The biggest challenge that creative medical device Research and Development (R&D) programs face is that of balancing clinical evidence with early patient access. To address this, a new review system was proposed in Japan, to pace up device clearance while maintaining safety and efficacy. This benefits patients who are inflicted with life-threatening diseases that lack effective treatments.

Software as a Medical Device (SaMD) is an emerging category of medical devices that has been experiencing rapid growth in recent years. This category of devices includes medical device software applications designed for medical purposes, such as diagnosis, disease prevention, treatment, and monitoring.

The most significant and crucial step in the device approval process is the labeling aspect. The safe and proper use of medical devices by patients and those who provide care for patients depends on accurate labeling with all the necessary information to ensure market access. Article 63 of the " Act on Securing Quality, Efficacy, and Safety of Products, Including Pharmaceuticals and Medical Devices" specifies medical device labeling regulations for manufacturers who intend to market their products in Japan.

An organized system of protocols and practices known as a medical device quality management system (QMS) addresses all facets of design, production, supplier management, risk management, complaint handling, clinical data, storage, distribution, product labeling, and more. The goal of the QMS is to continuously meet consumer and Regulatory requirements while also improving the quality of medical devices and related services.