Is the GHTF still active?
The GHTF disbanded late in 2012. Its mission has been taken over by the International Medical Device Regulators Forum (IMDRF), a successor organization composed of officials from regulatory agencies— not industry — around the world. The GHTF website is no longer operational.
What are GHTF guidelines?
The purpose of the GHTF is to encourage a convergence in standards and regulatory practices related to the safety, performance, and quality of medical devices. The GHTF also promotes technological innovation and facilitates international trade.
Who is Imdrf?
IMDRF is a voluntary group of medical device regulators from around the world who have come together to build on the strong foundational work of the Global Harmonization Task Force on Medical Devices (GHTF) and aims to accelerate international medical device regulatory harmonization and convergence.
Which ISO standard was made specifically for medical devices?
ISO 13485:2016
ISO 13485:2016 is based on the ISO 9001 process model approach and is a management systems standard specifically developed for the manufacture of medical devices.
What is sted medical device?
Summary Technical Documentation (STED) was developed to drive more standardization of medical device regulatory submissions across markets. STED is recognized by US, European, Canadian, Australian and Japanese regulators, as well as in other markets.
Does EU recognize Mdsap?
Europe (EU) has only been participating in the MDSAP pilot as an observer, as there are concerns that it would be difficult to obtain agreement among all member states.
Who certifies medical equipment in India?
The Quality Council of India (QCI)
The Quality Council of India (QCI), and the Association of Indian Manufacturers of Medical Devices (AiMeD) have added further features to the ICMED the Scheme that had been launched for Certification of Medical Devices in 2016.
Who are the members of the GHTF?
The members of the GHTF include government and industry officials from the European Union, Japan, Canada, Australia, and the United States.
What is the GHTF?
The GHTF, a voluntary group founded in 1992 by and representing the regulating medical device authorities of Australia, Canada, EU, Japan, and the United States, pursued a harmonization on global base (Figure 2. 5).
How is who involved in the European Union’s GHTF?
The medical devices team at WHO welcomed the chairmanship of the European Union of the GHTF in 2004 and the opportunity to identify areas and mechanisms for increased collaboration, including an observer role on the Steering Committee and Vigilance Study Group.
How many study groups are there in the GHTF?
The GHTF had four study groups [ 19 ], and the scope of each group is shown in Figure 10.1. Figure 10.1. Scope of the four GHTF study groups.