{"id":3927,"date":"2017-07-11T10:44:53","date_gmt":"2017-07-11T08:44:53","guid":{"rendered":"http:\/\/www.thema-med.com\/?page_id=3927\/"},"modified":"2023-10-06T10:20:55","modified_gmt":"2023-10-06T08:20:55","slug":"medical-device-registration-taiwan","status":"publish","type":"page","link":"https:\/\/www.thema-med.com\/en\/medical-device-registration-taiwan\/","title":{"rendered":"Medical Device Registration in Taiwan"},"content":{"rendered":"
\"taiwan\"<\/span><\/div>
Regulatory Authority<\/b><\/h5>\n

Taiwan Food and Drug Administration (TFDA).<\/p>\n

Classification<\/strong><\/h5>\n

I, II, III<\/p>\n

Quality system<\/b><\/h5>\n

ISO 13485:2016<\/p>\n

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<\/i><\/span>The information on this page is valid and current as of June 2018. The legislative and regulatory provisions are subject to changes and updates by the Regulatory Authorities of the State to which they refer. Considering the above, the writer declines all responsibility regarding any non-actuality and\/or inaccuracy of the information received concurrently with or following the publication of this page Disclaimer<\/a><\/strong><\/em><\/span><\/div><\/div><\/div><\/div>

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.<\/p>\n

\u27a2 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.<\/p>\n

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.<\/p>\n

\u27a2 Device registration stage:
The device registration \/ approval procedure varies according to the risk class of the device to be imported:<\/p>\n

\u2022 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).<\/p>\n

\u2022 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).<\/p>\n

\u2022 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.<\/p>\n

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Applicant<\/span><\/h3>\n

The foreign manufacturer shall appoint a Taiwan Agent, or a Local Representative\/distributor acting as an Applicant.<\/p>\n

Timeframe and fees<\/span><\/h3>\n

Class I: 1-2 months
Class II: 10-12 months
Class III: 10-12 months<\/p>\n

The renewal application shall be submitted 10 months before the expiry date.<\/p>\n

Validity<\/span><\/h3>\n

Licence: 5 years<\/p>\n

Labelling and documentation language<\/span><\/h3>\n

Documentation and labelling must be provided in traditional Chinese or English.<\/p>\n

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    Do you want to market your Medical Device in this Country? Contact us!\n<\/h3>\n