ISRAEL EXPORT INSTITUTE

China’s Digital Healthcare Opportunities and Regulatory Implications

Calendar
Outlook Google (online)

03

November
2020
Full Dates
03
November
Tuesday

Type

Business Meetings

Sectors

Medical Device & Digital Health

Event Code

11052

Location

וירטואלי

Contact us for more details and prices

More Information

China’s Digital Healthcare Opportunities and Regulatory Implications

Expand All

China’s Digital Healthcare Opportunities and Regulatory Implications

+

AGENDA:

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.

Time

Nov 3, 2020 10:00 AM in Jerusal

For Regisration Click Here

Contact us

I confirm receipt of direct mail from the Export Institute
FullNameNotTyped PhoneNotTyped SubjectNotSelected

Thank You!

טעינה