Korea pushes to make domestic medical device standards become international standards

The Ministry of Food and Drug Safety has stepped up efforts to bring Korea's medical device approval standards up to international standards.

Oh Jeong-won, director of the KFDA's Medical Device Approval Division, said so at a meeting with journalists on Tuesday, explaining the ministry’s efforts to foster the Korean medical device industry.

"The number of medical device approvals continues to increase totaling 765 last year," Oh said. “About 60 percent were Class 1, 25 percent were Class 2, 10 percent were Class 3, and 4 percent were Class 4."

General medical devices are categorized into four classes based on their potential risk to humans, and in vitro diagnostic medical devices are categorized into four classes based on their potential risk to individual and public health. Medical devices with high risk are classified as Class 4, those with moderate potential risk are Class 3, those with low potential risk are Class 2, and those with little potential risk are Class 1.

The MFDS is in charge of approving Class 3 and 4 medical devices, and the National Institute of Medical Device Safety Information (NIDS) is responsible for approving Class 1 and 2 medical devices.

"With the ministry’s reorganization, the Medical Device Approval Division was officially launched in May, and the overall management of Class 1 and 2 medical devices is handled by the new division," Oh said. "The new division and NIDS have established a regular communication channel so that the division can take over the function of overseeing Class 1 and 2 medical devices more strictly."

Director Oh said his division would strive to ensure Korea's medical device standards become international standards, and the division will be at the forefront of this effort.

"We are now working on international standardization of medical device standards," Oh said. “If standards proposed by Korea become international standards, it means that standards reflecting the environment and conditions of the Korean industry will become international standards, giving us an advantage in preempting overseas markets."

There are three types of standards for medical devices: IS, an international standard; KS, a national standard; and the Medical Device Reference Standard, which is specialized for medical devices and managed by public notification.

According to the “Status of Korea's Initiative to Approve International Standards for Medical Devices,” 28 domestic standards are being approved as international standards, including performance evaluation process for artificial intelligence medical devices, general requirements for packaging of stick-type soft gels, and general requirements for transcutaneous whole blood stimulators.

Of these, two are being processed by the International Electrotechnical Commission (IEC) and 26 by the International Organization for Standardization (ISO).

“The ‘AI medical device performance evaluation process’ passed the first gateway of the IEC in November last year," Oh said. "Establishing an international standard for AI-based medical devices can lead the global market, so a public-private-academic council has been formed for the registration process."

The medical device industry also welcomed the ministry's efforts to standardize medical device standards internationally.

"The medical device industry is a regulated industry driven by regulations because using medical devices is directly related to human safety," said an official from the Korea Medical Device Industry Association. "If we lead the way in regulations, it also raises the level of our medical device companies (who have passed all the regulations)."

The official continued, “If other countries have the same regulatory standards as ours, it makes it easier to export our products to those countries, so leading the way in regulation saves us money and time."

"The industry is also feeling the efforts of the MFDS and businesses are highly satisfied with the government’s global regulatory leadership," he added.