The session aimed to collaboratively explore U.S. device regulations and offer high-level knowledge about the FDA review process. MCRA attended along with its partner, China Med Device, LLC, a Chinese market focused integrated advisory firm. MCRA was represented by Mr. Justin Eggleton, Senior Director of Regulatory Affairs. Mr. Eggleton shared a comprehensive overview of the regulatory processes for introducing medical device technologies to the U.S. market, insights on key regulatory topics, and case studies within the neuro-musculoskeletal industry. An interactive Q&A session provided an opportunity for Chinese officials to explore the many complexities and nuances of the various regulatory pathways.
Justin Eggleton said, "MCRA is honored to be invited by the CFDA to discuss the medical device regulation process in the U.S. This discussion allowed MCRA and the CFDA to gain a deeper understanding of the challenges faced when trying to maintain an active and healthy regulatory system able to keep pace with innovation. Further, as a firm that provides integrated support for companies entering international markets, it is crucial for opportunities such as these to ensure we have direct access and knowledge of the current regulatory environment. China is the 2nd largest medical device market with double digit growth now.” MCRA General Manager, David Lown commented “The mutual communication and dialogues will enhance the understanding of both countries regulatory challenges and facilitate the adoption of innovation more efficiently and effectively towards the international standards in the neuromuscular sector."
For more information on MCRA, please visit www.mcra.com
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. MCRA has a demonstrated history of driving success in all areas of the medical device industry including spine, orthopedics, cardio-vascular, diagnostic imaging, endoscopy, ophthalmics, general/plastic surgery, drug delivery, wound care, diabetes, dental, general healthcare, nephrology, neurology, cardiology, and in vitro diagnostic (IVD) devices.
David W. Lown
General Manager, MCRA, LLC
Phone: 212.583.0250 ext. 2111