Over the years, medical device has undergone significant transformation, with the use of evolving technological tools such as artificial intelligence (AI), machine learning (ML) and Internet of Things. In Malaysia, all medical devices are required to be registered with the Medical Device Authority (MDA), in compliant to the Medical Device Act 2012 (Act 737), before placing in Malaysian market. As for medical device clinical trial, a Medical Device (Exemption) Order 2016 grants exemptions from registration for medical devices designated for clinical investigations or other clearly specified purposes. Through medical device clinical trials, the safety, effectiveness, and performance of the devices could be evaluated before approval for general use and in post-marketing evaluations. While pharmaceutical trials take up the largest share of trials conducted in Malaysia, the potential for medical device clinical trials is an opportunity to be tapped into, particularly with the current robust clinical trial ecosystem in the country. Therefore, this article will be discussing on the current landscape and future outlook of medical device trials in Malaysia.
Regulatory Overview
Medical devices that are intended for clinical investigational use (CIU) or clinical research use (CRU) must follow the process of notification of exemption from Registration of Medical Devices. The review timeline for CIU and CRU is approximately 30 and 14 working days respectively, yet it is important to ensure that all assessment data and required documents are completely compiled according to the guidance document for a successful application. All medical device trials follow the same pathway.
Malaysia’s Medical Device Clinical Trials Landscape
Malaysia’s diverse healthcare landscape presents extensive opportunities for conducting clinical trials across a wide range of therapeutic areas. Based on Figure 1, a total of 46 interventional medical device trials were conducted in the last 6 years. Cardiology/ vascular diseases stands out as the leading area, with 18 medical device trials (Figure 2) contributed by the volume of innovations addressing cardiovascular health which is a critical focus in global healthcare.
These trials were conducted across multiple sites in the public, private and academic centres which are staffed by experienced principal investigators and supportive study team as well as being well-equipped thus ensuring clinical trial are delivered with speed, quality and reliability.
The National Heart Institute has conducted various clinical trials for medical devices, having participated in over 10 trials, including those focused on coronary stents, heart valves, as well as a first in-man trial. Hospitals in the public sector such as Pulau Pinang Hospital, Queen Elizabeth II Hospital and Sultan Idris Shah Hospital have also participated in multiregional clinical trials in which the data generated was used for regulatory submissions.
In this day and age, the incorporation of artificial intelligence (AI) into medical devices has completely transformed the healthcare sector by increasing diagnostic precision especially in early disease detection. As an example, the successful identification of Malaysia’s first lung cancer case was identified using AI which saw the public and private partnership between a local organisation with global pharmaceutical company. This accomplishment highlights how AI medical device will continue to evolve, presenting various opportunities for patients and healthcare professionals in the country to tap into.
