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Taiwan (ROC Taiwan)

Companies wishing to sell medical devices in ROC Taiwan need to comply with the Taiwan medical device regulations.

SGS is one of the few bodies operating under the ROC Taiwan Technical Co-operation Program (TCP) allowing us to certify quality systems for the Taiwanese market. Our expertise can assist you in achieving certification in the simplest, most cost-effective manner. Under Taiwanese regulations, your Taiwan Authorized Distributor must obtain the medical device license. However, as the exporting manufacturer you will need to provide the distributor and Department of Health with extensive quality documentation unless you take advantage of our TCP Program.

With SGS as your certification partner, we can combine assessments and certification standards to reduce submissions and the time taken for approval. All manufacturers looking to enter the Taiwanese market will benefit from an SGS CE mark certificate and an SGS UKAS accredited ISO 13485:2003 certificate.

If you are situated in Europe we can endorse your ISO 13485 report with a special Taiwan TCP document confirming compliance with the Taiwan medical device regulations. This means you do not need to submit any further quality documentation.

If you are situated in the USA, or elsewhere, we can issue a letter detailing your certified product range which will reduce further paperwork.

Support your organization’s entry to the ROC Taiwan’s medical devices market through compliance with the Taiwan medical device regulations, with certification from SGS.

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