Regulatory Authority
Taiwan Food and Drug Administration (TFDA).
Classification
I, II, III
Quality system
ISO 13485:2016
Pre-market approval is required for all classes of Medical Devices, and consists of two stages: the Quality System approval stage and the device registration stage.
➢ Quality System approval stage:
Foreign manufacturers shall demonstrate their compliance with Good Manufacturing Practice (GMP) requirements; in particular, compliance with ISO 13485:2016 shall be demonstrated.
Sterile Class I, measuring Class I, Class II and III devices must meet the GMP requirements before obtaining the TFDA license; Class I non-sterile devices are exempted. Following the approval of the Quality System, the TFDA issues a Certificate of Quality System Registration (QSD) valid for 3 years and it shall be attached to the device registration/approval application.
➢ Device registration stage:
The device registration / approval procedure varies according to the risk class of the device to be imported:
• As regards Class I devices, it is sufficient to submit the registration application and the documentation for the Quality System (the latter is not to be submitted in case of non-sterile Class I devices).
• As regards Class II and III Medical Devices and new Medical Devices, in addition to the registration application and the documentation for the Quality System it is necessary to prepare the documentation in STED format (Standard Technical Documentation), including information on the device, products testing and clinical analysis data (if practicable).
• Following the approval, the TFDA issues the device license (Medical Device Permit License) valid for 5 years on behalf of the manufacturer, and the renewal application must be submitted 10 months before the expiry date.
Applicant
The foreign manufacturer shall appoint a Taiwan Agent, or a Local Representative/distributor acting as an Applicant.
Timeframe and fees
Class I: 1-2 months
Class II: 10-12 months
Class III: 10-12 months
The renewal application shall be submitted 10 months before the expiry date.
Validity
Licence: 5 years
Labelling and documentation language
Documentation and labelling must be provided in traditional Chinese or English.
