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Global Harmonization of Med-Tech Quality Guidelines

Creating medical technology for the world market requires meeting various regulations set forth by different governing bodies. Here we look at how global harmonization of med-tech quality guidelines has made this process easier and where divergences still exist.

One of the most difficult aspects of creating advanced medical technology for the treatment and management of diabetes is meeting the various guidelines regulating its development around the world.

When every country enforces slightly different regulations on this kind of complex technology, it creates a massive burden for companies. The amount of paperwork and trying to understand multiple complex documents quickly becomes more difficult than developing the highly intelligent software and devices these guidelines are meant to control.

Luckily, we are seeing more and more regulating bodies trending toward the adoption of a single standardization to govern med-tech development. The Food and Drug Administration (FDA), the last major holdout of this trend toward global harmonization, has finally begun the process of adopting international standard ISO 13485.

In this article, we will take a closer look at this standardization and how it has been implemented around the world, as well as how it is expected to change the regulations currently in place by the FDA.

Europe’s Medical Device Directive

The EU has 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.

Working off of the EU’s documentation and their harmonized approach to regulating medical devices, the International Organization for Standardization (ISO) created ISO 13485 in 1996.

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. Having this type of harmonization in the regulatory process immediately removes the pressure from med-tech companies by giving them a single pathway toward approval that can be applied to multiple markets.

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.

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 in requirements have long made it difficult for companies hoping to market their product in the US and abroad, to achieve clearance in all markets without investing huge amounts of time and money.

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 Global Harmonization

Even without the delays in implementing this transition due to COVID-19 and other factors, this was never going to be a quick 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 to reflect the changes required of ISO 13485 now, will set your organization up for success as true global harmonization of med-tech quality guidelines becomes a reality.

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