Clinical Evaluation of Medical Device to Meet Global Development

Abstract

Timely development of medical devices is placed as one of the main features of the Japan Revitalization Strategy. The old Pharmaceutical Affairs Law was replaced by the new “Act on Securing Quality, Efficacy and Safety of Pharmaceuticals, Medical Devices, Regenerative and Cellular Therapy Products, Gene Therapy Products, and Cosmetics (PMD Act)”, in order to simplify the regulations and facilitate quick access to the medical devices based on their principal characteristics. We evaluate the balance of benefit and risk of a medical device and only when the benefit overweighs the risk, approval can be given. This benefit-risk balance assessment is the fundamental method in regulating drugs and medical devices, as being accepted globally. Many people tend to think that bench tests and/or in-vivo tests are sufficient in evaluating medical devices, as they are only “tools” to cause physical actions. However, medical devices are used clinically, therefore, clinical efficacy and safety should be evaluated based on the clinical data. The regulations on the requirements for premarketing clinical trial data may vary among the countries, however, innovative medical devices need to be evaluated with clinical trial data. The author(s) think(s) that it is very important to discuss among industry, academia and regulators, on how we should optimize the design of the clinical trial to push forward effective development of medical devices.