South Korea′s Ministry for Food and Drug Safety (MFDS) announced major changes in its medical device regulations that also, and primarily, concern the certification of Class I and II medical devices. In the future, manufacturers will have to prove compliance with the Korean Good Manufacturing Practice (KGMP) before they can apply for registration. Further changes concerning medical devices will come into effect on July 29, 2015.
Low-risk medical devices will fall under the responsibility of a new MFDS authority, the Medical Device Information & Technology Assistance Center (MDITAC), in the future.
All changes at a glance
So far, each manufacturing site has needed a separate manufacturer′s license, i.e. each manufacturing site has had to undergo a KGMP audit. In the future, manufacturers will need only one license and consequently require only one KPMG audit and/or certificate.
The former 2-license system will be replaced by a 4-license system:
From July 29, 2015
Applicable to manufacturers of products of all risk medical devices 1. Manufacture product license 2. Import product license
Applicable to manufacturers of high-risk Class III and IV medical devices 1. Manufacture license issued by MFDS 2. Import license issued by MFDS
Applicable to manufacturers of low- to medium-risk Class I and II medical devices 3. Manufacture product certification by MDITAC 4. Import product certification by MDITAC
Manufacturers must submit a certificate of their quality management system before they can apply for registration.
In case that manufacturers cannot apply and/or register the product to MFDS: Medical devices that are essentially similar to any medical device that had its registration withdrawn by MFDS cannot be registered for one year from the date of withdrawal of registration of the original device. Medical devices made of materials that pose safety and efficacy problems cannot be registered either. In both cases MFDS will not accept any application for registration.
Disposable medical devices must be clearly identified as such, with information such as “Disposable product” and “Not reusable” provided on primary and secondary packaging.
Medical devices that are already registered in Korea but have been changed need MFDS approval before they can be placed on the market.
If the use of a medical device can cause serious side effects, including death, individuals potentially at risk must be informed and a product recall planned and initiated if necessary.
Responsibilities will be re-assigned. While responsibility for the certification and registration of Class I and II devices will move to MDITAC (a department within MFDS) in the future, responsibility for the registration of high-risk products (Classes III and IV) will continue to stay with MFDS.
Update IVD registrations
Effective from May 2014, in vitro diagnostics (IVD) have been considered medical devices instead of medicinal products. Consequently, IVD manufacturers and importers need KGMP certification and must re-certify and/or re-register their IVD as medical devices. The law provides for a transitional period up to November 10, 2015, for medical devices in classes III and IV and up to November 11, 2016. for medical devices in classes I and II.