Shanghai Attorneys Author Publication on China’s New Medical Device Regulations
Life sciences regulatory & compliance partner Katherine Wang and associate Tina Wu (both of Shanghai), in collaboration with executives from McKinsey & Company, have authored a publication titled Building a “Healthy China” Through Innovation and Compliance.
The authors explain that amid a rapidly changing and complex business and regulatory environment, China’s medtech policymakers are striving to find the right balance between accelerated market access of innovative products to satisfy diverse clinical needs and enhanced emphasis on product quality and safety. The article offers perspectives on how to achieve the balance in three critical areas: clinical evaluations, product standards and personal liability.
The authors express confidence that the new Medical Device Regulations will find the right balance to reward innovation, provide regulatory and enforcement policies to deter misconduct and enable business development of China’s medtech industry.