Pharmaceutical Affairs Act Enforcement Rules Article 13

The categories of medical devices and the qualifications of the related technicians that a manufacturer of medical devices is required to employ, pursuant to Article 32 of the Act, are as follows:1. Manufacturers of general medical equipment, clinical examination equipment, and biological materials and equipment shall employ, as manufacturing supervisor at its factory, a full-time resident technician who is a graduate of the science, engineering, medicine, or agriculture department at the undergraduate or graduate level of a domestic public or accredited private junior college or higher-level educational institution, or of a foreign junior-college or higher level institution recognized by the Ministry of Education.2. Manufacturers of antiseptic contact lens cleaning solutions (or tablets), organ transplant preservation solutions, health materials, or feminine sanitary napkins shall employ a full-time resident pharmacist as manufacturing supervisor at the factory.