- India’s DCGI, on January 6 revised the device classification of 4 main device categories. These categories include 186 interventional radiology devices, 114 radiotherapy devices, 75 Oncology devices, and 803 Class A Non-Sterile and Non-Measuring devices. Please remember that India classifies medical devices in Rule 4(3) in Chapter 2 of the 2017 MDR. This is a risk-based system. Industry stakeholders are invited to respond and comment on these changes in the next 30 days. Feedback can be given online through this Google form link.
- Taiwan’s National Health Insurance system will now include more surgical robotic products as of March 1, 2025. While Taiwan’s health insurance program already covered radical prostatectomies and partial nephrectomies, they will now cover 17 different types of robotic surgery. The big winner here is Intuitive Surgical that has been selling its units in Taiwan since 2004.
- Malaysia is currently experiencing a 12.5% inflation in healthcare costs. To help reduce very expensive private health expenditures, Malaysia plans to implement a diagnosis-related group system (DRG) next year.
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.