On September 18, 2021, NMPA has released measures for medical devices and IVD respectively. According to the Measures for Registration and Filing of Medical Devices and Measures for Registration and Filing of In-vitro Diagnostic Reagents, NMPA has formulated the Catalogue of Medical Devices Exempted from Clinical Evaluation and the Catalogue of In-vitro Diagnostic Reagents Exempted from Clinical Trials, covering 1010 items of medical device products and 423 items of in-vitro diagnostic reagent products. Both of catalogues shall come into force as of October 1, 2021.
Some items are added to the catalogue. For example, the plasma surgical electrode can be exempted from clinical evaluation, which will definitely help the related manufactures to expedite their China registration. If you want to find out whether your product is on the clinical exemption list, please contact us (info@inspirativemed.com) for more information.
