China’s digital health regulatory framework for software as medical device (SaMD) has continuously been evolving with several important legislative developments over the years overseen by the China National Medical Products Administration (NMPA).
Hamish King, COO at Cisema, wrote an article recently on China’s digital health regulatory framework for SaMD for featuring on the weekly newsletter of the Regulatory Affairs Professionals Society (RAPS). The article is based on a presentation conducted by Hamish at the RAPS 2022 Convergence in Phoenix, Arizona during September 11-13, 2022. As a RAPS member and also certified by RAPS with the RAC qualification, Hamish actively presents in seminars and webinars for RAPS and other global exhibitions or trade fair events such as MEDICA in Messe Dusseldorf.
RAPS is the largest global organization of and for those involved with the regulation of healthcare and related products, including medical devices, pharmaceuticals, biologics and nutritional products. Founded in 1976, RAPS helped establish the regulatory profession and continues to actively support the professional and lead the profession as a neutral, non-lobbying nonprofit organization. RAPS offers education and training, professional standards, publications, research, knowledge sharing, networking, career development opportunities and other valuable resources, including Regulatory Affairs Certification (RAC) credentials, the only post-academic professional certifications to recognize regulatory excellence. RAPS is headquartered in suburban Washington, DC, with chapters and affiliates worldwide.
Click here to read the article on China’s digital health regulatory framework for SaMD.
Or if you are a member of RAPS, you may click here to read the original article featured on RAPS.
Focusing on latest regulatory hot topics and developments in China, Cisema annually presents over 70 public seminars, webinars, trainings and workshops for clients and industry in association with government, export agencies, seminar providers, conferences, trade associations and partners. Feel free to contact us if you are interested to carry out an in-house seminar with our regulatory specialists tailored to your requirements.