JOHOR BAHRU, Dec. 11 – Universiti Teknologi Malaysia (UTM) recently organised a workshop titled “Notification Requirements for Clinical Research on Medical Devices Based on the Medical Device (Exemption) Order 2024”, aimed at strengthening researchers’ understanding of regulatory compliance in medical device research. The workshop successfully gathered 35 researchers and academic staff from UTM, Universiti Tun Hussein Onn Malaysia (UTHM), Newcastle University Medicine Malaysia (NUMed), and Sunway College, reflecting strong interest from both public and private higher education institutions.
The programme was organised by UTM’s Institute of Human Centered Engineering (iHumEn) as part of its continuous efforts to support translational research and responsible innovation. The workshop was led by Assoc. Prof. Dr Syafiqah Saidin emphasised the importance of aligning academic research with national regulatory expectations. She highlighted that understanding regulatory pathways is essential for ensuring that innovative medical device research can progress beyond the laboratory stage towards clinical application and eventual commercialisation.
The workshop featured expert speakers from the Medical Device Authority (MDA), namely Aidahwaty Ariffin @ M. Olaybal, Director of the Pre-Market Division, along with Assistant Directors Nur Syafura Ariffin and Che Rosmani Che Hasan. Their sessions provided comprehensive insights into Malaysia’s medical device regulatory framework, including exemption criteria under the Medical Device (Exemption) Order 2024, device classification, and the overall medical device lifecycle from early-stage prototyping to clinical evaluation and regulatory approval.
A key focus of the workshop was the regulatory principles underpinning medical device evaluation, particularly the three core pillars of safety, performance, and efficacy. Participants were also introduced to Good Clinical Practice (GCP) requirements for medical devices in accordance with ISO 14155:2020, which outlines ethical and scientific standards for conducting clinical investigations involving human subjects.
One of the highlights of the programme was an interactive, hands-on session that guided participants step-by-step through the preparation and submission of clinical research notifications using the MDA online portal. This practical exercise allowed researchers to better understand documentation requirements, common errors, and strategies to ensure smoother submissions.
Assoc. Prof. Ir. Dr Nadia Adrus, one of the participants, described the workshop as highly beneficial. She noted that the practical submission session significantly improved her confidence in managing regulatory documentation and navigating compliance requirements for clinical research involving medical devices.
Overall, the workshop was well-received for its expert-led content, practical orientation, and direct relevance to researchers involved in medical device development. The successful organisation of this event underscores UTM’s commitment to promoting safe, compliant, and high-quality medical technology research, while fostering closer collaboration between academia and national regulatory authorities.
