Medical Devices Act Article 14

Those applying for being registered as a medical device manufacturer may also engage in such business as wholesale, retail, export, rental, or repair of its self-manufactured medical devices that have been listed or approved, or import of raw materials for their own use, without applying for a medical device dealer permit.Pharmacies may concurrently engage in the retail business of medical devices of the classes announced by the central competent authority. Those who concurrently engage in the retail business of medical devices are applicable to the provisions governing the medical device dealers set forth in this Act, but may be exempted from applying for a medical device dealer permit.Medical institutions for the necessity of conducting business may supply medical devices related to the business and may be exempted from applying for a medical device dealer permit. However, those who supply medical devices for patient use not as conducting business but for the sale or retail thereof shall nevertheless file an application for medical device firm registration in accordance with the provisions of Paragraph 2 of Article 13.