One of the greatest challenges in developing advanced medical technology for diabetes care is navigating the complex web of regulatory guidelines across different countries. Each nation enforces slightly different requirements, making the process of compliance as burdensome as designing the intelligent devices themselves.
Fortunately, the industry is moving toward a single, unified framework through the global harmonization of medical device regulations. This shift reduces redundancy and streamlines approval, allowing companies to focus more on innovation than paperwork. Even the FDA, once the primary holdout, has begun aligning with international standard ISO 13485 as part of this broader effort.
In this article, we’ll explore the global harmonization of medical device regulations, its impact on MedTech companies, and how these changes are shaping the future of FDA oversight.
A Closer Look at the Global Harmonization of Medical Device Regulations
To understand the progress being made toward the global harmonization of medical device regulations, it’s important to examine how different regions have approached quality standards.
Europe established consistency early on through the Medical Device Directive, while ISO 13485 expanded that framework internationally. In contrast, the FDA’s Quality System Regulation has long stood apart, creating challenges for companies seeking multi-market approval. The following sections provide a closer examination of each of these systems and their role in establishing a more unified global standard.
Europe’s Medical Device Directive
The EU’s standardized approach laid the groundwork for the global harmonization of medical device regulations by providing a clear, unified framework for quality management.
They have had a standardized approach to med-tech regulation since 1993. Medical devices that meet the conditions of the directive are given a CE marking that allows for the marketing of the product throughout the European Union.
Having a single quality management system (QMS) in place for all countries in the EU has vastly simplified the approval process for companies looking to sell their products in any of these markets.
Building on the EU’s documentation and its harmonized approach to regulating medical devices, the International Organization for Standardization (ISO) developed ISO 13485 in 1996, a significant step toward global harmonization of medical device regulations.
The Broad Reach of ISO 13485
ISO 13485 was quickly adopted by several other countries during the establishment of their own med-tech regulatory guidelines.
Australia, Canada, Japan, Korea, Brazil, and others have all created their own QMS based on this standard. This widespread adoption has been instrumental in advancing the global harmonization of medical device regulations, reducing regulatory complexity for international MedTech companies.
But one country has long been missing from the list of regulatory bodies that have embraced ISO 13485 as the backbone of their QMS: the FDA in the United States. Until recently, it had not fully participated in the global harmonization of medical device regulations.
Now, after repeated delays complicated by COVID-19, it seems the FDA is finally on its way to rewriting its QMS to better align with the current global standard for medical technology quality guidelines.
Quality System Regulation vs ISO 13485
Currently, the FDA uses the guidelines set forth by its Quality System regulation (QSR) to grant clearance to medical devices to be sold in the US marketplace.
This set of regulations was created based on early versions of ISO 13485, but includes additional guidelines that are not mentioned in the international standard, while leaving out some that are. While these two standards do not have conflicting regulations, they are not identical by any means.
These differences highlight the challenges MedTech companies face in achieving global harmonization of medical device regulations while seeking clearance in multiple markets.
In 2018, the FDA announced its intention to transition away from the antiquated version of QSR to a standard that more uniformly aligns with the current version of ISO 13485. In an official release, the FDA recognized the importance of this move for medical technology developers, writing:
“The revisions are intended to reduce compliance and recordkeeping burdens on device manufacturers by harmonizing domestic and international requirements.”
Preparing for the Global Harmonization of Medical Device Regulations
Even without the delays caused by COVID-19, the path toward global harmonization of medical device regulations has always been destined to be a multi-year process. The FDA expects the transition to take years to be fully realized. For med-tech companies currently in the developmental stages, this is sure to cause some headaches.
In order to take advantage of the global harmonization and wide-scale adherence to ISO 13485 that is occurring and to navigate the slow transition from QSR by the FDA, diabetes med-tech companies should seek the experience and knowledge provided by a partner who is well versed in a wide range of quality guideline regulations.
Sequenex has decades of experience dealing with the changing landscape of quality regulation. We are deeply familiar with ISO 13485 and QSR and can help you navigate this shifting landscape as it affects the world of diabetes technology and software. Adapting your quality management systems now ensures your organization is aligned with the global harmonization of medical device regulations and ready for success in international markets.
