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The Regulations will come into operation simultaneously with Act 737 on 1st July 2013

The Medical Device Act has been gazetted in late 2012, when will MDCD going to release the regulations, the guidelines and tell the industry the process of licencing? The industry is eager to find out. There are a lot of question which are not being answered. A statement onthe website states:

  • "The Regulations will come into operation simultaneously with Act 737 on 1st July 2013. And as specified in Act 737 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."

What it looks like is that MDCD will be ready to implement the controls starting 1st of July 2013. This date differs from their presentation of the Transition Plan at PICC, Putrajaya 28 June 2012 which shows that the Establishment Licencing would starts in Q3 of 2012. That wasassumed that the gazettement of the Bills in Q1 2012 but it did not happen. So with the delay in gazettement, the whole program has now been delayed also, this gives the medical dealers a little more time to get ready.

So it is very likely that by 1st July 2014, all medical device distributors would need to have gone through setting up the GDP process and obtained their establishment licence.

Similarly by 1st of July 2015, all medical devices would need to be registered before they can be put on the Malaysian market.

Sources from the minsitry said, the phase approach described in the Transition Plan may not be implemented but a simultaneous aproach will be adopted when the computer system which handles the administration of this process is ready.