Clinical Research Malaysia -

Running head: MALAYSIAN CLINICAL TRIAL
MALAYSIAN CLINICAL TRIAL
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MALAYSIAN CLINICAL TRIAL1
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