Head of Regulatory Policy Asia Pacific, Global Regulatory Policy & Intelligence,
Chairperson, In-Vitro Diagnostics (IVD) Working Group & Vice-Chair,
Regulatory Group, Digital Health,
Asia Pacific Medical Technology Association Ltd.
Yasha Huang is currently the Head of Regulatory Policy Asia Pacific within the Global Regulatory Policy & Intelligence team at Roche Diagnostics. Yasha has extensive experiences in the health policy and she is passionate about advocating for regulatory science as well as enhancing holistic capacity building for regulatory professionals.
Prior to Roche, Yasha was most recently the Regulatory Affairs Director at APACMed, the region’s first and only MedTech industry association. Her main role was driving regulatory initiatives for patients’ better access to medical technologies, by leading the Regulatory Affairs Committee and partnering with key stakeholders including government agencies, local associations, think tanks, medical device regulatory harmonization and convergence platforms, such as the International Medical Device Regulators Forum (IMDRF), the Asian Harmonization Working Party (AHWP) conferences, and the APEC Regulatory Harmonization Steering Committee (RHSC).
Prior to that, Yasha was working at the China Food and Drug Administration (CFDA) based in Beijing, where she was actively involved in global governance and stakeholder engagement, collaborating with international organizations, government agencies, NGOs, academia, donors, and industry.
Yasha holds a Master’s Degree in Public Health from Dartmouth College, U.S. with a Fulbright scholarship. She has authored white papers and position papers in the fields of regulatory competency framework, acceptance of overseas clinical performance evaluation, regulatory agility during the pandemic, EU IVDR impact on Asia Pacific markets, etc. She is currently the Chair of IVD Working Group within RA Committee and Vice Chair of Regulatory Group within Digital Health Committee at APACMed.