2020 Volume 33 Issue 4 Pages 313-323
The Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (“PMD Act”) requires that medical devices to be used in dental practice be approved for manufacture and sales or otherwise certified. Dental practitioners are therefore obligated to use approved or certified medical devices. There are, however, many uncertainties concerning the pre-marketing approval/certification process, and the characteristics and features of dental medical devices examined during that process have not been made clear. These uncertainties seem especially evident in medical device programs or other similar programs that are now subject to the same rules and regulations of the PMD Act as conventional medical devices, and are likely to trouble not only companies in the dental field but also those aspiring to enter the field from other industries.
For medical devices to be approved, they must undergo an approval review process by the Pharmaceuticals and Medical Devices Agency (PMDA). During the review process, the efficacy, effectiveness, and other clinical benefits of the medical device in the treatment and diagnosis of patients are examined, along with its clinical safety, which is essential to justify their use in clinical settings. Understanding not only the regulations of the PMD Act governing medical devices but also the approval review process can be useful in deepening our understanding of the intended use and effectiveness of medical devices in daily clinical practice or other similar settings.
This article mainly describes the following : (i) the meaning of medical devices as defined by the PMD Act ; (ii) the classification of medical devices that takes into consideration their risks to safety ; (iii) an overview of the approval review or other similar process for medical devices ; (iv) a regulatory framework for quality and safety assurance ; and (v) how medical devices in the field of dental and oral care are reviewed and the association with other regulations concerning dental practice. It also presents prospects for the future of regulations governing medical devices, which have important implications for devices used in the field of dental and oral care.
