More Class III, Class II Medical Devices and IVDs Exempted from Clinical Trial

9 Clinical Trials Have Compliance Issues in NMPA Inspection
December 14, 2018

More Class III, Class II Medical Devices and IVDs Exempted from Clinical Trial

NMPA published the final version of “Clinical Trial Exemptions Catalog for Medical Devices” on December 20, 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.

NMPA consolidated manufacturers’ opinion on the Draft Clinical Exemption issued on August 1 2019, and amended it to the final version.

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 Catalog added exemptions for 148 medical devices (including 40 Class III devices) and amended product names and descriptions for 48 medical devices:

  • 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 23 IVDs (including 15 Class III IVDs), and amended product names and descriptions for 4 IVDs :

  • Cocaine detection reagent
  • Morphine detection reagent
  • Tetrahydrocannabinol acid detection test
  • Amphetamine detection reagent
  • ……

A total of 1002 medical devices and 401 IVDs are 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.

There were Class III IVDs exempted from clinical trial, for the first time, in 2018. 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.