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Taiwan FDA's positive contribution to international regulatory harmonization of medical devices

  • Data Source:Food and Drug Administration, Ministry of Health and Welfare
  • Created:2021-08-05
  • Last Updated:2021-08-05

The Food and Drug Administration of Taiwan (TFDA) has been working diligently on facilitating the convergence of medical devices by participating in many global organizations. One of the pivotal contributions to international regulatory harmonization of medical devices is as the Asian Harmonization Working Party/ Global Harmonization Working Party (AHWP/GHWP) WG2 Chair for years. TFDA has achieved outstanding performance on the regulatory harmonization and received positive recognition from the AHWP/GHWP Leaders.

AHWP/GHWP is a voluntary group of regulators and industry members with the goals of developing and recommending approaches for the convergence and harmonization of medical device regulations in Asia and other regions. Taiwan has been an official member since it was established in 1999. TFDA was elected as the Chair of In Vitro Diagnostic (IVD) work group (known as WG2) in 2012, and has continued in office for other terms until now.

Being the most active work group in the AHWP/GHWP Technical Committee, WG2 has been focusing on the promotion of global harmonization in the premarket review processes, and assisting AHWP/GHWP member economies in implementing regulatory framework of IVD medical devices. In the period of Taiwan chairing the WG2, it has already developed fourteen guidance or reference documents and endorsed by the AHWP/GHWP. Furthermore, Taiwan has been active in leading WG2 to collaborate with other AHWP/GHWP work groups and international organizations. Due to the COVID-19 pandemic, WG2 has been assigned as the Joint Working Group (JWG) leader for developing the guidance related to the emergency regulatory mechanisms for medical devices. Furthermore, as WG2 Chair, TFDA routinely joins the International Medical Device Regulators Forum (IMDRF) IVD working group meetings for reviewing and updating the Principles of IVD Medical Devices Classification document. The updated guidance taking into account the current level of development and experience in applying the risk-based approach to the classification of IVD medical devices, has been published on the IMDRF official website on May 21, 2021. In addition, WG2 has established a long-term cooperation relationship with WHO IVD pre-qualification team to contribute technical comments to WHO Technical Specification and Technical Guidance documents.

The continuous and significant participation of TFDA in global medical device regulatory organizations, sharing knowledge and expertise with the global regulatory professionals, have been greatly showing Taiwan’s medical device regulatory leadership and significant role in Asia and beyond.