of Drug-Device Combination Products with Predominantly Medical Device Function | |
| 28. Guidance Principles for Registration Review of Drug-Device Combination Products with Predominantly Medical Device Function: Qualitative and Quantitative Analysis of Drugs and In Vitro Release Studies | |
| 29. Guidance Principles for Drafting Technical Requirements for Medical Devices (No. 8, 2022) | |
| 30. Guidance Principles for Registration Review of Cybersecurity for Medical Devices (Revised Edition, 2022) | |
| 31. Guidance Principles for Safety and Efficacy Evaluation of Medical Devices Incorporating Nanomaterials Part II: Physical and Chemical Characterization | |
| 32. Guidance Principles for Evaluation of Recombinant Humanized Collagen Raw Materials | |
| 33. Technical Guide for Electronic Submission of Medical Device Registration Applications (Trial) | |
| 34. Guide for Preparing Priority Review Application Materials for Medical Devices (Trial) | |
| 35. Guide for Preparing Application Materials for Special Review of Innovative Medical Devices | |
| 36. Technical Guide for Compliance with Essential Principles of Safety and Performance for Medical Devices | |
| 37. Guidance Principles for Preparing Instructions for Use of In Vitro Diagnostic Reagents (Revised Edition 2023) | |
| 38. Guidance Principles for Registration Review of Key Raw Materials for In Vitro Diagnostic Reagents | |
| 39. Guidance Principles for Registration Review of Real-World Research Design and Statistical Analysis for Medical Devices | |
| 40. Guidance Principles for Stability Studies of Passive Implantable Medical Devices (Revised Edition 2022) | |
| 41. Guidance Principles for Registration Review of Laparoscopic Surgery Systems Part 2: Decision Criteria and Requirements for Animal Testing | |
| 42. Guidance Principles for Registration Review of Medical Device Optical Radiation Safety | |
| 43. Guidance Principles for Registration Review of Medical Device Usability Engineering | |
| 44. Guidance Principles for Registration Review of Single-Use Sterile Surgical Packages (2024 Revised Edition) | |
| 45. Guidance Principles for Safety and Efficacy Evaluation of Medical Devices Incorporating Nanomaterials Part III: Biocompatibility and Toxicological Evaluation | |
