News Update - 12-07~12-13

Department

Update

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CMDE

Notice on Soliciting Public Comments Regarding the Draft Guidance Principles for Registration Review of Anesthesia Reservoir Products and 23 Other Class II Medical Devices

Abstract:

1. Anesthesia Reservoir Bag Products

2. Single-Use Sterile Ophthalmic Passive Surgical Instruments

3. Endoscopic Curettes

4. Custom Orthodontic Appliances

5. Dental Implant Surgical Guides

6. Temporary Crowns and Bridges

7. Glass-Ceramic Blocks for All-Ceramic Dentures

8. Surgical Retractors

9. Hemostatic Bandages

10. Neonatal Oxygen Masks

11. Single-Use Umbilical Cord Scissors

12. N-Acetyl-β-D-Glucosaminidase Detection Reagents

13. Clinical Evaluation of Medical Dressings of the Same Variety

14. Orthopedic External Fixation Braces

15. Zirconia Blocks for All-Ceramic Dentures

16. Custom-made dentures

17. Bone cement sleeve assemblies

18. Single-use medical laryngeal masks

19. Surgical gauze dressings

20. Anastomosis (suture) devices

21. Single-use suction catheter products

22. Umbilical cord protectors

23. Nasogastric feeding tubes

24. Single-use sterile urinary catheters

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Notice on Soliciting Public Comments Regarding Two Medical Device Registration Review Guidance Principles, Including the “Guidance Principles for Registration Review of Glaucoma Drainage Devices for Implantation in Minimally Invasive Glaucoma Surgery (Draft for Comment)”

Abstract:

1. Guidance Principles for Registration Review of Glaucoma Drainage Devices for Implantation in Minimally Invasive Glaucoma Surgery

2. Guidance Principles for Registration Review of Central Venous Catheters

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Notice Regarding the 55th Offline Training Session of the “Cloud Classroom for Device Review”

Abstract:

Wednesday, December 17, 2025, 13:30–16:10

1. Introduction to the Technical Review Guidance Principles for Balloon Dilatation Catheters

2. Introduction to the Registration Review Guidance Principles for Vascular Interventional Devices with Lubricating Coatings

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What specific measures has the Medical Device Evaluation Center implemented to support the review and approval of medical devices for the prevention and treatment of rare diseases?

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What are the primary scenarios for which the “Key Points for Reviewing AI-Based Process Optimization Functions in Medical Imaging Ultrasound” apply? What other scenarios can be referenced?    

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What are the requirements for clinical trial documentation related to companion diagnostic reagents developed concurrently with anticancer drugs?    

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NIFDC

China National Institute for Food and Drug Control Seeks Public Comments on Instructions for 11 National Standard Materials and Reference Materials for In Vitro Diagnostic Reagents Used in Registration Testing  

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Summary of the Third Medical Device Product Classification Results for 2025

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Summary of the Fourth Medical Device Classification Results for 2025

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SAC

Announcement Regarding the Accreditation of Inspection Qualifications for the New Version of the GB 9706 Series Standards (December 2025)

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