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| Advanced medical devices In summary, Hong Kong universities and enterprises can focus on
Visions for the HK-SZ Collaborative Ecosystem in Biotech
prototype development, with the Hong Kong side taking charge of
Another major priority is advanced medical devices, which utilise medical engineering and the Shenzhen side concentrating on
AI technology to substantially improve surgical accuracy. HK-SZ computing and programme development. For Class II or III
collaboration in advanced medical devices can fully integrate medical devices, enterprises can, upon completion of preclinical
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and unleash Hong Kong’s medical advantages and Shenzhen’s research, conduct clinical trials in Hong Kong’s specialty
expertise in AI. With a strong record in medical research, departments or clinical trials centres that are recognised by major
Hong Kong has an edge in medical device development, and has drug regulators around the world. Similarly, for subsequent
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long provided clinical advice on medical devices like MRI and CT. quality management, Hong Kong can focus on hardware
Hong Kong is therefore well-positioned to design and develop verification and validation while Shenzhen can conduct software
clinical medical devices and take charge of quality management testing. Finally, enterprises can enjoy expedited approval for
later. Meanwhile, home to top-notch AI companies like Tencent production and product registration in the Mainland via the
and DJI, Shenzhen has formidable expertise in software NMPA’s GBA sub-centre for the Approval and Inspection of
development technology and quality management; Shenzhen also Medical Device Technology in the Shenzhen park. Commercial
boasts enterprises with strong experience in medical devices like production may commence in either Hong Kong or Shenzhen after
Mindray Medical. An enterprise that installs itself in the Loop can approval is granted.
therefore leverage the two cities’ talent pool and industrial
advantages, as well as the comprehensive development and
supply chain in advanced medical devices. Also, as illustrated
above, given that Hong Kong’s clinical trial prowess is highly
recognised and that medical device development requires fewer
study participants compared to drug development, clinical trials for
medical device products can also be conducted in Hong Kong
after the design process is completed.

36 There are generally three classes of medical devices: Class I devices are low-risk devices that are usually unregulated; Class II devices are intermediate-risk devices, and they can be
registered to enter the market by means of notification to the NMPA, with only a few requiring the submission of clinical trial data; Class III devices are high-risk devices regulated by the
NMPA that requires the submission of clinical trial data.
37 In the absence of legislation governing the regulation of medical devices in Hong Kong, enterprises can elect to apply for recognition by choice.
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