China medical device registration guidelines have been updated by the National Medical Products Administration’s (NMPA) Center for Medical Device Evaluation (CMDE) to standardize the management of 27 products.
These 27 new medical device registration guidelines impact not only new registrations but also registration renewals and modifications and they came into effect on September 15, 2022.
Applicants should refer to the new guidelines when preparing and writing medical device registration declarations. The guidelines equally provide a reference for the NMPA’s CMDE when reviewing new registration applications or applications for renewal or for modifications.
List of the 27 updated medical device registration guidelines
1. Guidelines for Registration of Fibrin Monomer Determination Reagents
2. Guidelines for Registration of Disposable Incision Protective Cover Products
3. Guiding for Registration of Electro-Acupuncture Therapeutic Apparatus Products
4. Guidelines for Registration of Disposable Sterile Urine Drainage Bags
5. Guidelines for Registration of Vascular Clip Products
6. Guidelines for Registration of Scar Repair Materials
7. Guidelines for Registration of Estradiol Detection Reagents
8. Guidelines for Registration of Prealbumin Detection Reagents
9. Guidelines for Registration of Glycated Hemoglobin Analyzers
10. Guidelines for Registration of Disposable EEG Electrodes
11. Guidelines for Registration of High-sensitivity Cardiac Troponin Detection Reagents
12. Guidelines Registration of Medical Air Compressor Units
13. Guidelines for Registration of Medical Sterile Ultrasound Couplant
14. Guidelines for Registration of Medical Protective Clothing Products
15. Guidelines for Registration of Cyclosporine and Tacrolimus Detection Reagents
16. Guidelines for Registration of Heart-Type Fatty Acid Binding Protein Assay Reagents
17. Guidelines for Registration of Non-Chronic Wound Applicators
18. Guidelines for Registration of Disposable Surgical Caps
19. Guidelines for Registration of Medical Infrared Forehead Thermometers
20. Guidelines for Registration of Acid Oxidation Potential Water Generators
21. Guidelines for Registration of Shortwave Therapeutic Apparatus
22. Guidelines for Registration of Fecal Calprotectin Detection Reagents
23. Guidelines for Registration of Medical Center Oxygen Supply System
24. Guidelines for Registration of Dental Sandblasting Powder
25. Guidelines for Registration of Fungi (1-3)-β-D Glucan Assay Reagents
26. Guidelines for Registration of Oral Retainer Registration Review
27. Guidelines for Registration of Dental Root Canal Lubricant Cleaners
Further information
Please click here for the latest medical device and IVD registration guidelines.
If you would like to know how the changes affect your medical device or IVD registrations, renewals or changes, or for details of our registration and CRO services for pharmaceuticals, medical devices, IVDs, cosmetics, health foods, and industrial or consumer goods, please contact us.
