MFDS Establishes Exemption Criteria for Postmarket Studies of Rare Medical Devices

The Ministry of Food and Drug Safety (MFDS) has established criteria for exempting medical devices with overseas use experience from postmarket studies, aiming to ensure a stable supply of rare medical devices and improve patient access to treatment.

On the 31st, MFDS announced a partial revision to its “Regulation on Postmarket Studies of Medical Devices.” The revision clarifies the exemption criteria for medical devices with overseas use experience and the scope of required documentation.

Postmarket studies assess the safety and effectiveness of rare and newly developed medical devices for a period of at least 4 years and no more than 7 years after they are marketed. Under Article 18 of the Enforcement Rule of the Medical Devices Act, medical devices with overseas use experience may be exempted from these studies following review by the Medical Device Committee.

The revision clarifies the definition of medical devices with overseas use experience and specifies the types and scope of documentation applicants must submit to demonstrate such experience, including overseas clinical data.

MFDS said it expects the revision to ease the burden on industry and help ensure a more stable domestic supply of rare medical devices with established safety and effectiveness, thereby improving patient access to treatment.

Details of the revised notice are available under Laws and Regulations and Data on the National Law Information Center (www.law.go.kr) or the MFDS website (www.mfds.go.kr).