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APAC

Door closed

The door to Europe is closed – so where else should I look?

By Arthur Brandwood | 12.02.2019
Early in 2019, the European commission was promising that by end of year MDR implementation would be well underway. There would be substantial numbers of Notified Bodies designated to perform...
Hong Kong

Hong Kong Regulatory Processes Overview

By Jean Boudaud | 12.18.2018
Regulatory System Medical Device regulations and import in Hong Kong operates under its own framework, controlled by the Medical Device Control Office (MDCO), a division of the Department of Health...

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Recent Posts

A single review program for medical devices?

Dec 2, 2019

The door to Europe is closed – so where else should I look?

Dec 2, 2019

Are Harmonised Standards facing irrelevance?

Nov 4, 2019

The question on clients’ lips… “How long will my application take?”

Nov 4, 2019

TGA Publishes updated MDIR Guide

Oct 31, 2019

EU Software Classification under MDR/IVDR – New Guidance Document

Oct 28, 2019

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