Rules are necessary in medical care, not only for medical professions, as defined by the Medical Practitioners Act, etc. (see Chaps. 3 and 4 ), and hospitals and clinics, as defined by the Medical Care Act (see Chap. 5 ), but also for pharmacies, drugstores, and the efficacy and safety of drugs and medical devices [1, 2]. The Pharmaceutical Affairs Act, enacted in 1960, has established regulations to ensure the quality, effectiveness, and safety of pharmaceuticals, quasi-pharmaceuticals, cosmetics, and medical devices. Major amendments were made to the Act on Securing Quality, Efficacy, and Safety of Products, Including Pharmaceuticals and Medical Devices Act (PMD Act) in 2013 [3]. This amendment established independent chapters for medical devices, distinct from those for pharmaceuticals. It also covers the manufacture and sale of regenerative medical products which are related to gene or cell therapy for disease treatment or prevention under the same act [3].