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MCRA Presents on Medical Device Regulation to Chinese FDA

Musculoskeletal Clinical Regulatory Advisers (MCRA), a leading advisory firm and clinical research organization serving the medical device industry, delivered an informational presentation on April 16 about U.S. medical device regulations to 22 members of the Center for Medical Device Evaluation of the China Food and Drug Administration (CFDA) in Beijing, China.

The session explored U.S. device regulations and offered 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 Justin Eggleton, Senior Director of Regulatory Affairs. He 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.

“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,” Eggleton said.

Source: Musculoskeletal Clinical Regulatory Advisers