【CMDE】 The Medical Device Evaluation Center released 10 guidance principles for medical device registration review

Recently, the Medical Device Evaluation Center of the National Medical Products Administration issued 10 guiding principles for medical device registration review, covering orthopedic implants, oral repair membranes, etc.To further standardize the management of medical devices such as type I collagen cartilage repair products, the Medical Device Evaluation Center of the National Medical Products Administration has organized the formulation and revision of 10 guidance principles for the registration review of medical devices, including the “Guidance Principles for the Registration Review of Type I Collagen Cartilage Repair Products” , which are hereby issued.

1.Guidance Principles for the Registration Review of Type I Collagen Cartilage Repair Products

2.Guidance Principles for Registration Review of Antibacterial Performance Evaluation of Orthopedic Implants

3. Guidance Principles for the Registration Review of Absorbable Intramedullary Fixation Implants

4.Guiding Principles for the Registration Review of Oral Repair Membranes

5.Guidance Principles for the Registration Review of Metal Bone Needles

6. Guidance Principles for Registration Review of Memory Alloy Rib Plates

7. Guidance Principles for the Registration and Review of the Sternum Strapping and Fixation System

8. Guidance Principles for the Registration and Review of Skull Repair Mesh Plate Systems

9. Guidance Principles for Product Registration Review of Dental Resin Filling Materials (2025 Revised Edition)

10. Guiding Principles for the Registration Review of Oral Bone Filling Materials for Implantology