Updates on South Korean Medical Device Regulatory Changes
EMERGO SUMMARY OF KEY POINTS:
- Several South Korean medical device and IVD regulatory changes have taken effect in late December 2016 and early January 2017.
- These regulatory changes affect issues including IVD documentation requirements, medical device advertisements and MDITAC review processes.
- Premarket review fee increases have not yet been finalized by the Ministry of Food and Drug Safety, but are expected to take effect in 2017.
Enforcement dates for various new and updated medical device regulations in South Korea have now gone into effect, according to Emergo consultants in Seoul.
Current and prospective South Korean medical device and IVD market registrants should ensure that they meet these new requirements if they have not already. The South Korean Ministry of Food and Drug Safety (MFDS) enforcement dates pertain to the following regulations:
- Medical Device Act No. 1354 (link in Korean), which specifies acceptable performance test data, analytical and clinical performance tests, quality management testing and standard material and storage data to meet in vitro diagnostic (IVD) registration documentation requirements.
- Prior Review of Medical Device Advertisement No. 2017-151 (link in Korean) that requires MFDS approval of all medical device advertising prior to release and publication, even though not all such advertisements will be reviewed by the regulator.
- Guidance on Medical Device Consignment of Subject and Range of Certification and Notification No. 2016-150 (link in Korean) requiring certification of all Class II devices by the Medical Device Information & Technology Assistance Center (MDITAC) that oversees lower-risk devices in South Korea; devices identified on an exemption list included in this guidance, however, will still have to have their technical documentation undergo MFDS review.
- MFDS medical device registration review fees are expected (link in Korean) to increase two- or threefold, but so far the regulator has only issued a draft notification of these increases.