India’s Central Drugs Standard Control Organization (CDSCO) has released the final list of risk classifications for oncology-related medical devices. The classification system, published on January 2, 2026, improves transparency concerning the regulation of cancer med-tech devices. It gives manufacturers of oncology devices clear guidance on the level of regulatory oversight required based on their device’s intended use and level of risk. The list includes devices such as accelerator system components and alternating electric field cancer treatment systems. These devices are classified across risk tiers to align with India’s MDR 2017 framework. The CDSCO has stated that the risk classification system will continue to evolve over time.
China’s National Healthcare Security Administration has completed its sixth national bulk procurement of high-value medical devices. This round of procurement selected 440 products from 202 manufacturers. It expanded coverage of cardiovascular devices and, for the first time, included tools for urinary stone surgeries. Drug-coated balloons and core urology devices such as guidewires and balloon dilation catheters were added. This move is expected to significantly reduce treatment costs, particularly for minimally invasive kidney stone procedures. The program also introduced safeguards against excessively low bids while supporting quality and innovation. Patients should be able to access the newly procured, lower-priced devices from around May 2026.
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.