NMPA (CFDA) published "Clinical Trial Exemptions Catalog for Medical Devices (Draft)" on August 1, 2019. It is an effort to implement risk-based clinical evaluation, and to make medical device clinical exemptions more consistent with internationally-accepted standard, NMPA stated in the notice. It also calls for manufacturers' opinion on the clinical exemption status.
The draft Catalog added exemptions for 142 medical devices, including 40 Class III:
- Venous intrahepatic puncture
- Infusion catheter
- Contrast balloon catheter
- Disposable hemodialysis tubing
- Radiation protection glasses
- Dental medullary material
- Metal materials for 3D-ptinting dental device
- In vitro assisted reproductive fluid
- ……
It added exemptions for 42 IVDs, including 14 Class III:
- Cocaine detection reagent
- Morphine detection reagent
- Tetrahydrocannabinol acid detection test
- Amphetamine detection reagent
- ......
If implemented, a total of 996 medical devices and 420 IVDs will be exempted from clinical trials in China since the first exemptions catalog in 2014.
If you want an English copy of the draft Clinical Trial Exemptions Catalog or want to know if your devices & IVDs fall into the exempt category, please leave your comments here or email me at gpalma@ChinaMedDevice.com.
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Grace Fu Palma
ChinaMed Device, LLC
MA, U.S.
gpalma@ChinaMedDevice.com978-390-4453
www.ChinaMedDevice.com------------------------------