Taiwan working to upgrade medtech regulations

04/21/2013 | BioSpectrum Asia

Taiwan, the fifth-largest medtech market in Asia, is working to ensure that its regulations better harmonize with international standards. The Taiwan FDA announced late last year that it would start applying the Summary Technical Documentation format used by the EU, United States, Canada, Japan and Australia, and is on track to have this fully executed for Class II and III medical devices by July. The TFDA has allowed online sales of low-risk medical devices without the need for physical inspection. Taiwan's requirements for identifying "Country of Origin," however, remain a problem.

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