On October 9, 2017, Medical Device Authority (MDA) Malaysia released a Second Edition of the Guidance Document on Change Notification for Registered Medical Device. This GD serves a great purpose in informing the stakeholders on the categories of changes, notification process and relevant requirements for applying for a change notification in Malaysia.
More On 13 November 2017, Medical Device Authority (MDA) released the Medical Device (Declaration) Order 2017, which comes into operation on 1st of January, 2018. In this order, the MDA declares “Non-Corrective Contact Lenses”, also commercially known as “Cosmetic Contact Lenses”, as legitimate medical device.
More Recently, there have been a string of announcements released by the Malaysian Medical Device Authority to provide clear guidelines on certain matters. Following this, the MDA has released a new Guidance Document on Conformity Assessment for Medical Device that are yet to be registered.
More Malaysia’s healthcare system consists of two tiers: a state-owned universal healthcare system for national citizens runs alongside a private sector that serves international patients. Due to projected demographic shifts – chiefly Malaysia’s ageing population, increasing life expectancy and the growth of non-communicable diseases – demand for medical device is expected to grow.
More Malaysia’s MDA published a new regulation on 25th July, 2017. From the publication, there are two significant changes:
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