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Asia Pacific

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Hong Kong Clarifies Rules On Local Responsible Persons To Facilitate Device Listings

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.

Hong Kong Regulation Medical Device

Australia Reviews Device Classification Rules To Align With EU

Certain products would be upclassified under new Australian proposals.

Australia Europe

‘No Deal’ Brexit? Australia Will Still Accept UK Notified Body Certificates

The Therapeutic Goods Administration has released a statement on the implications of Brexit for medical devices in Australia.

Australia Brexit

4C Medical Plans First Early Feasibility Study For An Implantable In Japan

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.

Japan Canada

Global Medtech Guidance Tracker: February 2019

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Twenty-six new guidance documents have been posted on the tracker since its last update.
Regulation Medical Device

Australia Tries Again At Tightening Personalized And 3D-Printed Device Rules

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.

Policy & Regulation Australia

Software: Australia Plans Reforms While Canada Consults On Guidance

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 Health Canada, meanwhile, has developed a draft guidance for software as a medical device to better define the regulatory compliance requirements for emerging technologies.

Canada Australia
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