Asia Regulatory Forum Update
This article was originally published in Clinica
Executive Summary
Three upcoming medical device regulations were discussed at BSI’s Hong Kong Forum in April that will be important to the success of Hong Kong’s voluntary regulatory system, the Medical Device Administrative Control System.
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Saudi Arabia adopts interim device authorisation regulation
Saudi Arabia has adopted an interim marketing authorisation regulation under which, possibly as early as 2010, only medical devices that have been approved by the Saudi Arabia Food and Drug Administration will be allowed on the market1. Additionally, only medical devices that comply with the regulations in force in the European Union, the US, Canada, Japan or Australia – ie in the jurisdiction of a Global Harmonization Task Force founding member - will be eligible for marketing in the country2,3.
Canada takes action to increase more adverse event reporting
The government of Canada has launched a marketing campaign to encourage consumers and healthcare professionals to use the country’s MedEffect initiative for reporting suspected adverse events related to healthcare products1.
UK MHRA confirms medical device fee increases
The UK Medicines and Healthcare products Regulatory Agency has confirmed the levels of fees it will charge medical device companies and notified bodies for some of its medical device regulatory activities in 2009-101. The new fees are due to come into effect on 1 April, pending parliamentary approval.