Greetings and Welcome
Greetings and welcome to the official website of the Medical Device Authority (MDA).
MDA is a statutory body under the Ministry of Health Malaysia which was established under the Medical Device Authority Act 2012 (Act 738) to control, regulate medical device, its industry and activities as well as to enforce medical device law under Medical Device Act 2012 (Act 737). Prior to the enactment of Act 738, the Medical Device Control Division (MDCD) of Ministry of Health Malaysia was entrusted to develop the medical device regulatory program, including the drafting of medical device law. Subsequent to the gazettement of Act 738, MDA was formed in May 2012 (and MDCD ceased to operate). Officers and staffs of the then MDCD were transferred to MDA in June 2012.
It has come a long way since the time the regulatory program was first proposed in 2005 until the date when Act 737 finally comes into effect on 30 June 2013 and then followed by the effective date of Medical Device Regulations 2012 on 1 July 2013. The regulatory reform started with the determination of policies, study on regulatory practices in established countries, engagement with stakeholders and coming up with an appropriate regulatory model for Malaysia. The regulatory model was developed based on best regulatory practices and is consistent with the global harmonised model. It has two main aims, namely to protect public health and safety and to facilitate medical device trade and industry.
With the effective dates of Act 737 and Medical Device Regulations 2012, the medical device industry has now progressed from unregulated environment to a regulated one and the industry players must observe all the applicable regulatory requirements stipulated by the Authority under Act 737. However, as provided in Section 80, Act 737 offers a transition period of two years and one year respectively for the industry to submit applications for medical device registration and establishment licensing before the law is fully enforced.
" BERILTIZAM PENUHI HASRAT "
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