Background

MDA is the government agency entrusted to serve the Malaysia medical device’s industry. It is a federal statutory agency under the Ministry of Health Malaysia to implement and enforce the Medical Device Act 2012 (Act 737). The main objectives of the Act are to address public health and safety issues related to medical devices and to facilitate medical devcie trade and industry.

In February 2005, the Cabinet approved the proposal for the development and implementation of medical device regulatory program. Subsequent to the Cabinet decision, Medical Device Authority Act 2012 (Act 738) and Medical Device Act (Act 737) have been published in the Gazzete on 9th February 2012.

MDA was established under the Act 738 on 15 March 2012 and has been officially and fully in operation since 16 June 2012.

 

Act 738 & Act 737

The Medical Device Act 2012 (Act 737) is an Act to regulate medical device, the industry and to provide for mattes connected thereto. This Act specify requirements on registration of medical device and conformity assesment body (CAB), licensing of establishment who import, export, and place medical device in Malaysia market, surveillance and vigilance of medical device and usage of medical device.

Meanwhile, the Medical Device Authority Act 2012 (Act 738) was approved to give power to the Minister to establish an agency or a body corperate to implement and enforce the Act 737 to ensure  medical devices in Malaysia market are of high quality, effective and safe to use by the public. A body corporate is named as “ Medical Device Authority (MDA)”

In conclusion, Act 738 establishes the MDA which is to control and regulate medical device, the medical device industry and its activities and to enforce the medical device laws, and for related matters.

While Act 737 is an Act to regulate medical devices, the industry and to provide for mattes connected thereto.

To protect the public health and safety, the MDB strives to ensure that medical devices in Malaysia are of high quality, effective and safe. In doing this, we play an important role and contribute to the quality of the healthcare system in the country. Thus, these two acts is very important to ensure our core business become reality.

 

FUNCTION OF MDA

• Registration of medical device
• Registration of CAB
• Issuance of Establishment License
• Issuance of  Free Sales Certificate  and Manufacturing Certificate
• Training & Awareness