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Vision, Mission and Goal

Vision

To achieve international harmonization of medical device regulatory framework among regulatory authorities, convergence of regulatory requirements, open and trust-based efforts between regulatory authorities and the industry across the globe.

Mission

To strategically accelerate medical device regulatory convergence through promoting an agile and fit-for purpose regulatory model for medical devices based on latest development in regulatory science. To lead and promote systematic capacity building for future-ready regulatory professionals in light of emerging technologies while enabling patient safety and timely access to safe and effective medical devices.

Goals

  • To develop and recommend approaches for the global convergence and harmonization of medical device regulations.
  • To facilitate the exchange of knowledge and expertise amongst regulators and the industry for the establishment of harmonized requirements.
  • To promote capacity building in members and to foster strategic membership expansion.
  • To work in collaboration with related international organizations such as International Medical Device Regulators Forum(IMDRF), WHO, ISO, IEC.