On July 1 of this year, new medical device regulations will go into effect in Malaysia. Once the new regulations are enacted, manufacturers will have two years to register with Malaysia’s Medical Device Authority (MDA). The MDA is also known as the Medical Device Control Division (MDCD).
There are many significant similarities between the new regulatory guidelines in the country and those that are currently used in Singapore. Emergo Group, a global medical consultancy, prepared a list of the key components of the new regulatory framework. The following text comes from the Emergo Group’s website:
(from Emergo Group)
Risk-based classification of devices:
Class A (lowest risk),
Class B (low to moderate risk),
Class C (moderate to high risk)
Class D (highest risk)
According to Emergo Group, there will also be licensed Conformity Assessment Bodies in the new Malaysian framework. The authorized CABs will be in charge of the certification and reviewing of medical device applications prior to total approval by the MDA. If a manufacturer has no local presence in the country, it will be required to appoint specialized representatives, dubbed Malaysia Authorized Representatives, for the management of post-market vigilance requirements and registrations.
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