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Brochure: The IAF Initiative for Accredited Certification to ISO 13485 - Medical Devices
Relationship to guidance from the Global Harmonization Task Force (GHTF)
The IAF ISO 13485 medical devices initiative has been optimized using GHTF guidance. For many years, GHTF members have strived to create a system of documents that can form the basis for medical device regulatory programs worldwide.
The IAF initiative utilizes GHTF guidance from Study Group 4 concerning regulatory auditing practices. The initiative incorporates this guidance to support an infrastructure that links regulatory authorities, accreditation bodies, certification bodies, and medical device manufacturers.
The IAF initiative for ISO 13485 does not require use of any additional GHTF documents. IAF accredited certification does however support regulations that incorporate other GHTF guidance. If GHTF guidance is to be used in forming a new medical device regulation, the following uses of GHTF guidance should be considered.
Guidance documents from GHTF Study Groups 1, 2, 3, and 5 describe core concepts for developing a harmonized medical device regulatory system. Regulators may reference such documents for use as criteria that manufacturers must follow or they may adopt the language directly into national law. GHTF Study Group 4's guidance relevant to IAF ISO 13485 accredited certification has already been included in the IAF Mandatory Document for the application of ISO/IEC 17021 (IAF MD9).
Regulatory bodies may not want or be able to fully implement all documents and requirements of the GHTF due to particular local or national concerns. Therefore regulators should make the medical device industry aware of any national deviations from the GHTF approach that could possibly cause manufacturers delays in compliance. It is also very important to consider the restrictions on legal access to medical devices that may result from imposing deviations.
Note: Whilst the long-term future of the GHTF is not certain, as at 2011 the view of achieving harmonised regulatory requirements remains a highly desirable objective, particularly in view of the pressures of a globalised manufacturing market for medical devices and increasing demands to streamline regulatory processes in order to deliver high quality products to the marketplace with minimal delays. The GHTF regulator’s group considered that the best way to achieve such an outcome was to develop a regulator-led harmonisation and collaboration group that would allow for more detailed discussion between members on the optimum ways to achieve harmonisation at an operational level. The strategy of achieving this, together with adequate input and advice from industry, was still under consideration in mid-2011.