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Hong Kong has issued new guidance and an updated code of conduct on the roles and responsibilities of entities wanting to be listed as a local responsible person.
Certain products would be upclassified under new Australian proposals.
The Therapeutic Goods Administration has released a statement on the implications of Brexit for medical devices in Australia.
4C Medical plans to conduct both an early feasibility study and the pivotal trial for its mitral regurgitation treatment device simultaneously in Japan, the US and Canada. The company says the study is the first early feasibility study in Japan for an implantable device.
The Therapeutics Goods Administration has begun a second public consultation on how it intends to improve its rules for 3D-printed and other personalized medical devices after stakeholders called for more clarification to proposals made in 2017.
Australia is proposing to introduce new medical device software rules that would result in a number of changes for industry. Health Canada, meanwhile, has developed a draft guidance for software as a medical device to better define the regulatory compliance requirements for emerging technologies.
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