China NMPA issued 30 guidelines in July 2023, to guide manufacturers for local type testing, pre-clinical, clinical studies, and regulatory submissions. Some of the key areas covered in the review points and guidelines are included in the following:
1. Key review points for ultrasound imaging artificial intelligence software (process optimization)
2. Key review points for performance evaluation on artificial intelligence analysis software for pathological images
3. Key review points for clinical evaluation on artificial intelligence analysis software for pathological images
4. Key review points for performance evaluation on artificial intelligence analysis software for blood disease flow cytometry
5. Key Review Points for Animal testing of extracorporeal membrane oxygenation (ECMO) consumable products
6. Guideline on continuous glucose monitoring system
7. Guideline on blood thawing device
8. Guideline on respiratory humidifier
9. Guideline on intestinal hydrotherapy machine
10. Guideline on molecular sieve oxygen generator
11. Guideline on bladder ultrasound scanner
12. Guideline on single-use peritoneal dialysis catheters
13. Guideline on respiratory filters
14. Guideline on oropharyngeal/nasopharyngeal airway
15. Guideline on liquid dressings
16. Guideline on gel dressings
17. Guideline on β-hydroxybutyric acid detection reagent
18. Guideline on methotrexate detection reagent
19. Guideline on anti-cyclic citrullinated peptide antibody detection reagent
20. Guideline on Gram-positive bacteria identification reagent
21. Guideline on transcatheter aortic valve system
22. Guideline on vascular intervention devices with lubricating coatings
23. Guideline on non-vascular self-expanding metal stent system
24. Guideline on medical device product benefits – risk determination
25. Guideline on extracorporeal membrane oxygenation (ECMO) temperature control equipment (draft)
26. Guideline on mobile ECG atrial fibrillation testing products
27. Guideline on insulin pumps
28. Guideline on high-flow respiratory therapy equipment
29. Clinical evaluation guideline on predicate comparison of ventilators
30. Clinical evaluation guideline on predicate comparison of hip prostheses
Out of 30 review points and guidelines, only "Guideline on extracorporeal membrane oxygenation (ECMO) temperature control equipment" is the draft version, and the rest are the final one.
Areas to pay attention to:
If your product changes before the renewal, the manufacturer needs to apply modification on permission items to NMPA first.
In general, the parallel guidelines will be released right after the standards. If it is the first registration of your product, the manufacturer needs to comply with the latest guidelines.
If your product is undergoing changes, upgrades, or renewal and is related to the latest guideline mentioned above, please assess whether an upgrade testing is required to comply with the latest requirements of NMPA.
If your products are impacted by the guidelines update or have any questions, please email me.
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Grace Fu
China Med Device, LLC
MA, U.S.
gpalma@ChinaMedDevice.com978-390-4453
www.ChinaMedDevice.com------------------------------