NMPA published the draft version of “Clinical Trial Exemptions Catalog for Medical Devices” on July 29, 2020 for feedback. 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.
Ask us if your devices or IVDs 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.
53 medical devices (including 18 Class III devices) are added to the proposed catalog; and product names and descriptions for additional 13 medical devices are amended:
- Urinary X-ray machine
- Mobile C-arm X-ray machine
- Gastrointestinal motility marker capsule
- Baby incubator
- Baby radiant warmer
- Continuous blood purification line for single use
- Venous blood reservoir
- Metal locking bone plate
- Metal locking bone screw
- Metal interlocking intramedullary nail
- Negative pressure isolation and transportation chamber for infectious disease
- Handheld vision screener
- Intraocular Illuminator Fiber Probe
- Dental examination light
- Tooth grinder
- Endoscopic surgery power system
- Endoscopic stapler
- Medical molecular sieve oxygen system
- Aneurysm clip
- … …
15 IVDs (including 2 Class III IVDs) are added to the proposed catalog:
- Total IgE antibody detection reagent
- Specific IgE antibody detection reagent
- S100 protein detection reagent
- Anti-Mullerian Hormone (AMH) Determination Reagent
- Newborn Thyroid Stimulating Hormone Test Reagent
- Glutathione transferase detection reagent
- Glutamate dehydrogenase detection reagent
- Helicobacter pylori detection reagent
- … …
If finalized, a total of 1,055 medical devices and 416 IVDs will be exempted from clinical trials in China since the first exemptions catalog issued in 2014.
For an English copy of the draft Clinical Trial Exemptions Catalog, please email info@ChinaMedDevice.com. We charge nominal fees for the translation.
For the Clinical Trial Exemptions Catalog 2019, please click HERE.