Medical Devices; Medical equipment (ICS 11.040)

Draft Amendment of Annex I to Article 3 and Article 8 of the "Regulations for Governing the Management of Medical Device" (10 page(s), in English; 7 page(s), in Chinese)

In view of the wide range of scientific fields involved in medical equipment and the complication of medical devices in terms of their varieties, items and components resulted from innovation of technology, the Ministry of Health and Welfare is proposing amendment to Annex I to Article 3 of the "Regulations for Governing the Management of Medical Device" in order to clarify the classification description and intended use situations as well as to harmonize with international regulatory trends. Considering a transition period is necessary for manufacturers to comply with the new requirements, amendment to Article 8 of the Regulation is also proposed.