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Taiwan FDA contributing towards AHWP's success in international medical device regulatory convergence 【發布日期:2019-12-05】 發布單位:醫療器材及化粧品組

The Food and Drug Administration of Taiwan (TFDA) as a global medical device regulatory leader, has always been an active member of Asian Harmonization Working Party (AHWP) contributing towards the international regulatory harmonization of medical device among the AHWP countries.

The AHWP, an international platform for medical device regulation harmonization for both side of the stakeholders, the regulators and industry, can come together to make out the differences as well as grooming the upcoming regulatory professionals to better serve the sector. AHWP was established in 1999 as a voluntary group of regulators and industry members whose goal is working towards greater harmonization of medical device regulations in Asia, and Taiwan has been an official member since then.

Taiwan was elected as AHWP Vice-chair in 2012 with mission aiming in developing AHWP strategy, and its expansion with international focus. In the same year, Taiwan was also elected as the Chair of In Vitro Diagnostic (IVD) working group (WG2), and continued in office for other two three-years terms until now. WG2 being the most active working group in the AHWP Technical Committee, has been focusing on the harmonization of IVD medical device regulation. In the period of Taiwan chairing the WG2, it has developed fourteen IVD guidance or reference documents and endorsed by the AHWP to support its goal. Furthermore, Taiwan has been active in leading WG2 to collaborate with other AHWP working groups, in addition to collaborating with WHO IVD pre-qualification team to contribute technical comments to WHO Technical Specification and Technical Guidance documents.

With the continuous participation of TFDA and Taiwan in AHWP, sharing the Taiwan experience with the global regulatory professionals, it has shown the Taiwan’s medical device regulatory leadership in Asia and beyond.

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