End of GHTF (Global Harmonisation Task Force)

Elsmar Forum Sponsor

Statistical Steven

Statistician
Staff member
Super Moderator
#6
From Eucomed:

Eucomed have been made aware of developments within GHTF regulators at closed door regulators only meeting in Washington 17-19 Feb which point to a fundamental shift in future thinking by regulators on how global collaboration and harmonisation should function. Eucomed together with AdvaMed, MEDEC, MTAA and JFMDA have been in communication this week ahead of what was a hastily pulled-together coordinated simultaneous communication by Regulators to GHTF Associations this Friday (this morning).

The main points are:

• There is a concern particularly within the FDA on the negative image to outsiders of a joint regulator/industry collaboration and decision model
• The regulators feel that GHTF has reached a stalemate because of poor implementation of the model
• The GHTF is not inclusive and has been viewed as an exclusive organization.
• The regulators want a broader engagement with other stakeholders such as consumers and healthcare professionals; they also want to meet separately and then engage with those other stakeholders
• A new regulator-only forum will have wider reach beyond founding member countries into the emerging regulatory agencies
• For example, WHO and BRIC countries will also be in the Steering Committee in the Steering Committee.
• There will be more broadly-based technical working groups to look at technical issues which will report in to the regulator forum (comprising the extended interest groups of industry, HCPs, consumers)
• The Brisbane meeting will go ahead and be used to determine what work remains to be completed and the process for an orderly wind down of GHTF. No new work will be commenced.
• The regulators will form its own organization (no industry reps) and will decide what work items will be pursued. Some work items will be among themselves, others will involve other stakeholders including industry, academia, patient and consumer groups.
• This new organization will have closed meetings with an open session at which others (industry, academia, patient and consumer groups) may be invited to participate.
• The new regulators organization will also invite regulators from other jurisdictions to become members.
• There will be a transition process which will be discussed at the March teleconference and May meeting. We will be receiving a formal letter describing the decision.
• The "International Cooperation on Cosmetic Regulation" (ICCR: EU, US, CA, JP) model as to how the system might work

1st day: 2 parallel meetings: Regulators Only Steering Committee and Industry Group
2nd day: Joint meeting, Industry presents issues, discussed by all, draft conclusions drawn
3rd day am: 2 parallel meetings to ‘digest’ joint meeting: Regulators Only Steering Committee and Industry Group
3rd day pm: Open session with NGO’s, Consumer groups, other regulators etc.
4th day am: Regulators only finalise conclusions
 

bio_subbu

Super Moderator
#7
Got a brief statement in "Pulseline". Please refer below...

"A recent meeting of the regulators from the founding member countries of GHTF (US, EU, Japan, Canada and Australia) resolved to terminate the GHTF, which for the past 18 or so years has worked on the development of a regulatory model and supporting documents to underpin globally harmonised regulation of medical technologies. The decision has been communicated to the industry associations in the founding member countries, which to date have participated on an equal footing with regulators. The regulators have proposed a new regulator-only forum with global reach, which will consult with other interested groups including industry, healthcare professionals and consumers in the advancement of regulatory harmonisation.

The national and regional industry associations involved in GHTF will be meeting shortly to map out their response.

The next (and possibly final) meeting of the GHTF will be held in Brisbane in May".
 

Ajit Basrur

Staff member
Admin
#9
As per Mass Device,

The Global Harmonization Task Force, a group of regulatory bodies from around the world, vote to dissolve and reconstitute without any industry trade group members.

An international group of medical device regulators, the Global Harmonization Task Force, is giving the boot to industry representatives.

The founding regulatory bodies of the group, formed to hammer out global standards for medical devices, decided to terminate the organization and start over — without trade groups as members.

The U.S. Food & Drug Administration and the regulatory agencies of the European Union, Japan, Canada and Australia make up the GHTF. The group was founded in 1992 in “an effort to respond to the growing need for international harmonization in the regulation of medical devices," according to its website.

"[F]or the past 18 or so years [the GHTF] has worked on the development of a regulatory model and supporting documents to underpin globally harmonized regulation of medical technologies," Medical Technology Assn. of Australia CEO Anne Trimmer wrote on her organization's website. The MTAA represents the medical device industry Down Under.

To date, she wrote, "industry associations have participated on an equal footing with regulators," adding that the new organization will consult with interested groups, including industry, healthcare providers and patients.

The soon-to-be-former trade association GHTF members plan to compose a response to the regulators' action at their next meeting in Brisbane, Australia, in May, according to Trimmer.
 
