South Korea has updated its medical device regulations to provide a pathway for innovative technologies such as artificial intelligence, robotics and 3D printing technology applied to medical devices.
The new regulations, which take effect on May 1, 2020, include pre-market review criteria for devices with advanced and innovative technologies, Jin-young Yang, director general of the Medical Safety Bureau of Korea’s Ministry of Food and Drug Safety (MFDS), said at the recent International Medical Device Regulators Forum in Russia.
One key aim of the legislation is to help South Korea be more competitive in the global market and to more quickly introduce innovative devices.
The new pathway includes several mechanisms for fast tracking approvals for innovative devices, including breakthrough devices that improve treatment for rare or intractable diseases, and priority reviews. The regulator provides additional support during the development and licensing phase, and the pathway includes a five-year post-market surveillance program.
The Act on Medical Devices provides a precertification application procedure, as well as a preferential R&D tax exemption for devicemakers that construct manufacturing facilities in the country.
In addition, a pre-certification program for innovative software allows devicemakers to exempt certain submission requirements by undergoing a pre-certification inspection. The program is modeled after the FDA’s precertification program.
The updated regulations split in vitro diagnostics from medical devices for the first time in South Korea, because the regulator saw the need for specific support for IVD development and commercialization, Yang said.
The ministry saw the need to verify the accuracy of IVDs that diagnose diseases and it has developed a separate management system for IVDs that harmonizes with international standards.
The MFDS defines IVDs as reagents used ex vivo for the purpose of diagnosing disease, determining tissue or blood compatibility, and using human-derived samples as specimens. IVDs are classified according to their potential risks.
The new regulation also allows for simultaneous approval of corresponding companion diagnostics and drugs.
South Korea began requiring unique device identifiers for Class IV high-risk implantable devices in July. UDIs for Class III (serious risk) devices will be required by July 2020, UDIs for Class II (potential risk) devices will be required in July 2021, and lower-class Class I devices will need to carry UDIs by July 2022.
The ministry has developed draft guidelines on developing clinical trial protocols for medical devices that use artificial intelligence. It also drafted guidelines for 3D printed personalized medical devices.