Taiwan market access for Medical Devices

Taiwan Food and Drug Administration (TFDA), Technical Cooperation Programme (TCP) 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 (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 Autorized Medical Ddivce GMP Auditing Organizations.