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Prepare for MDSAP Audits Cheat Sheet by

Medical Device Single Audit Program
medical     program     device     prepare     mdsap     audits


The clock is ticking for medical device manufa­cturers worldwide. Manufa­cturers that want to continue selling products in Canada’s $6.7 billion medical device market should be preparing and planning for the intern­ational Medical Device Single Audit Program (MDSAP) by now. Canada is the first market to require the MDSAP audit as part of its medical device licensing scheme, beginning Jan. 1, 2019. On that date, companies selling Class II, III, and IV medical devices and IVDs must have an MDSAP Certif­icate on file with Health Canada to maintain their Canadian Device Licenses.

Companies that aren’t already prepared for MDSAP, can get started by following four steps.

1. Learn about MDSAP

Enter “MDSAP” into any search engine for general inform­ation. Each of the five jurisd­ict­ions’ regulatory authority websites provide helpful inform­ati­on—the FDA site as well as Austra­lia’s Therap­eutic Goods Admini­str­ation, Brazil’s ANVISA, Canada’s Health Canada, and Japan’s Pharma­ceu­tical and Medical Devices Agency. The FDA website, which is the Regulatory Consor­tium’s official site, offers a compre­hensive overview of the program while highlights essential components and important details, including the MDSAP audit structure.

2. Conduct a Gap Analysis.

Also known as a needs assess­ment, a gap analysis is used to determine what an organi­zation must do to move from its current state—in this case, meeting existing medical device certif­ication requir­eme­nts—to a future standard (i.e. compliance with ISO 13485:2016 and any specific country requir­eme­nts). MDSAP tools such as the Audit Model provide a process map to verify the inclus­ion­/im­ple­men­tation of regulatory requir­ements following ISO 13485:­2016.

The Audit Model and the Audit Model Companion Guidance document should not be relied upon for exact regulatory requir­ements because slight discre­pancies exist. Instead, the model and guidance document should be used as a reference and an audit prepar­ation tool. It is essential to read the regula­tions of the five jurisd­ictions for specifics on each. The FDA website includes an MDSAP Frequently Asked Questions document which is also quite useful.

MDSAP Audits

3. Take Action Based on the Gap Analysis

Prioritize actions to address areas of greatest urgency first.

Understand the regulatory requir­ements thoroughly to avoid mistakenly placed resources and insuff­icient implem­ent­ation.
Perform a proper root cause analysis wherever discre­pancies exist to understand what and/or why something happened.
Fix any problems and implement corrective actions to ensure they don’t recur.
Use the “verif­ication of effect­ive­ness” process to ensure successful implem­ent­ation. This process is widely misund­erstood and often incorr­ectly performed, but it’s an essential step in analyzing QMS health.
Acquire, leverage, and approve needed resources while ensuring that management unders­tands the costs (time and money) needed to implement the requir­ements.
Acquire necessary training for respon­sible parties.
Assume ownership (along with top manage­ment) of the QMS.

4. Choose an authorized Auditing Organi­zation

The FDA website includes a list of all AOs authorized to conduct MDSAP audits. Be sure to consider factors such as expertise, cost, availa­bility, and experi­ence. Schedule the audit no later than September 2018 in order to ensure ample time to utilize that audit for Health Canada Licensing purposes.

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