On January 15, Singapore’s Health Sciences Authority (HSA) and the Indonesian Food and Drug Authority signed a Memorandum of Understanding (MoU) to improve regulatory cooperation. Both agencies have obtained the World Health Organization (WHO) Listed Authority status, which confirms that they have met the highest international regulatory standards as mandated by WHO. The two health authorities will work together to share information on drugs and complementary health products, including collaborative evaluation of products, clinical trial regulation, emerging technologies, staff training, and post-market safety. The MoU will enable both agencies to respond to health risks in a timely manner, strengthen both authorities’ capabilities, and make it easier for businesses seeking to establish new products in Singapore and Indonesia.
In January, Korea issued a new regulation that allows for significantly faster entry for innovative medical devices into the Korean market than has been possible in the past. The Ministry of Health and Welfare (MOHW) and the Ministry of Food and Drug Safety (MFDS) announced the program called “Market Immediate Entry Medical Technology,” which enables healthcare facilities to begin using new innovative medical technologies immediately after receiving approval from the MFDS. As a result, innovative devices can enter the market in as little as 80 business days. Devices that have been evaluated by the MFDS through an enhanced clinical evaluation will no longer require a separate New Medical Technology Assessment. 199 medical device categories, including in vitro diagnostics (IVDs), digital medical devices, and robotic medical devices, qualify for this pathway. The government believes this new regulatory approach will assist with faster patient access to new technologies while protecting patient safety through enhanced clinical evaluation during the approval process.
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.