Global Harmonization and the Link between ISO 13485:2016 and MDSAP

Global Harmonization and the Link between ISO 13485:2016 and MDSAP

Kari Miller, Vice President of Regulatory & Product Management, Pilgrim Quality Solutions

Let’s face it. The world of trade is shrinking. It’s no longer enough to design, build, and distribute a product in compliance with the manufacturer’s national regulations. Within each phase of product development, the manufacturer must abide by global regulations as well. If you’re a medical device manufacturer, and you haven’t started looking at ISO 13485:2016 and the Medical Device Single Audit Program (MDSAP), you’re running out of time!

What is the significance of being up-to-speed on both of these industry efforts at the same time? As the MDSAP goes into full swing this year, medical device manufacturers will notice that MDSAP auditors are looking closely for any instances where the organization demonstrates failure to fulfill any of the requirements of the universal standard — ISO 13485:2016.

Discover how closely we’re related.

Regulators around the world commonly assess product design to ensure safety and efficacy in medical devices. Worldwide, regulatory bodies are looking to ensure sustainability; they need to “see” that an organization can continuously produce and provide safe, quality product to their market. How do they do that? By auditing an organization’s quality system.

But regulatory bodies cannot cover the entire globe effectively or efficiently, so it is in their best interest to harmonize their standards, to ensure that proper oversight is being achieved through collaboration with other regulatory bodies.

Consider that the global MDSAP program basically uses ISO 13485:2016 as a framework, in addition to Good Manufacturing Practice (GMP) requirements of the various countries’ regulatory authorities.

So to ensure patient safety and product performance (fit for use), the trend we’re seeing with MDSAP, ISO 13485:2016, Part 820, and European Medical Device Regulation (EU MDR), and the move toward similarity, and the reference to, or inclusion of, other standards is going to continue. If you’re a medical device company or supplier, for your growth, productivity and compliance, consider the benefits of ISO 13485:2016 and the regulatory backbone it provides you on a global scale.

Check the world calendar.

Even if you’ve only operated and sold within the United States and Part 820 has been your guide, there is good reason to look at ISO 13485:2016 as the trend towards harmonized standards is evident and the world is in fact getting smaller.

Suppose your U.S.-based company does indeed sell and operate in Canada or Europe. You have even more to consider, as Health CANADA (CMDCAS) has a very aggressive timeline for instituting MDSAP and therefore requirements for ISO 13485:2016 compliance. And now that EU MDR is here, which also requires ISO 13485:2016, any manufacturer doing business within the EU has even more reason to look at both MDSAP and ISO 13485:2016.

If you already do business worldwide, or if your organization is European-based, adherence to ISO 13485:2016 is required by March 2019 for all existing products; all new products must be in compliance with the current standard by March 2018. So if your organization intends to introduce new products onto the market, or into new geographic markets, within the next 9-21 months, ISO 13485:2016 must receive some mindshare in your production and distribution strategy.

It can be very time consuming to keep track of requirements on a global scale because deadlines are staggered. The chart below summarizes what’s to come:

ISO 13485:2016 Table
As mentioned above, the EU has more activity in terms of regulatory changes (MDR and ISO 13485:2016), and Canada has a slightly different approach in terms of implementation timelines — they will only accept MDSAP audits after January 1, 2019 — whereas the U.S., Brazil, Australia, and Japan will allow organizations to choose between MDSAP and country-specific audits beginning this year.

Stay compliant to stay in the game.

The bottom line is that the standards are moving towards global harmonization. So even if you’ve never considered ISO 13485 before, your organization should look at it now. Even if you’ve only manufactured and distributed product within the U.S., and 21 CFR Part 820 has been your guide to this point, your organization should take a close look at ISO 13485:2016 now. You’ll discover that, in fact, Part 820 and ISO 13485:2016 are more alike than different today.

The world of trade is shrinking, and so is the world of regulatory compliance. The clock is ticking, so if you want to stay in the game, stay up-to-date on global requirements.


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Kari Miller

Regulatory & Product Management Leader, IQVIA Quality Compliance