Analysis of New Draft Regulation for Medical Devices in South Korea
Emergo consultants in Seoul have conducted a thorough analysis of draft Ministry for Food and Drug Safety (MFDS) revisions to South Korean medical device and IVD regulations announced earlier in 2015 to highlight major changes between current and proposed new requirements.
The draft Enforcement Regulation on Medical Devices Act (link in Korean) covers a broad array of South Korean medical device and IVD compliance areas, including medical software, clinical study requirements, biocompatibility testing and distribution. Below, we highlight some of the major changes the draft regulations would entail.
Clinical requirements for high-risk devices
The draft regulations would expand clinical trial data for many Class IV high-risk medical devices. Specifically, devices meeting the following characteristics would fall under the new requirements:
- Devices used to sustain human life
- Implantable or invasive devices
- Devices made using special materials (vivo-derived or antibiotic materials, for example)
- Absorbable devices
Biocompatibility test requirements
Under the draft regulation, biocompatibility testing rules would be loosened compared to existing requirements. Now, MFDS will only accept Good Laboratory Practice (GLP) test reports from GLP-accredited laboratories.
The draft requirements would allow South Korean regulators to accept biocompatibility test data from either Organization for Economic Co-operation and Development (OECD) member countries or non-OECD member countries that apply OECD GLP standards.
Medical device software requirements
Under existing MFDS requirements, medical device registrants must provide information on any embedded software or algorithm used in their products, as well as the major function of software components. The draft regulation would require registrants to disclose the structure and major function of any software used as part of or in conjunction with their devices.
Furthermore, registrants currently must report model numbers or names, versions, operating environment and related information on any software either embedded in their devices or used independently; according to the draft requirements, registrants would have to provide the name and version of software, but would also have to provide the software’s operating environment if it is used independently.
In addition, the draft MFDS requirements would require reports from registrants on their medical device software so that the regulator could perform compatibility checks.
Class I device applications and MDITAC
One of the more significant changes in the draft MFDS regulation is the registration pathway for Class I medical devices. Under current rules, registrants whose devices fall under Class I classification in South Korea submit notification applications to local MFDS offices; those applications are considered accepted once they are registered on the MFDS website, and commercialization of those products can begin.
The new regulation would establish a new office, the Medical Device Information & Technology Assistance Center or MDITAC, to which Class I notifications would be submitted. MDITAC would then register those applications on its website, signaling to registrants that their devices could then be sold in South Korea.