Korea: New Regulations on Information Disclosure for Medical Device Manufacturers

Beginning August 31, 2012, the Korean Food and Drug Administration (KFDA) will require medical device manufacturers in Korea to disclose more product information to the public.

The KFDA has prepared a guideline on information that needs to be disclosed for medical devices. The new policy requires medical device companies to release more information on measurement characteristics, how the device operates, caution in use, expiry date, storage information, etc. In addition, the KFDA plans to push device companies to include information on product shape, structure, and raw materials in their submissions to the KFDA. These submissions will then be shared with the public through the agency website.

Along with recent revisions of the Medical Device Act in April 2012, the Korean government has been actively providing regulatory guidance to the growing local medical device market. According to the KFDA, Korea’s medical device market grew 10.3 percent in 2011, reaching $3.9 billion, larger than India’s roughly $3 billion device market. The policy changes aim to improve transparency and predictability of requirements for medical devices, expand access to safe and quality products, and promote acceptance of international standards.