On May 13, China’s NMPA promulgated a new list of medical devices exempt from clinical trials. This new list, an update to the 2023 list, identifies 27 medical devices, including seven Class 3 products and 20 Class 2 products. In total, 1047 medical devices have now been excluded from clinical trials for product registration. The new regulation is called the Clinical Evaluation Exempt Catalogue for Medical Devices. If a clinical trial is not required for product registration, normally, a CER is required.
Also, in late March, the Center for Medical Device Evaluation, under the Chinese NMPA, announced more active guidance on innovative device approval. The goal of this new legislation is to speed up the review of innovative devices to fulfill unmet needs, while increasing the scrutiny of non-innovative medical devices. Medical devices with novel technologies, with enhanced safety and efficacy, will be designated as innovative. Strong clinical trial data will need to be shown to qualify as an innovative device. The Innovative Review Office’s goal will be to announce its decision on whether their device is innovative or not within 60 days of receiving the application. Acceptance rates for innovative designation for foreign-made devices are still a big challenge.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.