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o The rise of China’s digital economy in healthcare:
- The broader China health opportunity set
Telehealth, telemedicine, internet hospitals and distance health services – what are they and what are we seeing in China?
- Digital therapeutics and diagnostics, and AI-assisted and deep learning growth areas – what are they and what are we seeing in China
o What are the regulatory implications?
- Starting point is still the traditional classification rules for Life Sciences products in China
- Regulatory developments adapting to the digital economy:
software as medical device (SaMD)
software in a medical device (SiMD)
Deep-learning and AI products
Universal Device Identifiers (UDI)
Some digital developments at the regulator: online applications and certificates
o But, conversely the strengthening of some on-site, in-person requirements such as overseas factory inspections
o Increasing focus on PMS requirements, adapting to full product lifecycle regulation
- Legal agent role importance
o Increased emphasis on regulatory fast-track for innovative products, although not all the hype is justified:
- Hainan Boao Lecheng International Medical Tourism Zone
- Green pathway for innovative medical devices
- Registration through Hong Kong and Greater Bay Area / Pearl River Delta
o where are the regulatory gaps?
- Keeping software and AI-registrations current: due to the continual update process of digital products, the legacy regulatory frame
Brief About Cisema:
Cisema is a turn-key regulatory affairs solutions provider for China and Hong Kong for medical devices, IVDs, pharmaceutical packaging & APIs and other life science products. Founded in 2002 in Munich, Germany and Beijing, China, we have offices globally. We’re a one-stop service provider supporting Israeli and global companies register their products for sale in China (including clinical studies). Cisema also provides post-market surveillance support and can act as legal agent.
Nov 3, 2020 10:00 AM in Jerusal
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