MIPM takes off in South Korea

Since 2016, MIPM has been active in South Korea with a local partner on site. When new approval requirements were published by the South Korean authorities in 2017, there was great hope that the high European standards would be accepted. However, in mid-2019, the sobering news came: the European approval was not sufficient, and new requirements had to be implemented. No one could have anticipated how challenging this would be. The first difficulty was obtaining a quality management certificate according to Korean regulations (Korean Good Manufacturing Practices KGMP). This requirement culminated in a four-day certification by the South Korean authorities in Mammendorf, conducted entirely in Korean.

The long-awaited certificate finally arrived in December 2019. However, suddenly this certificate, which qualifies MIPM as a manufacturer of medical devices, was no longer sufficient. The Korean authorities demanded specific tests to comply with the changed South Korean regulations. Desperation spread at MIPM. But the approval experts did not give up. After extensive tests and lengthy correspondence, the approval for the TeslaM3, which has been on the market since 2013, was granted in South Korea in December 2020. Not only was Lukas Spögler, responsible for international approvals at MIPM, relieved. "The registration in South Korea not only brought language barriers but also new technical challenges to our patient monitor," said Lukas Spögler. Therefore, the joy was even greater when the registration was finally completed. Spögler, who is currently handling 12 new approvals worldwide for MIPM, is dealing with various authorities from all over the world. MIPM GmbH now invests more in approval processes than in the development of its own devices. The Regulatory Affairs department has gained immense importance at MIPM in recent years, which is reflected not only in the increased costs but also in the personnel requirements.