MeDC@St 2.0

MeDC@St is a web-based Online Application System for Establishment Licensing, Medical Device Registration and Export Permit. It is a centralized system where only one account needs to be created by an applicant to apply for Establishment Licensing, Medical Device Registration Permit.



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 device 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 Gazette on 9th February 2012. MDA was established under Act 738 on 15 March 2012 and has been officially and fully in operation since 16 June 2012.



The Medical Device Act 2012 (Act 737) is an Act to regulate medical device, the industry and to provide for matters connected thereto. This Act specifies requirements on registration of medical device and conformity assessment body (CAB), licensing of an establishment who import, export, and place the medical device in Malaysia market, surveillance and vigilance of medical device and usage of the 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 corporate 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 matters 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 are very important to ensure our core business become reality.