Your technology company, Orange Peel, would like to register its new smart watch with health
sensors, including a module that performs micro-sampling of the blood through tiny capillaries
that painlessly penetrate the upper layers of the skin of the wearer. Basic measurements of key
circulating metabolite levels can be measured with this device in real time, giving the wearer and
his/her health provider real-time performance measurements of kidney and liver function.
Orange Peel is preparing STED paperwork for submission to the Australian regulatory bodies.
What information does Orange Peel need to gather for this STED file?
Question #2: Following Orange Peel’s success with its watch in Australia, the company has
decided to diversify its portfolio of smart interconnected medical devices. It has created a line of
limb augmentation exoskeleton devices for the legs that give the wearer additional contraction
strength and support. The degree of support, the speed of contraction, and other metrics, can be
controlled by the synched Orange Peel watch, and synchronized to music, external inputs, etc.
Applications range from walking assistance for the injured, infirmed, and elderly, to standing
stamina improvement for factory and fulfillment center workers.
What procedures does Orange Peel need to follow to have its robo-pants approved as
medical devices on the Chinese market? Do they need to conduct clinical trials of the
devices if they have trial results from Australia?
As head of the Regulatory Affairs Division for Orange Peel Asia, you have been tasked with
developing a regulatory strategy for marketing approval for your robo-pants in all of China,
India, and Taiwan.
What is the framework of your strategy and the milestones you will have along the way?
In conjunction with the Ministry of Public Heath in China, Orange Peel has developed a version
of its watch that detects the presence of common opioids in the blood of patients, via a
disposable add-on cartridge. The hope is to gain approval for medical use of this device to
monitor compliance in pain treatment, in order to control initial stages of potential opioid abuse.
What is the regulatory course to have the watch and disposable add-on cartridge approved
for sale on the Chinese market?