How MDA Assists Companies For Medical Device Approval

The Medical Devices Authority has developed 21 circulars, 39 regulation documents and seven guidelines on the Medical Device Act.

KUALA LUMPUR, May 23 – The Medical Devices Authority (MDA) has prepared documents, circulars, guidelines, and legal requirements to assist companies to comply with regulations on medical devices.

These documents are intended for the companies to comprehend their involvement in the medical device industry and facilitate obtaining approval from the regulatory agency.

Senator Hajah Zurainah Musa had asked the Ministry of Health (MOH) to state the steps taken by MDA in facilitating companies to obtain advisory services for the required medical device approvals.

“This is to ensure the availability of medical device facilities for the people is not affected,” Hajah Zurainah stated in her Dewan Negara question on March 24.

To date, a total of 21 circulars, 39 regulation documents and seven guidelines have been developed to provide detailed explanations on various aspects of the implementation of the Medical Device Act 2012 (Act 737) and regulations under it.

Act 737 regulates any medical devices placed in the Malaysian market to ensure high quality, effective and safe products for the public.

“In addition, MDA also offers advisory services through various platforms, consultation sessions, live inquiries via email and telephone as well as seminars, workshops and training aimed at providing understanding and facilitating companies to obtain MDA approval,” Health Minister Khairy Jamaluddin mentioned in a written parliament reply on March 24.

A total of 40 consultation sessions and 16 seminars or training, have been implemented in 2021 including those related to the Covid-19 test kit which was the focus and this has been implemented since 2020 after the pandemic hit the country.

“MDA plans to hold 19 seminars or training and 40 consultancy sessions throughout 2022.”

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