Devices & Diagnostics, MedCity Influencers

Medical device standards group bans industry representatives

A global group of regulators who create standards for new innovative medical devices has dissolved and started over without trade groups as members. The medical device industry group includes the U.S. Food & Drug Administration and other regulators from Japan, Europe, Canada and Australia.

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.


MassDevice Staff

The Massachusetts Medical Devices Journal is the online journal of the medical devices industry in the Commonwealth and New England, providing day-to-day coverage of the devices that save lives, the people behind them, and the burgeoning trends and developments within the industry.

This post appears through the MedCity Influencers program. Anyone can publish their perspective on business and innovation in healthcare on MedCity News through MedCity Influencers. Click here to find out how.

Shares0
Shares0