Registration of medical devices is not yet required by the Malaysian Ministry of Health. However, the Malaysian government is reviewing the Medical Devices Bill in September, 2011 and Parliament is expected to pass the Bill. If passed, new medical device regulations would likely go into effect sometime in 2012.
The new Bill would eventually require medical device registration for all classes of medical device products imported or sold in Malaysia. Medical device products will be classified as Class A, B, C, or D products, with Class A products being the least risky, and D products being the riskiest.
It is important to note that even if the new medical device regulations go into effect in 2012, the Medical Device Bureau (MDB) in Malaysia is expected to implement registration requirements in five different phases. For instance, the MDB may not require Class D medical device registration for another 2 years or so. Moreover, there is currently no transitional registration process in place, so medical device companies cannot register their product earlier even if they wanted to voluntarily.
As these are new regulations, the above information is subject to change. Pacific Bridge Medical recommends checking back regularly to keep informed about new updates on the implementation of new medical device regulations from the Malaysian government.