MedExel Obtains MDSAP Certification, Aiming for Global Market Expansion
On the 3rd of this month, MedExel Co., Ltd. (CEO: Kim Hee-nam), a domestic manufacturer of diabetes consumables, announced that it had acquired MDSAP certification to expand its presence in global markets.
Although MDSAP may sound unfamiliar in Korea, it is highly recognized internationally, as it includes two of the top five countries in the global imported medical device market: the United States, which is overwhelmingly first in the imported medical device market, along with Japan, Australia, Canada, and Brazil. The program is attracting more countries interested in joining.
The Medical Device Single Audit Program (MDSAP) is a quality system compliance assessment program involving Australia, Brazil, Canada, the United States, and Japan. With MDSAP certification, companies can avoid separate licensing processes in these five countries.
Kim Jong-chul, the manager responsible for MedExel, emphasized, “For example, Canada replaced its CMDCAS certification with MDSAP starting January 1, 2019, making it difficult to enter the Canadian market without MDSAP. Additionally, companies with MDSAP certification can be exempt from regular FDA inspections in the U.S.”
South Korea is also working to become the sixth country to join MDSAP, while countries like China, Singapore, and Russia are showing interest in joining as well.
Shin Ja-ui, Executive Director of MedExel, added, “We are not stopping here. Our mid-to-long-term goal is to enter the Russian and CIS markets by 2022, and we have already begun registering medical devices in Russia this month.”
