In Malaysia, the Medical Device Authority (MDA) is charged with the role of regulating medical device and its industry players.
The Medical Device Act 2012 has been gazetted on 9th February, 2012 by the Malaysian Government. The Act was effective on 1 July 2013 and undergoes a transition period before it is fully enforced in 2014. The Act specifies requirements for medical device product registration, establishment licensing and conformity assessment body (CAB) registration.
The Medical Device Regulations 2012, the subsidiary legislations under the Medical Device Act 2012, has been approved by the Minister of Health and has been published in the Gazette on 31st December 2012.
The Regulations specify requirements and procedural matters pertaining to medical device registration, conformity assessment body (CAB) registration, establishment licensing, export permit and appeal.
The Regulations was enforced simultaneously with Medical Device Act 2012 on 1st July 2013. And as specified in Medical Device Act 2012, a transition period of two years for medical device registration and one year for establishment licensing will be given to the industry before it is fully enforced.
More information is available from the MDA website.
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