Korea has become an official member of the International Medical Device Regulatory Forum (IMDRF), which will likely help increase the nation’s medical device export, the Ministry of Food and Drug Safety said Monday.
IMDRF, established in 2011, is a group of medical device regulatory authorities to accelerate and harmonize international medical device regulation.
IMDRF member countries account for 85 percent of the global medical devices market, according to the ministry. Korea is the 10th country to join the group after the U.S., EU, Canada, Australia, Japan, China, Brazil, Russia, and Singapore, the ministry said.
The accession, realized four years ahead of schedule, is expected to contribute significantly to the Moon Jae-in administration’s plan to find and foster new high value-added industries, the ministry said. It will also elevate the country’s status on the international stage, helping Korea play a leading role in establishing and revising regulations of medical devices, it added.
"The IMDRF membership is the fruit of constant enthusiasm and drive of medical equipment manufacturers to achieve international harmonization in spite of difficult circumstances and the government’s efforts to develop the domestic medical device industry,” said Minister of Food and Drug Safety Ryu Young-jin. "We will continue to work to assist the domestic medical devices in entering the global market."
The IMDRF membership also complements previous efforts by the ministry to increase its medical device export, such as active participation in the Asian Harmonization Working Party, according to the ministry.
<© Korea Biomedical Review, All rights reserved.>