China medical device registration review guidelines released for 27 products in September 2022

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.