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.
Ask us if your devices are in the Catalog. Even if not, we can develop clinical evaluation strategy to help you avoid the expensive and time-consuming clinical trial. info@ChinaMedDevice.com.
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.
For English version of the Clinical Trial Exemptions Catalog, please email info@ChinaMedDevice.com. We charge nominal fees for the translation.
For our comments on 2018 Exemptions Catalog, please click HERE.
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About ChinaMed Device, LLC
ChinaMed Device, LLC (www.ChinaMedDevice.com) provides regulatory and commercialization turnkey solutions for medical device, IVD, CDx and combination products in China. As a qualified NMPA (CFDA) legal agent with offices in Boston and Beijing, we can represent manufacturers for the complete product life cycle without their need to create a local entity in China. Our NMPA (CFDA) regulatory services include strategy, registration, local type testing, product technical requirement (PTR), clinical evaluation report (CER), clinical trial, GMP and post-market surveillance (AE, recall, inspection, etc.). Our commercialization services include market research, reimbursement, partnership strategy and distribution qualification.