NEMA ei November 2016 - 13MITA


Setting a Global Priority:
Test Once, Sell Everywhere

MITA

Strategic Priority 5:
Reduce costs to global business
and support growth in strategic
global markets

Hans Beinke, Vice President, U.S.A. Country Head, Quality
& Technology, Siemens Healthcare
Mr. Beinke chairs the MITA Global Affairs Committee.

J

ust as MITA works with Congress and the U.S. Food
and Drug Administration to improve regulatory
and business conditions, its Global Affairs Committee
(GAC) works with partners in an increasingly
interconnected world to streamline regulatory
procedures and strengthen members' businesses.
When threats to global business emerge or countries
enact barriers to restrict access to markets, the GAC
moves quickly to understand the problem, determine
how to resolve it, and work toward a solution. Its
strategic focus is to reduce the costs and complexity of
international business and to unlock potential in new
and growing markets.
As countries around the world develop their health
systems, they increasingly focus on regulating medical
devices. This, in turn, leads to a proliferation of
inconsistent and diverse regulatory requirements that
may introduce unnecessary costs but which with which
manufacturers must comply.
We set a lofty goal: test once, sell everywhere. MITA
envisions a future where compliance with one set
of requirements would allow a product to be sold
in multiple countries. Achieving this goal requires
partnerships and collaborations with industry groups
in other countries. Under MITA's leadership, DITTA
(the global Diagnostic Imaging, Healthcare IT, and
Radiation Therapy Trade Association) was formally
incorporated in 2012.
Through DITTA, we have brought "test once, sell
everywhere" closer to reality by working with the
International Medical Device Regulators Forum
(IMDRF), a group of regulators whose goal is to
converge global medical device regulations toward a
single set of commonly-accepted requirements and
processes. We've seen success: IMDRF published
common guidance on the regulation of medical
software and a global standard for unique device
identifiers. It also is piloting a program for a single
quality-management audit and a common structure for
regulatory submissions.
Concerted industry efforts have led to discussions
among regulators on a common dossier review that
would bring regulators closer to agreement on what

they require in a marketing application and how they
review it. This step would have been unthinkable 10
years ago.
We are not content to observe and react. We are
proactive about reducing the scope of global patient
registries and clinical trials requirements. For example,
MITA worked with the World Health Organization
(WHO) to implement a common global regulatory
framework and to avoid the costly proliferation of
divergent regulations as emerging countries begin to
regulate their medical device markets.
Growing new markets is a priority for the GAC. To be
effective, we look for areas in which we can have the
maximum impact with minimum time and resources.
Refurbished systems represent a growing source of
revenue for MITA members, yet the import and sale
of refurbished equipment is banned in some markets
with high growth capacity. To unlock this potential, we
published NEMA/MITA 1-2015 Good Refurbishment
Practices for Medical Imaging Equipment and
introduced a standards-based, regulated approach to
refurbished systems instead of outright bans.
Educating aid organizations on the importance
and value of medical imaging is another area where
minimal efforts can lead to big impacts. Currently,
organizations that build capacity and fund healthcare
systems in emerging countries have little or no inhouse expertise on medical devices or imaging. This
leads to deficient tenders, ineffective purchasing, and
allocation of funds that ignore
the lifesaving potential of
early detection.
These first steps
with major global
players may be
small, but they are
significant. MITA,
which will chair
DITTA in 2017-
2018, is set to build
on its success. ei

MITA

13

www.nema.org  *  November 2016


http://www.nema.org

Table of Contents for the Digital Edition of NEMA ei November 2016

Comments from the President
Breaking News
Survey: Benchmarking, Transparency Work
Centerfold: A look inside the Medical Imaging & Technology Alliance (MITA), a division of NEMA
2017 NEC Broadens Requirements for SPDs
Power Surges: Protect Your Home!
Grid Modernization Promotes Sustainability
Advocacy
Code & Standards
Revision Simplifies Magnet Wire Production
International
Business Analysis
NEMA ei November 2016 - Cover1
NEMA ei November 2016 - Cover2
NEMA ei November 2016 - 1
NEMA ei November 2016 - 2
NEMA ei November 2016 - 3
NEMA ei November 2016 - 4
NEMA ei November 2016 - Comments from the President
NEMA ei November 2016 - Breaking News
NEMA ei November 2016 - 7
NEMA ei November 2016 - Survey: Benchmarking, Transparency Work
NEMA ei November 2016 - 9
NEMA ei November 2016 - 10
NEMA ei November 2016 - 11
NEMA ei November 2016 - 12
NEMA ei November 2016 - Centerfold: A look inside the Medical Imaging & Technology Alliance (MITA), a division of NEMA
NEMA ei November 2016 - 2MITA
NEMA ei November 2016 - 3MITA
NEMA ei November 2016 - 4MITA
NEMA ei November 2016 - 5MITA
NEMA ei November 2016 - 6MITA
NEMA ei November 2016 - 7MITA
NEMA ei November 2016 - 8MITA
NEMA ei November 2016 - 9MITA
NEMA ei November 2016 - 10MITA
NEMA ei November 2016 - 11MITA
NEMA ei November 2016 - 12MITA
NEMA ei November 2016 - 13MITA
NEMA ei November 2016 - 14MITA
NEMA ei November 2016 - 15MITA
NEMA ei November 2016 - 16MITA
NEMA ei November 2016 - 2017 NEC Broadens Requirements for SPDs
NEMA ei November 2016 - 14
NEMA ei November 2016 - 15
NEMA ei November 2016 - Power Surges: Protect Your Home!
NEMA ei November 2016 - 17
NEMA ei November 2016 - 18
NEMA ei November 2016 - 19
NEMA ei November 2016 - Advocacy
NEMA ei November 2016 - 21
NEMA ei November 2016 - Code & Standards
NEMA ei November 2016 - Revision Simplifies Magnet Wire Production
NEMA ei November 2016 - 24
NEMA ei November 2016 - International
NEMA ei November 2016 - Business Analysis
NEMA ei November 2016 - 27
NEMA ei November 2016 - 28
NEMA ei November 2016 - Cover3
NEMA ei November 2016 - Cover4
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