Did you watch Entrapment, the Sean Connery and Catherine Zeta-Jones thriller movie from the end of the last millennium? The movie took place in Kuala Lumpur, a global city and the capital of Malaysia.
Malay is the national language in four countries, Brunei, Malaysia, Indonesia and Singapore with over 270 million native Malay speakers and a total GDP of about $1.5 trillion US in 2014.
Malaysia is a relatively open state-oriented and newly industrialized market economy with GDP growing an average 6.5% annually. In 2014 it contributed half of the above $1.5 trillion GDP number and expected to grow to $1.2 Trillion US by 2050!
The overall infrastructure of Malaysia is one of the most developed in Asia. With the aim of developing Malaysia into a medical tourism destination, 5% of the government social sector development budget is spent on healthcare.
Malaysia is a member of the Association of Southeast Asian Nations (ASEAN). In Malaysia, general medical and IVD devices are regulated by the Medical Device Authority (MDA) of the Ministry of Health. The regulatory framework is based on the Medical Device Act 2012 (Act 737) and Medical Device Regulations 2012. The legislation came into effect on July 1, 2013. Prior to that time, there was a voluntary registration system in place.
Malaysian Medical Device Regulations
Prior to entering the Malaysian medical device market, a medical device company should first determine whether its product is considered a medical device. Secondly, the device’s risk classification will need to be established. The definition of a medical device is very closely aligned with the EU definition.
Medical devices in Malaysia are classified as Class A (exempt), Class A (active/sterile/measuring), Class B (low to moderate risk), Class C (moderate to high risk), and Class D (highest risk), similar to the classification scheme used in the European Medical Device Directive (MDD) 93/42/EEC.
If a device has been approved in one of the recognized reference markets of the US, Europe, Australia, Japan, and/or Canada, the manufacturer will be able to leverage this approval and complete a simplified Conformity Assessment Body (CAB) review.
Medical Devices Labeling Requirements in Malay Language
All application documents can be submitted in English. However, the use of Malay is required for labeling of home-use medical devices. Labeling for professional-use only devices can be in English only.
In general, an EU label can be used (with accurate translations) with the addition of the term “Registered with MDA,” as well as the contact information of the Malaysia Authorized Representative.
Why Translate into Malay Now?
In July 2013, a new mandatory medical device regulatory system came into effect in Malaysia. The Medical Device Act 2012 forms the basis of the regulations, overseen by the Medical Device Authority, the MDA. The Malaysia medical device regulatory system is still very much in development and new guidance documents are being released at regular intervals. Manufacturers of medical devices who are planning to continue or start taking their products to Malaysia must submit an application for medical device registration before June 30, 2016. Failure to do so might lead to significant delays.
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