GHTF ceases to work

Recommendation

23-25 April 2024

Cleaning Validation AND Pre-Course Workshop: Impact of Annex 1 Revision on Cleaning Validation - Live Online Training

The Globalisation Harmonisation Task Force (GHTF) ceased to work by the end of 2012. Founded in 1992 it was sort of "ICH for medical devices", i. e. a harmonisation organisation for regulations that are important for the medical devices industry. It was comprised of members from authorities as well as from industry and of the Triad EU, USA and Japan. But Canada and Australia have also taken part. The GHTF has published many helpful guidelines on the following topics:

• Pre-market evaluation 
• Vigilance 
• Quality systems 
• Auditing  
• Clinical safety

The guidelines have been very topical and often showed the way that was later also followed by comparable guidelines in the sector of medicinal products (for instance concerning the topic process validation). In this respect, the GHTF guidelines have attracted interest also outside the sector for medical devices. 

What happens now with these guidelines after the GHTF has ceased to work?

The GHTF has been replaced by the International Medical Devices Regulator Forum (IMDRF) that will partly carry on with GHTF's tasks. As the name implies, the medical devices industry (unfortunately) is no longer represented in this organisation. This means that the harmonisation efforts are now carried out only by the participating regulatory authorities. Current members are the corresponding medical device regulatory authorities of Australia, Brazil, Canada, the European Union, Japan and the United States. China and Russia will also become members in the near future. The World Health Organization (WHO) has an observer status.

The IMDRF has defined five priorities of its work.

• Review of the National Competent Authority Report (NCAR) System 
• Roadmap for the implementation of a Unique Devices Identification (UDI) System 
• A Medical Device Single Audit Programme (MDSAP) 
• A common list of recognised standards 
• A standardised submission process for regulated products (RPS)

Fortunately, the IMDRF has taken over the "old" GHTF-Guidelines and plans to develop them further if necessary. Requests for changes are to be submitted to the IMDRF-Secretariat.  

Conclusions: GHTF is dead, long live the IMDRF. Something like this could be the message. Another aim to be reached with the setting up of the IMDRF is to accelerate changes for harmonisation. This is an optimistic aim. Fortunately, the IMDRF still makes available the "old" GHTF-Guidelines on its Website and even plans to develop them further if necessary. It remains to be seen how the IMDRF will design GHTF's succession.

You can find the IMDRF-Website using the Link options on the ECA website.