Taiwan market access

Taiwan Food and Drug Administration of the Department of Health (TFDA) and ISO 13485

Taiwan market accessManufacturers wishing to sell their products in Taiwan must comply with registration requirements of the Taiwan Food and Drug Administration of the Department of Health (TFDA), Republic of China (R.O.C). Pre-market approval is necessary for all classes of medical devices prior to Taiwanese market entry.

Foreign manufacturers must demonstrate their compliance with Good Manufacturing Practise (GMP) requirements by submitting Quality System Documentation (QSD) prior to registration for many devices.