Medical Device Clinical Trial Regulations in Malaysia: A Report

This report analyzes the key regulations for conducting clinical trials in Malaysia, specifically focusing on medical devices like prosthetic heart valves made from animal tissues. It details the necessary approvals from bodies such as the Medical Device Authority (MDA), Drug Control Authority (DCA), and the Ministry of Health (MOH), including the classification of medical devices, required certifications (CE mark, ISO), and the role of Malaysian Authorized Representatives (MAR). The report outlines the application processes, including the use of the ASEAN Common Submission Dossier Template (CSDT) and the need for Clinical Trial Import Licenses (CTIL) and exemptions (CTX). It emphasizes reporting requirements for participant data, adverse events, and trial results to the MDA and ethics review committees. Additionally, it clarifies the responsibilities of sponsors, including financial compensation for participants in case of harm. The report concludes by highlighting the importance of ethical conduct and adherence to regulations for successful clinical trials in Malaysia.

Running head: MALAYSIAN CLINICAL TRIAL
MALAYSIAN CLINICAL TRIAL
Name of the Student:
Name of the University:
Author note:

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Introduction
The key regulations pertaining to the implementation of clinical trials comprising of
examining the effectiveness of medical devices in Malaysia, have been developed by the Medical
Device Authority (MDA, 2020). The following paper will briefly discuss on essential clinical
trial and medical equipment regulations to be considered with respect to the implantation of
medical devises of the prosthetic type composed of animal tissues.
Discussion
Necessary Approvals
For gaining permission to use a prosthetic valve composed of animal tissues in clinical
trials, approvals which will be required are: a classification record of the prosthetic valve
composed of animal tissues, an approved confirmatory assessment, a CE mark of certification, an
ISO certificate for labelling as well as the Malaysian Declaration of Conformity, a certificate of
quality management system and a completed checklist of the Malaysian Essential Principles
(Yusof 2016). In order to acquire necessary approvals for usage of prosthetic medical device in
clinical trials, the concerned researcher may be required to contact relevant personnel such as an
authorized Malaysian Representative as well as a Conformity Assessment Body (CAB) with
significant accreditation (MDA, 2020).
As a part of the first process of a prosthetic valve composed of animal tissues and clinical
trial application, the researcher has to classify the notable medical device as per Appendix 1 of
the MDA’s Medical Device Regulations 2012, which is likely to be Class C since the prosthetic
medical device is likely to impose high levels of individual but moderate levels of risk for public
health (Ministry of Health, 2020). In cases where the researcher is non-Malaysian, there is a need

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to contact a Malaysian Authorized Representative (MAR) who will mediate between the
researcher and the MDA for acquiring approval with respect to registration of the medical
device. Since this device is a Class B, the researcher will be required to contact the CAB and
prepare a device documentation as well as the above documents via an ASEAN Common
Submission Dossier Template (CSDT). After verification of these documents by CAM, the
researcher will hand over the same to the MAR for submission to the MDA. In the absence of
any limitations, the MDA grants approval, a registration number and certificate to the prosthetic
valve composed of animal tissues for renewal after every 5 years (MDA, 2020). Additional
bodies from which the research has to acquire approval include the: Drug Control Authority
(DCA), National Pharmaceutical Regulatory Agency (NPRA), Medical Research & Ethics
Committee (MREC), National Pharmaceutical Control Bureau (NPCB) and Ministry of Health
(MOH) (Wong and Tong 2018). To further ensure that approval for the clinical trial involve
prosthetic valve with animal tissue, the researcher as a part of the regulatory process has to
acquire a Clinical Trial Import License (CTIL) and a Clinical Trial Exemption (CTX). These will
ensure that the researcher can import any products as well as engage in the manufacturing of
products for the production of samples required in the clinical trial comprising of prosthetic
valve. Lastly, the clinical trial using prosthetic valves can only be conducted if it is approved by
the Ministry of Health Medical Research and Ethics Committee (MOHMREC). This has to be
via online submission of the clinical trial and medical device application using the National
Medical Research Register (Ministry of Health, 2020).
Reporting Requirements
Prior to as well as during the trial using prosthetic valve composed of animal tissues, the
researcher must report relevant participant data based documents due to the MDA based on

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informed consent obtained from participants, adherence to ethics as per Declaration of Helsinki
and approval from an independence ethics committee. In case of any adverse events, legal
professionals of all participants must be informed of research details and risks with sufficient
time hand (Wong and Tong 2018). The researcher will also have to inform the review committee
on the risks and compensations prevalent in the research.
After trial completion comprising of usage of prosthetic valve composed of animal
tissues, the researcher must communicate the results to the MDA, the ethics review community
as well as legal professionals of participants (MDA, 2020).
Responsibilities of Sponsors
It is the responsibility of the sponsor to procure information from the researcher on
researcher’s address, names as well as participant consent and review approval forms.
Additionally, in case of any harms incurred in participant due to the research, it is the
responsibility of the sponsor to financial compensate any medical treatments for the participants
(Wah 2018).
Conclusion
This paper thus provides a brief yet detailed insight into the relevant approvals and
processes to be acquired with respect to medical device based clinical trials in Malaysia. To
conclude, researchers and sponsors must responsibly compensate participants in case of adverse
events.

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References
MDA, 2020. Registration of Medical Devices. [online] mda.gov.my Available at:
https://portal.mda.gov.my/documents/seminar-on-implementation-of-act-737/84-registration-of-
medical-device-the-requirements-idamazura/file.html [Accessed 14 Mar. 2020].
Ministry of Health, 2020. Medical Device Guidance Document. [online] mda.gov.my Available
at: http://www.mdb.gov.my/mdb/documents/gd/gd_classification_draft1.pdf [Accessed 16 Mar.
2020].
Wah, Y.S., 2018. Malaysia: Medical Device Regulatory System. In Handbook of Medical
Device Regulatory Affairs in Asia (pp. 513-521). Pan Stanford.
Wong, J. and Tong, R. eds., 2018. Handbook of Medical Device Regulatory Affairs in Asia. CRC
Press.
Yusof, N., 2016. Challenges for tissue banking in the Asia-Pacific region and recent progress in
Malaysia. In Legal Basis of Global Tissue Banking: A Proactive Clinical Perspective (pp. 121-
147).