ABSTRACT

With Increased use of medical devices, strict regulatory standards are required to ensure that devices are safe, well-studied and have the least adverse reactions. The updated TGA guidelines and the legislative amendment provide adequate guidance for both manufacturers and the competent authorities to manage cases effectively and in an appropriate manner. These guidelines shall be updated annually according to the schedule, which provides a high level of encouragement in the research of medical devices, as is currently the case. Pharmacy staff can certainly play an important role in the regulation of medical devices. The safety, risks, effectiveness and performance of medical devices must be well established and properly regulated. It is hoped that the guidelines will be implemented and properly regulated with an effective outcome. Keywords: Medical devices, Adverse reactions, TGA Guidelines, Manufacturers
Publication date: 01/12/2021

https://ijbpas.com/pdf/2021/December/MS_IJBPAS_2021_5779.pdf

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https://doi.org/10.31032/IJBPAS/2021/10.12.5779