This piece was originally published in the November 2016 issue of electroindustry.
Hans Beinke, Chair, MITA Global Affairs Committee
Just 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 in-house 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 this foundation and expand its successes.Read the November 2016 issue of electroindustry.