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Welcome  Message - KAMI SEDIA MEMBANTU

Greetings and welcome to the official website of the Medical Device Authority (MDA).

 
The MDA website contains a wealth of information about medical device and its regulatory control for the benefit of the consumers, patients, medical device industry - namely manufacturers, authorised representatives of foreign manufacturers, importers, distributors, conformity assessment bodies, medical professionals and public as a whole.

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.

Medical devices encompass a wide array of products with myriad use ranging from simple contact lenses to precise robotic arm and sophisticated computed tomography machines, orthopaedic implants and heart valves. We presume that when we open the “gate” for registration and licensing, the volume of applications would be very massive. To manage these applications more efficiently and effectively, MDA has developed an application system, called “Medical Device Centralised Online Application System” (“MeDC@St”), as a platform for the industry to submit applications for registration of medical devices and licensing of establishments under Act 737. MeDC@St is a fully web-based online application system which enables the industry players to submit applications from anywhere in the world. MDA has engaged the industry players in the design and development of MeDC@St and with all its features, we envisage MeDC@St would be a user-friendly and robust platform for registration and licensing activities.

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.

The industry players are also urged to start making early applications to licence their establishments and to register their medical devices.

 " BERILTIZAM PENUHI HASRAT "

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