South Korean health authorities are slashing the amount of time required to approve new medical devices before they can be brought to market in the country. The shorter approval period, announced on July 19 by Korea's Ministry of Food and Drug Safety (MFDS), is part of a series of measures instituted over the past year to deregulate and promote the medical device industry. The new regulatory system will permit new devices classified as safe to go on sale before they undergo government safety evaluations. This will cut the approval period for the devices from a maximum of 390 days to just 80 days.
Pacific Bridge MedicalSince Pacific Bridge Medical (PBM) was founded in 1988, we have assisted hundreds of healthcare companies with business development and regulatory issues in Asia. In addition to our expert staff in the D.C. area, PBM has its own offices in China, Japan, Singapore, and Hong Kong and affiliates in India, Indonesia, Korea, Malaysia, Philippines, Taiwan, Thailand, and Vietnam, who help our clients to develop business and regulatory strategies, register products, increase sales, perform market research, and more. For more information, visit www.pacificbridgemedical.com.------------------------------
Ames Gross
President
Pacific Bridge Medical
Bethesda, MD
www.pacificbridgemedical.comcontact@pacificbridgemedical.com------------------------------