MCRA Offers Informational Presentation on Medical Device Regulation to the Chinese FDA

NEW YORK, Dec. 18, 2017 /PRNewswire-USNewswire/ -- Musculoskeletal Clinical Regulatory Advisers, LLC (MCRA), a leading advisory firm and Clinical Research Organization (CRO) to the medical device industry, is pleased to announce that it delivered an informational presentation about United States Medical Device Regulations to delegates of the China Food and Drug Administration (CFDA) from Jiangsu province.


The meeting took place on December 14th between nineteen delegates of the CFDA and MCRA. It was a learning opportunity for both parties to understand the similarities and differences in medical device regulation between the two countries. The session aimed to collaboratively explore U.S. device regulations and offer high-level knowledge about the FDA review process. MCRA's experts were led by Senior Vice President of Clinical and Regulatory Affairs, Mr. Glenn Stiegman. He shared insights and experience on key regulatory topics while providing a comprehensive overview of the necessary regulatory processes involved when introducing medical device technologies to the U.S. market. An interactive Q&A session provided an opportunity for Chinese officials to explore particularities and nuances of various regulatory pathways and submissions as well as FDA Inspections on manufacturing and contractor facilities.

When opening the floor to questions and discussion, Glenn Stiegman said, "MCRA is honored to be able to have a discussion with CFDA delegates. MCRA sees this as an opportunity for both parties to learn from each other, learn about our experiences with medical devices, our success stories, and challenges. MCRA's hope is that the CFDA benefits from our shared knowledge helping device companies identify and manage the opportunities and challenges in today's global marketplace."

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About MCRA

Founded in 2004, Musculoskeletal Clinical Regulatory Advisers, LLC (MCRA) is a leading adviser and clinical research organization to the neuro-musculoskeletal and orthopedic industry. MCRA's value lies in its industry experience and integration of five business value creators: regulatory, reimbursement, clinical research, healthcare compliance and quality assurance. MCRA's integrated approach of these key value creating initiatives provides unparalleled expertise for its clients. MCRA has offices in Washington, DC, Manchester, CT and New York, NY, and serves nearly 500 clients globally.


David W. Lown
General Manager
212.583.0250 ext. 2111