Author: Dr. Suzanne Broussard

MDSAP as a Single Regulatory Audit 

The Medical Device Single Audit Program (MDSAP) is now in year three of voluntarily allowing medical device manufacturers to satisfy requirements of multiple regulatory jurisdictions with a single audit. Understanding the basics of MDSAP is the first step to determining if this is right for your organization.  

Device manufacturers are starting to accept this more harmonized auditing program, with over 2,700 manufacturers having undergone an MDSAP audit as of December 2018 (Figure 1). The significant increase in audits in 2018 reflects Health Canada’s hard deadline of January 1, 2019 for device manufacturers to comply with MDSAP in order to sell medical devices in Canada. While there were plenty of concerns about the transition, Health Canada received over 3,000 MDSAP certifications or transition submissions accounting for 90% of medical manufacturers operating in Canada. The remaining 10% are companies with very low or no sales, meaning they may likely pull out of the market.  

Several early adaptors are lauding the MDSAP program for saving time and limiting company resources needed for auditing agencies. These outcomes are in line with IMDRF’s primary goals for creating MDSAP, which are to “…jointly leverage regulatory resources to manage an efficient, effective, and sustainable single audit program focused on the oversight of medical device manufacturers.”  

If you are one of the many medical devices manufacturers that have not yet embraced MDSAP, industry experts suggest it is time to get started! This single audit via MDSAP provides an opportunity for companies to reap the benefits of reduced audits from agencies in multiple jurisdictions if they sell products in participating countries. 

Keep in mind that MDSAP does not place a single new requirement on device manufacturers. What MDSAP does is place requirements on the Auditing Organizations (AOs) dictating how to consistently perform an audit. Essentially, AOs are approved by regulatory agencies to perform audits after a rigorous process to prove competency. These AOs are charged with performing the audit in a manner that is consistent and predictable while giving a high degree of confidence that the manufacturer is in complete compliance.   

FDA Touts the Benefits of MDSAP 

Even regulatory authorities like the FDA are promoting the many benefits of MDSAP. 

• MDSAP routine audits are announced in advance by the scheduling AO and have a pre-established duration. 
• Manufacturers have one full month to respond to AOs for critical nonconformities (grade 4 and 5) compared to only 15 working days after an FDA inspection. 
• MDSAP Certification documents may provide a marketing advantage. 

Is Your Organization Ready to Transition to MDSAP?  

Some companies that have gone through the process claim that they found the process easier than going through an FDA audit once they embraced MDSAP. Why? Because, the MDSAP audit is performed in a specific order that is predictable and clearly outlined. This approach is very different than an FDA or ISO audit, which are much less predictable. Company testimonials on the FDA MDSAP site claim transition to MDSAP save costs internally with less disruption.  This sentiment is shared by other industry leaders who applaud the prescriptive nature of the MDSAP audits. 

There are no surprises at MDSAP audits  

IMDRF provides device manufacturers with everything required to understand and prepare for MDSAP. A plethora of resources that explain the program in more detail and help prepare for an MDSAP audit are available on FDA’s website. Best of all—they are free! 

The most helpful resources are the MDSAP Companion Document and the MDSAP Audit Model.  

• Both these forms provide detailed information that directly corresponds with the MDSAP audit.  
• There is a section in the documents to explain what should happen at each step of the audit.
• Requirements are asked by auditors in the order presented and the flow does not vary allowing the manufacturer to better plan the audit.  

If your organization sells medical devices in multiple participating countries and already maintains a high level of compliance, transitioning to MDSAP is worth considering.