Malaysian Clinical Trial Medical Device Registration Requirements for Prosthetic Heart Valve Constru

Malaysian Clinical Trial Medical Device Registration Requirements For Assessing Performance Of An Implantable Medical Device, Such As a Prosthetic Heart Valve Constructed Of Animal Origin Tissues?

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.

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 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).

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 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).

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.

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).