By Mark Abdoo
December 1, 2022
(Remarks as prepared for delivery)
Good morning and welcome to the first full gathering of the MDSAP Forum since 2019. I’m Mark Abdoo, Associate Commissioner for Global Policy and Strategy – my office oversees FDA’s global operations, trade and diplomacy activities. Due to a scheduling conflict, I am unable to be there to greet all of you in person. However, I still wanted to say a few words at the outset of this important two-day meeting.
First, I want to begin by thanking the MDSAP Regulatory Authorities – Australia, Brazil, Canada, Japan and the United States – for their continued efforts in improving and promoting the program, especially during the pandemic. I know that many of these countries have done even more to advance harmonization by participating in work groups under the auspices of the IMDRF [International Medical Device Regulators Forum] that aim to duplicate MDSAP’s success.
MDSAP’s executive leadership group – the Regulatory Authority Council – has provided the program with steady leadership and guidance. My special thanks go to the Council and, in particular, Mr. Kenichi Ishibashi of Japan, for his leadership as the council’s chair.
I’d also like to extend my gratitude to the observers from the EU, United Kingdom and the WHO for their continued involvement in the MDSAP program. We value their feedback as we work to improve MDSAP’s operations, and we welcome their assistance in helping to promote the program to further its worldwide adoption. As the program grows, we’ll increasingly rely on their expertise to harmonize and strengthen our efforts.
Turning to the affiliate regulatory authorities, I’d like to welcome Israel, the latest regulatory authority to join Argentina, South Korea and Singapore as affiliate members. I’d like to thank all four of them for participating in the program and using MDSAP certificates and audit reports in their regulatory frameworks. Let me assure you that MDSAP regulatory authorities remain committed to assisting Affiliate members with capacity building and in engaging in fruitful discussions, both inside and outside of this forum, to assist Affiliate members in their missions to protect public health.
Finally, a word to the Auditing Organizations gathered here. Each time we meet as a larger group with the Auditing Organizations, we look forward to your valuable comments and feedback on MDSAP policy and procedures. The Regulatory Authorities cannot successfully improve MDSAP without your input. Moreover, the professional and task-based work of your organizations and auditors has been critical to the success of MDSAP. I know that auditing a facility during the public health emergency has not been easy, but we appreciate your dedication in assisting regulatory authorities to protect public health. So, I thank you.
As you know the Medical Device Single Audit Program was initially established as a pilot to consider whether it was possible to use a single audit of a manufacturing facility to satisfy the relevant requirements of the participating regulatory authorities. Of course, the answer was a resounding yes, and so five years ago MDSAP moved from a pilot program to an established program. Since then, thanks to the dedicated efforts of the Regulatory Authorities, MDSAP Observers, Associate Members and the Auditing Organizations, we’ve seen nothing but continued growth for the program.
Consider these data points. When the permanent program began in the first quarter of 2017, 229 medical device manufacturing sites were registered for MDSAP. By the third quarter of 2022, that number had grown to 6,459 sites – located throughout the world. While a high percentage of these sites - 42% - are located in the United States; a significant portion of them are located elsewhere, including 8% in Germany, 7% in Canada, 6 % in China, and 4 % in Japan. In addition, the United Kingdom, France, Switzerland and South Korea each account for 3% of the MDSAP sites, and Italy and Israel account for 2% of them.
If you add it all up, there have been 16,612 audits submitted via the program since 2017. The number of audits conducted during the pandemic were especially robust. From March 11, 2020, to November 17, 2022, a total of 8,882 audits were submitted. Sixty-two percent of those contained a remote component.
It's not surprising that the program has thrived given its many benefits. It’s been praised for minimizing medical device manufacturer disruptions because of multiple regulatory audits; predictable audit schedules; reducing manufacturer time and resources in dealing with findings from multiple audits; leveraging regulatory resources; improving transparency; and last, but not least, benefiting patient health and patient access as a result of ease of entry to multiple markets.
Of course, what’s further driving these numbers is that Canada began requiring audits via MDSAP for all manufacturing facilities with Class II, III, and IV medical device licenses in 2019.
2021 saw another milestone for MDSAP with the FDA’s announcement of a proposed rule to its medical device quality requirements that is more closely aligned with ISO 13485 the international consensus standard used by many other regulatory authorities around the world, and, of course, the standard used by MDSAP’s auditing organizations. MDSAP played an integral role in helping the FDA develop the draft regulation.
Over the next two days, you’ll hear how countries are using MDSAP, you’ll get updates on important regulatory changes, and you’ll obtain feedback from stakeholders that will help move the program forward in 2023, including how the program will evolve in a post-pandemic world.
These are positive times for MDSAP. Given MDSAP’s many benefits, and the support of all of you, we can foresee continued adoption of MDSAP globally which will promote consistency in the regulation of devices and provide timelier introduction of safe, effective, high-quality devices for patients.
Thank you and I hope you have a great meeting.