Beginning July 1, 2013, device manufacturers marketing product in Malaysia will meet with some new requirements. Malaysia’s Ministry of Health (MOH) passed the first comprehensive legislation that required the registration of all medical devices – the Medical Device Act 2012. Manufacturers are granted a two-year transition period to register devices with the Medical Device Authority (formerly the Medical Device Control Division – MDCD) of the Malaysian Health Ministry, and a one-year grace period to comply with licensing requirements.
Manufacturers who fail to register by November 2014 will face significant fines and possibly prosecution. Registered medical device establishments must have proper procedures for recalls and good manufacturing and design standards. They must also conform to quality and safety assessment standards.
A new government agency was also created under a separate legislation, The Medical Device Authority Act. Under the new act, the MOH created a new body that would be responsible for enforcing the new regulations and promoting Malaysia’s medical device industry.
Similar to Singapore, the new Malaysian regulation includes risk-based classification of devices, use of Conformity Assessment Bodies (CAB), and Authorized Representation. A list of authorized CABs will be published online by July, and foreign manufacturers with no local presence in Malaysia will be required to appoint Malaysia Authorized Representatives to manage registrations and post-market vigilance requirements on their behalf. Licensed CABs will be responsible for reviewing and certifying applications prior to final approval from the Medical Device Authority.
Medical device registration will be completed online via submission on a Medical Device Authority website, launching in July, and the Medical Device Authority intends to make expedited review pathways available through an administrative process.
Malaysia, with a population of over 28 million, has a medical device market of more than $1 billion, which is expected to grow 15.9 percent per year through 2017.