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CFDA Gives Approval To China’s First Domestically Produced Pacemaker By a China-Overseas Joint Venture


China Approves the Rega™ Line of Pacemakers

CFDA said YES to the Rega™ line of pacemakers, China’s first domestically manufactured pacemakers that meet international standards. This product is manufactured in China by MicroPort Sorin Cardiac Rhythm Management Co. Ltd. (“MSC”), a join venture between LivaNova and China’s MicroPort Scientific. It is believed that Rega pacemakers are the smallest on the Chinese market today, with advanced functions and features such as  pacing mode that preserves intrinsic conduction, a dual sensor based response rate to exercise and sleep apnea monitoring.

According the company executives, China has more than one million patients who can be treated with an implantable pacemaker, with an estimated 300,000 new cases annually. Due to the current high price of pacemakers in China, only about 80,000 patients are able to receive a pacemaker implant annually.


About China Med Device, LLC (CMD) CMD provides turn-key solution for Western medtech companies with regulatory and commercialization services. CMD helps its clients accelerate China entry and growth by offering: market Intelligence and research; CFDA regulatory services (premarket submission, clinical evaluation, clinical trial design & management, post market compliance and legal representation), and other commercial services. If you have an inquiry or feedback regarding our services please email us at

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