Aidahwaty M Olaybal has won Best Woman Leader of the Year Award

Aidahwaty M Olaybal has won Best Woman Leader of the Year Award

• May 14, 2025

First of all, I would like to take this opportunity to thank my parents for always believing in me and helping me achieve more in everything I do. A big thank you to my husband and my sons, who are my pillars and supporters, helping me achieve my dreams. I also want to thank my CEO, Dr. Muralitharan, for always trusting me to do my best in my work accomplishments.

I am Aidahwaty M. Olaybal, 48 years old, married with two sons. I am from Kota-Kinabalu, Sabah, Malaysia. I graduated in Applied Physics in 2001 from the National University of Malaysia before pursuing my master's in Biomedical Engineering at the University of Surrey, UK, in 2008.

I am over the moon to be chosen for this prestigious award. It is truly an honour to be recognized as one of the achievers in this esteemed group. This acknowledgment not only validates the hard work and dedication I've put into my personal and professional life, but it also inspires me to continue striving for excellence. I am grateful for the opportunity to be part of an initiative like 'Women Icon powered by Times Women,' which celebrates the triumphs of women around the world. This recognition serves as a reminder of the importance of perseverance, resilience, and the power of leading by example. I hope to inspire other women to chase their dreams and make a lasting impact on their communities.

My involvement in developing the Regulatory Framework on Medical Devices in Malaysia began in 2004. It started when I joined the Medical Devices Core Team to identify the best practices for regulating medical devices and benchmark approaches to develop the Medical Device Act to be enforced in Malaysia.

In 2012, the Medical Device Act 737 was officially gazetted by the Parliament of Malaysia, marking a significant milestone in the regulation of medical devices within the country. This Act became mandatory for enforcement in July 2013, ensuring that all medical devices meet stringent safety and effectiveness standards before entering the market. Alongside this legislative development, the Medical Device Authority (MDA) was established in the same year to oversee the enforcement of Act 737. Currently, MDA, under the capable leadership of Dr. Muralitharan as its CEO, began its operations with a dedicated team of 173 staff members.

Since the inception of the MDA, I have played a vital and instrumental role as a regulator within the organization. My responsibilities include meticulously ensuring that all medical devices placed in the Malaysian market are thoroughly registered and comply with the established regulations. This process is crucial for guaranteeing the safety and effectiveness of these devices, thereby protecting the health and well-being of the Malaysian population. My work at the MDA has been driven by a commitment to uphold high regulatory standards and contribute to the advancement of medical technology in Malaysia.

My current role as the Director of the Pre-Market Control Division encompasses the important function of controlling pre-market activities before devices can be placed in the Malaysian market. Pre-market activities such as issuing Establishment Licenses to companies dealing with medical devices, assessing and approving medical devices before they can be marketed, and registering Conformity Assessment Bodies (CABs) are among the pillars of pre-market activities.

On average, the MDA receives about 19,000 applications for medical device registration each year, with around 17,000 applications being approved annually. It is important for us to process the applications accordingly to ensure all safety evidence is addressed before the applications are approved. By processing the applications within the specified turnaround time, we ensure that new technologies are made available to the public in a timely manner.

Internationally, my involvement in the Global Harmonization Working Party (GHWP) for the Southeast Asia Region, where I have been elected as the chairman for Working Group 5 (WG5) on Clinical Evidence of Medical Devices, provides me with a platform to promote the harmonization approach among global regulators regarding the acceptability of clinical evidence of medical devices. In the future, I plan to continue my global involvement to enhance my contribution while carrying Malaysia's name as a well-known and recognized regulator internationally.

It is important to establish Malaysia as a recognized country globally. This recognition could lead to the acceptance and reliance on the approval of medical devices by regulators worldwide. By achieving this recognition, it will promote Malaysia's regulatory efforts, which are aimed at setting a high standard for ensuring the safety and effectiveness of medical devices.

Lastly, my dream and goal are to become a reputable regulator, and I hope this award recognition will help my journey continue to bloom. I do hope I have inspired all the young officers to keep striving and upholding their dreams. As long as you have courage, strength, and confidence in your work, no one can stop you from being successful in your field.

Thank you and Best Regards,

Ms.Aidahwaty M.Olaybal.