Global Medical Technology Alliance
Governance Framework
January 2013
MissionMembers of the Global Medical Technology Alliance (GMTA) support theobjectives of providing safe, effective and innovative medical technology thatsaves and enhances lives, benefiting people and society. The GMTA is a forum
in which members exchange information and jointly develop and advocate
policies that encourage innovation to address patients’ healthcare needs. 1
Objectives
The objects or purpose of GMTA include:•Development and dissemination of information pertaining to medicaltechnology policies and issues on a global basis•Coordination of common policy positions for effective representation at a
global level of the medical technology industry, generally and in forums
such as World Health Organization (WHO), World Bank (WB), WorldIntellectual Property Organization (WIPO), and World Trade Organization(WTO)•

Encouragement of an international policy environment that supports thedevelopment of the medical technology industry, including harmonised
regulatory systems, appropriate payment levels, efficient coveragedetermination systems, patient access to medical technologies, and astrong intellectual property system to support technology research anddevelopment and promote equitable access to medical devices•

Promotion of, and support for, principles of ethical conduct and practices
in the marketing and distribution of medical technology products•

Liaison with other international bodies such as patient associations andprofessional societies, and1

“Medical technology” is used here to mean medical devices, medical equipment and diagnostic products.
This term does not include pharmaceuticals or vaccines.

1•Support for, and/or liaison with, international collaborative forums that canadvance the GMTA Mission, such as the International Medical Device
Regulators Forum (IMDRF), the Global Medical Device Nomenclature
Agency (GMDN), Asian Harmonization Working Party (AHWP), Latin
American Harmonization Working Party (LAHWP), Health Technology
Assessment International (HTAi), and the International Society for
Pharmacoeconomics and Outcomes Research (ISPOR).

Membership(a)Full members•

National medical technology associations which are formally constitutedorganisations comprised of companies which manufacture or supply
medical technology•

Regional medical technology associations which are formally constitutedorganisations comprised of national associations and/or companies which
manufacture or supply medical technology•Associations from the same national or regional area which are formallyconstituted organisations comprised of national associations and/orcompanies from a specialist industry sector (eg. devices, imaging,diagnostics)

(b)
•(c)
•Associate members
Formally constituted organisations which provide business representation
at a national level and which provide support to the medical technology
industry but which are not specialist medical technology associations (egmedical device committees of national chambers of commerce)
Affiliate members
Formally constituted organisations that are not full members but which
support the operations of the industry (eg. GS1 Healthcare).

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Membership criteria(a)Full members

The criteria for full membership include:•Each member association must have a code of business practices
consistent with the GMTA objective of supporting principles of ethicalconduct and practices in the marketing and distribution of medical
technology products•

The member association must be representative of the medical
technology industry in its territory by virtue of the number of members,
diversity of members, and period for which it has been established•

Agreement to accept and abide by GMTA’s governance framework.

(b)

Associate members

The criteria for associate membership include:•(c)Agreement to accept and abide by GMTA’s governance framework.
Affiliate members

The criteria for affiliate membership include:•Agreement to accept and abide by GMTA’s governance framework.

A potential member must submit a formal application in writing to the co-chairs ofGMTA (see footnote 2) who will determine the eligibility of the applicant. The
members of GMTA will formally accept or reject the application at the next GMTA
meeting following submission of the application.
Policy development
The following process applies for development and adherence to policy positionsof GMTA.

3Any GMTA member may present a draft policy paper for consideration by GMTA
members. The paper should define the issue, provide background and present
recommendations for GMTA consideration.
If the member wants the paper to be considered for discussion at the next GMTA
meeting, the paper must be distributed at least 30 days in advance to allow
members to consult their members. The paper should be sent to the current
chair 2 of the GMTA for immediate distribution to the entire membership. The
paper will be discussed at the meeting, with a timetable established for decision
making. The sponsor must also indicate how the proposal would be used – e.g.,
for a specific upcoming meeting of an international organization, for generaladvocacy with third parties, or for internal GMTA use.
Decision Making
The members of GMTA have agreed to an opt-in process for decision-making, inwhich a GMTA member must indicate to the GMTA chair that it is prepared toaccept a proposal on behalf of the member association.
After a proposal is debated and, if needed, revised, the chair or the proponent
may solicit each member’s support. A member may, at that time, indicate: (a)support; (b) non-support; (c) still considering. If five or more GMTA members 3,with broad representation across GMTA geographies indicate their support – andno sustained opposition – then the GMTA logo may be affixed to the proposal,
and the document then becomes an official GMTA document.
If the GMTA approves a particular policy proposal, any members that could notinitially support a proposal could opt-in at a later date. That is, those GMTA
members in the (b) or (c) categories could indicate support when theirmembership has given approval.

2The chair currently alternates between AdvaMed and Eucomed, with each association chairing GMTA forsix months with AdvaMed from March to October, and Eucomed from October to the following March.
3
One of the main purposes of the GMTA is to reflect the medical technology industry’s views on a globalbasis. In that respect, associations in the GMTA should have members that operate internationally and notsell just in their respective home country markets.

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Use of GMTA name and logo
Except as provided in this clause, no individual member of GMTA may use theGMTA logo or name or purport to represent GMTA. The logo and name may
only be used on material reflecting the consensus position of GMTA members(as outlined in the previous paragraph), and to represent collective GMTA views
and advocacy as agreed by GMTA members. A full member may use the logo
and name on its website with a link to the GMTA website, to denote membershipof GMTA. If the member ceases to be a member of GMTA it must immediately
remove the logo, name and link to the GMTA website.

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