Micren Healthcare Co., Ltd. Professional Representation Service for Medical Device in the Japanese market

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Micren Healthcare is acquired by EP Mediate;



Strengthens Its Position Japan DMAH Service Provider

Micren Healthcare Co., Ltd., has been acquired by EP Mediate Co., Ltd., which is a subsidiary of the leading Japanese CRO, EPS Holdings, Inc.

Micren Healthcare provides professional and independent Designated Marketing Authorization Holder (DMAH) and In-Country Caretaker (ICC) for clinical trial services for medical devices and holds a Type I Medical Device Marketing Authorization Holder license. “We have seen an increase in clients of novel medical devices including in genetic testing, SaMD with AI and deep learning technology which most often require clinical data in support of obtaining device approvals in Japan”, said Michiharu Miyahara, President of Micren Healthcare. “Combining EP Mediate and Micren Healthcare capabilities will allow for a broader service offering to our DMAH clients in particular in the area of clinical studies and investigation.”.

EP Mediate provides CRO services, including clinical studies and investigation, post-market clinical studies and regulatory consulting to predominantly Japanese medical device companies and subsidiaries of foreign medical device companies located in Japan. “With the acquisition of Micren Healthcare we will bring in more in-depth expertise and experience working with international companies and will increase our inhouse global regulatory capabilities by offering assistance with clinical investigation, regulatory device submissions, insurance reimbursement strategy and submission, and post approval services such as importation, release judgment, vigilance works and reporting.” said Masanori Tanji, President and Representative Director of EP Mediate.

The stock purchase agreement was made on June 18, 2021 and the completions of this acquisition has been set for June 30, 2021.

Please visit www.micren.co.jp to learn more about Micren Healthcare and www.ep-mediate.co.jp to learn more about EP Mediate.