• The MDA has enhanced regulatory efficiency through MEDCAST 3.0, a fully digital system that incorporates artificial intelligence, auto-renewals, and chatbot support.

• It has intensified enforcement efforts by introducing import permits and legal actions to prevent the circulation of substandard and unregistered medical devices.

• Through its 2024-2028 Strategic Plan, the MDA is adopting global standards and initiatives, such as UDI and e-labelling, to position Malaysia as a regional leader in medical device regulation.

BY FARISHA RAHMAN

MDA is a statutory body under the Ministry of Health( MoH). Dr Muralitharan Paramasua is the chief executive.

In an exclusive interview with The Health, Dr Muralitharan shared insights into the MDA’ s key initiatives, its challenges, and the strategic vision that will shape the future of healthcare regulation in the country.

LAW ENFORCEMENT

The MDA, established under the Medical Device Act 2012, regulates the entire life cycle of medical devices. This includes oversight of manufacturing, importation, distribution and use in the healthcare sector.

Dr Muralitharan explained that the first step was to introduce the Medical Device Act, which provided the legal foundation for regulating both the devices and the establishments that produce or distribute them.

“ The first initiative we introduced was enacting the law, Act 737, to regulate these medical devices. It is to ensure the safety and performance of medical devices that meet criteria or standards set internationally and professionally,” he said.

This regulation has brought structure to a previously fragmented sector, ensuring that only certified, high-performing medical devices reach healthcare providers and patients.

MEDCAST EVOLUTION

Digital transformation has become a cornerstone of MDA’ s strategy. A significant milestone was the introduction of the Medical Device Centralised Application System( MEDCAST), which replaced manual processes with a digital platform for registration and approvals.

“ This MEDCAST has revolutionised the whole application system. Applications are now online, and approvals are also

done digitally. Once approved, certificates are issued in digital format,” explained Dr Muralitharan.

Currently, the agency is rolling out MEDCAST 3.0, an enhanced version that incorporates artificial intelligence to assist with initial assessments of applications.

New features, including auto-renewals, a change management system, and a chatbot, have been introduced to streamline communication and improve turnaround times.

These digital innovations reflect the MDA’ s commitment to modernising regulatory processes and enhancing its service to the medical device industry.

STRENGTHENING ENFORCEMENT

While digitalisation has improved efficiency, ensuring compliance remains a core responsibility of the MDA. Its enforcement and vigilance teams conduct regular inspections at pharmacies and health institutions, monitor online platforms and investigate public complaints.

Dr Muralitharan noted that the agency takes violations seriously, stating:“ We are taking serious actions against those who commit this crime under Act 737. If they are found guilty, we either suspend their licences, revoke them, or bring them to court.”

Substandard medical devices, particularly those sold online, have become a growing concern. Recent investigations revealed that several products available on e-commerce platforms failed to meet safety and performance standards. Some of these products included oxygen concentrators, thermometers and blood glucose monitors.

“ Some of the devices showed inaccurate or confusing readings and results, leading to serious health risks,” he said.

To address this, the MDA introduced an import permit system in collaboration with customs authorities. This allows the agency to monitor and control the entry of medical devices into Malaysia, ensuring that only approved and safe products reach consumers.

RAPID ADVANCEMENT

The rapid evolution of medical technology presents an ongoing challenge for regulators. MDA must continuously adapt its frameworks to keep pace with innovation while maintaining safety standards.

Dr Muralitharan acknowledges that this is one of the most significant hurdles the agency faces.

“ The concept of‘ one size fits all’ doesn’ t work anymore. By the time we approve version 1 of a software-based device, version 5 may already be out,” he said.

To address these challenges, the MDA is introducing more flexible regulatory mechanisms, such as the Predetermined Control Change Process( PCCP). This approach enables quicker updates and approvals of revised technologies while ensuring that all safety protocols are upheld.

The agency is also focused on building internal expertise, ensuring its evaluators are equipped to understand and assess the latest innovations in medical technology.

CONSUMER AWARENESS

Public education plays a critical role in ensuring medical devices are used safely