First approval in China

During an on-site visit in Beijing, the groundwork for approval was laid. Andreas Klement, Vice President at MIPM, clarified outstanding issues directly with the CFDA (China Food and Drug Administration). The authority is responsible for the approval of medical technology products in China, including the patient monitors developed and produced at the Mammendorf Institute for Physics and Medicine (MIPM GmbH).

"Our monitors TeslaM3 and TeslaDUO are already recognized and approved by the internationally accredited CB testing institute. However, China tests according to its own standards," explains Vice President Andreas Klement. MIPM also has a representative in China, but some technical questions remained, which Andreas Klement answered for the CFDA inspector with the help of an interpreter. The information is now being summarized and documented again. MIPM has been working on approval in China for three years in total. "A long, but usual period for such procedures," assures Andreas Klement. Such processes not only tie up financial resources but also personnel in all areas. Therefore, MIPM is always looking for new employees.

If nothing significant happens, the approval for the TeslaDUO should be achieved in a few weeks. In Mammendorf, they are confident that this milestone will be reached by the end of March, allowing MIPM to operate in China with almost no competitors. The plan is to exhibit at the CMFE trade fair in Shanghai in May, thus giving the go-ahead for the sale of the TeslaDUO in China. The approval for the TeslaM3 is expected in the third quarter of 2019.

In addition to Beijing, Andreas Klement traveled to Shanghai. At XinHua Hospital, he accompanied the commissioning of a surgical MRI system focused on neuro-oncological operations. The system is used to remove brain tumors. Such a procedure can take up to ten hours, during which the MIPM patient monitor TeslaM3 reliably monitors all vital functions of the patient.