Approval and Legislation Involved in Development of Medical Devices in Dentistry – A Systematic Review

Abstract

A medical device is defined as “any an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent” and “intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals”. Objective: The objective of this systematic review was to outline the steps and necessary requirements needed for approval and legislation of new medical devices. Methods:  Two databases; PubMed and Google Scholar were electronically searched for articles published from year 2011 to 2021. The following MeSH (Medical Subjects Headings) terms; “new medical devices”, “Regulatory Bodies”, “Approval Medical Devices”, “Pre-market Post-market Approval” along with Boolean operators AND, OR and NOT were used to search for the articles. Results: It is evident from our study that risks associated with new medical and dental devices are being taken seriously by the governments of different countries and intensive work is done to minimize the risks and maximize the benefits of them. Conclusions: It is safe to say that we are entering a new era of safe medical practice along with new and better devices being available for the public. The reforms being made will help not only the hospitals and patients but will also assist the manufacturers in understanding the mechanisms involved in clearing their products for the approval. It will lead to advancement and reshaping healthcare system to combat many challenges faced by it and promote and protect the public health.