Thread starter Similar threads Forum Replies Date
F Procedure for Device End of Life/Obsolescence Other Medical Device and Orthopedic Related Topics 3
B ISO 11607-1 for surgical instruments sterilized by end user Other Medical Device Related Standards 1
L External power supplies: How close does the safety report have to match the end-use application? IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
M Informational From Medtech Insight – QSR/ISO 13485 Harmonization Update: FDA Enforcement Discretion Likely When New Rule Stands Up; Draft Reg Coming By Year’s End; Medical Device and FDA Regulations and Standards News 0
M End of Life or Device transfer regulations for Legal Manufacturer Other Medical Device Regulations World-Wide 1
Ronen E Informational ISO 13485:2016 Transition Period End - 1 March 2019 ISO 13485:2016 - Medical Device Quality Management Systems 0
M FDA News USFDA Proposes to End Temporary Extension of GUDID’s Grace Period Medical Device and FDA Regulations and Standards News 3
supadrai My short yet eventful stint as a regulatory affairs lawyer dude is coming to an end! Career and Occupation Discussions 1
L Cytotoxicity at the end of life-time Other Medical Device Related Standards 3
M Where does our regulatory responsibility end? ISO 13485:2016 - Medical Device Quality Management Systems 11
J Medical Device End of Life and Complaints 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
T New to WEEE Directive - Selling a medical device directly to a professional end-user RoHS, REACH, ELV, IMDS and Restricted Substances 1
P Sample of an end-use-letter for drugs according to FDA requirements US Food and Drug Administration (FDA) 2
M Forced NOT to meet End Customer Expectations - Corrupt Third World Country ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
J Who is the Customer - Who is the End User Manufacturing and Related Processes 2
Colin I am retiring at the end of this month - March 2017 Coffee Break and Water Cooler Discussions 19
E Manufacturer's responsibility to notify the NB regarding Medical Device End-of-Life CE Marking (Conformité Européene) / CB Scheme 1
Marc Stem Cell stimulation to end tooth Root Canals World News 0
C Calibration Dates - Exact day or end of month? General Measurement Device and Calibration Topics 24
A End of Life for Medical Mobile App (Stand Alone Software) Medical Information Technology, Medical Software and Health Informatics 5
somashekar Info about a specific federal regulation - End use and end user information Misc. Quality Assurance and Business Systems Related Topics 2
A How to handle complaints after end of specified medical device life-time ISO 13485:2016 - Medical Device Quality Management Systems 5
J How to document discontinuation or end of life for a software version ? IEC 62304 - Medical Device Software Life Cycle Processes 3
A Medical Device Distribution in the EU to Patients (End-Users) EU Medical Device Regulations 3
E Callout of a length dimension and then P.I at the end - What does that mean? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 2
K Biocompatability on End Component Other Medical Device and Orthopedic Related Topics 1
T Will the End of Windows XP Support affect anything in AS9100? AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 5
R End of Fake ISO 13485 Certificates? ISO 13485:2016 - Medical Device Quality Management Systems 0
A Device End Of Life Regulations and Requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
hogheavenfarm Allowable End Gap of Split Lockwashers Manufacturing and Related Processes 2
M SOP for Egg Washing at the user end in the Catering Industry Food Safety - ISO 22000, HACCP (21 CFR 120) 4
J The end of the world is nigh!!! Coffee Break and Water Cooler Discussions 41
T End of Line Testers - When to use Red Rabbits? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 2
M Justification for Month End Calibration Date Calibration Frequency (Interval) 9
B Need ideas for a friendly bet - Year-end food drive Coffee Break and Water Cooler Discussions 6
M Calibration of measurement equipment when product End Of Life is near General Measurement Device and Calibration Topics 2
B End of Contract Notice to Employer Career and Occupation Discussions 11
M 8.2.1.1 - Customer Satisfaction - How to satisfy the end requirement? IATF 16949 - Automotive Quality Systems Standard 1
optomist1 Feature Control Frame is applied to the end of a Cylinder - Datum Dilemma Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
T Outsourcing Shipping Product directly from our Warehouse to the End Customer ISO 13485:2016 - Medical Device Quality Management Systems 2
N 1st Shift vs. 2nd Shift Production Crews - How to end this war? Career and Occupation Discussions 15
N Doubt on Bias study for EOLT (End Of Line Tester) Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 2
V PPAPing an end of line Motor Tester APQP and PPAP 2
A When does a project end inside a software product? Life Cycle issue IEC 62304 - Medical Device Software Life Cycle Processes 5
T Reducing End of the Line Skipped Rabbit Testing Reliability Analysis - Predictions, Testing and Standards 3
N Gage R&R on an EOLT (End Of Line Tester) - Include Reference or not? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 6
B Performance Qualification Question - Downsizing the end of a tube Quality Tools, Improvement and Analysis 5
J Tracking the End Customer by Distributors 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
G How do OEM's manage Special Customer Requirements from its End Customers? Customer and Company Specific Requirements 1
F Replacing End of Life (EOL) Components - What triggers retesting to IEC 60601-1 IEC 60601 - Medical Electrical Equipment Safety Standards Series 6
Similar threads


















































Top Bottom