What are the key digital health trends in China? How does risk class classification for the NMPA (former CFDA) work? Are there any fast-track regulatory pathways? What are the latest updates regarding digital health regulations? We’ll answer all of these questions and more during our webinar with Cisema, a CRO and regulatory consultancy for China. Hamish King, Chief Operating Officer of Cisema, will present market opportunities and regulatory implications of the fast-growing digital health care sector in China. Join us on Tuesday, May 25 from 11:00 am - 12:00 pm ET to become better equipped to access China’s digital health market. Register now.
Agenda topics will include:
- Recent updates on the digital health care sector in China
- Regulatory pathways for medical devices and IVDs with the China National Medical Products Administration (NMPA, formerly CFDA)
- Cybersecurity updates
- SaMD registration in China
- Alternative regulatory pathways
Hamish King, Chief Operating Officer, Cisema
Hamish King is COO at Cisema, a China-focused CRO and regulatory consultancy founded in Munich and Beijing in 2002. A lawyer by training – admitted in Hong Kong and NSW, Australia – Hamish supports companies with difficult regulatory affairs queries for China. Formerly with UK Magic Circle Firm Linklaters in Hong Kong, he has nearly 10 years' experience in the legal and regulatory fields and has obtained the RAC and CFA qualifications. Regularly writing articles and speaking on China market access and regulatory pathways, he currently lives in Hong Kong and specializes in NMPA registration of medical devices. Hamish has a close interest in the regulatory implications of digital healthcare and AI applications.
Anna King, Business Consultant, Cisema
Anna attained degrees with distinction in Natural Sciences (BSc) and China Business (MSc) in England and Hong Kong after growing up in Beijing, China for the first 5 years of her life before schooling in Germany. She has been working for Cisema group since 2013 and is advising companies on China certification as a business consultant of Cisema in Munich, Beijing and Hong Kong. Anna currently resides in Hong Kong and specializes in NMPA (former CFDA) registration of medical devices.
Arthur Ng, Business Development Officer, North America, Cisema
Arthur attended SUNY in the United States. Upon completing his studies in the US, he worked for various companies ensuring they met regulation requirements of CPSC, OSHA, and ANSI. His responsibilities also included the supervision that regulatory guidelines set by agencies such as UL, TUV, IEC, and CE were strictly adhered to. After 30 years working in the USA, he relocated to Hong Kong to have greater oversight of manufacturing facilities in China to ensure they were following all regulatory standards as required per country. Arthur supports medical devices manufacturers in US & Canada experience a smooth and efficient registration process for their devices in China.