Taiwan market access for Medical Devices

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

Taiwan-flagManufacturers wishing to sell their products in Taiwan must comply with registration requirements of the Taiwan Food and Drug Administration (TFDA) 

BSI is a partner in The Technical Cooperation Programme (TCP) on exchange of medical device GMP and ISO 13485 Audit Reports between EU Notified Body Partners and TFDA Authorized Medical Device GMP Auditing Organizations.