Home > Property & Casualty > New trial regulations for medical device makers in South Korea

New trial regulations for medical device makers in South Korea

sKoreaThe Ministry of Food and Drug Safety  (MFDS) will implement new clinical trial regulations for certain high risk medical devices looking to obtain trial approval. The agency announced last October that beginning in 2014, 68 devices (those that are either transplanted or absorbed into the human body) must submit trial data as part of technical documentation before receiving approval to conduct trials.

The MFDS, formally known as the Korea Food and Drug Administration, is a South Korean government agency that oversees the safety and efficiency of foods, pharmaceuticals, medical devices and cosmetics and supports the development of the food and pharma industries.

The new law states that foreign manufacturers (including those in the United States) seeking trial approval may still submit trial data from overseas. However, the MFDS can request additional trials be conducted in Korea if the data does not meet requirements for approval. The policy was formed as part of an amendment to the Enforcement Rules of the Medical Devices Act and is expected to become effective within a year of being publicized. Implementation plans could change, however, the Korea Medical Devices Industry Association has requested a two year grace period.

Insurance coverage for clinical trials in South Korea is compulsory/  Should a manufacturer be required to conduct a clinical trial in South Korean, the insurance must be provided by a local insurer and the premium paid locally.  Coverage becomes effective the date after payment is received.  Manufacturers should keep these requirements in mind if planning to seek approval in South Korea.

WGA will continue to monitor the status of the law and will provide timely updates.


About the Author

Amy Sinclair is an Executive Vice President and co-leader of the Life Sciences Practice in WGA’s Property and Casualty Group. She negotiates, implements and manages comprehensive insurance programs for a variety of clients, ranging from venture-backed start-up organizations up to publicly traded companies.

617.646.0229 | Asinclair@wgains.com | Connect with Amy on LinkedIn
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