After three years of COVID-19 has come to an end, NMPA announced the "2023 National Inspection Plan for Medical Devices" on March 31, 2023. The Plan mandates provincial NMPA offices and testing centers to conduct quality inspections based on Mandatory Standards and Product Technical Requirements (PTRs).
The List of 2023 Inspection Plan Medical Devices
The plan covers 68 medical devices and IVDs. The plan lists institutions and procedures for inspection, retesting and appealing. The inspection items for each type of device are listed below:
1. ECG machine
2. Mobile C-arm X-ray machine
3. Endoscope
4. ALDH2 gene test kit
5. Septin9 gene methylation assay kit
6. Treponema pallidum antibody test kit (immunochromatography)
7. Hepatitis B virus core antibody detection kit (colloidal gold method)
8. Hepatitis C virus (HCV) antibody test kit (colloidal gold method)
9. C-reactive protein assay kit
10. Homocysteine detection reagent
11. Biofeedback therapy devices
12. Weight loss gait training system
13. Intense pulsed light therapy device
14. Contrast injection device
15. Infusion pump
16. Electric gastric lavage machine
17. Non-absorbing polymer ligation clip
18. Suction catheters for the respiratory tract
19. Nd: YAG laser treatment machine
20. Baby phototherapy equipment
21. Soft contact lens
22. Ureteral stent
23. Medical sodium hyaluronate gel
24. Scar repair product
25. Single-use sterile surgical membrane
26. Ultrasonic Doppler flow analyzer
27. Ultrasonic bone densitometer
28. Ultrasound therapy equipment
29. Ophthalmic ultrasound diagnostic equipment
30. Ophthalmic ultrasound surgical equipment
31. Gynecological ultrasound diagnostic equipment
32. Therapeutic ventilator (life support)
33. Vascular stents
34. Hip prosthesis – femoral stalk
35. Hip prosthesis – acetabular cup
36. Knee prosthesis – femoral condyle
37. Spine plate
38. Spinal rods
39. Spinal screws
40. Intervertebral fusion device
41. Vertebroplasty balloon
42. And more…
Mandatory Standards
Whether manufacturers are renewing or submitting new registrations, your medical devices need to meet requirements of new mandatory standards. Even if your renewals (required by NMPA every 5 years) have no changes, you still must prove that your originally approved products can meet the new standards' requirements. As a result, your originally approved products will still need to go through local type testing to show that you follow the new standards' requirements.
If you have any questions about the National Inspection Plan or any challenge for your product registration in China, please let me know.
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Grace Fu Palma
ChinaMed Device, LLC
MA, U.S.
gpalma@ChinaMedDevice.com978-390-4453
www.ChinaMedDevice.com------------------------------