China Life Sciences Attorneys Co-Author Whitepaper on Public Private Collaboration to Advance Medtech Regulatory Reform
Life sciences partner Katherine Wang and life sciences senior international associate Tina Wu (both of Shanghai) co-authored a whitepaper titled “Public Private Collaboration to Advance Medtech Regulation Reform.” The paper was produced with input from Florian Then, Kevin Wu and Wei Wei of McKinsey & Co.
China’s National Medical Products Administration (formerly known as the CFDA) introduced a series of transformative initiatives to reform the Medtech regulatory system in 2017 and 2018. Regulatory affairs leaders in the Medtech industry have welcomed these changes. Medical device standards, clinical evaluation, and product classification are three areas where the public private collaboration model can add value. This paper reviews the current state in these areas, proposes recommendations, and discusses a successful example of public private collaboration.