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What is MDSAP?

 

Medical Devices Single Audit Program

The International Medical Device Regulators Forum (IMDRF), has identified the value in developing a global approach to auditing and monitoring the manufacturing of medical devices to ensure safe medical devices, and developed a pilot scheme for joint audits covering regulations of USA, Canada, Brazil and Australia. Japan’s MHLW and PMDA are participating as official observers for now.

Pilot Program

This global approach opens possibilities and pathways to support the development of an international initiative of countries dedicated to pooling technology, resources, and services to improve the safety and oversight of medical devices on an international scale in a Pilot Program starting in January 2014. The pilot program will last for 3 years, when it will be evaluated. After the evaluation the program can be launched as a scheme and available to all regulatory authorities that wish to participate.

Watch our Recorded Webinar: Medical Devices Single Audit Program MDSAP for Manufacturers >

MDSAP Auditing

The establishment of the MDSAP includes the use of third party auditors, much like some current regulatory audit programs, as well as regulatory inspectorates. Recognizing the increasingly global nature and number of medical device manufacturers, the use of third party auditors in addition to Regulatory Authority Inspectorates, allows greater coverage in auditing manufacturers as opposed to relying solely on the government resources of individual
countries
 
The MDSAP Pilot is intended to allow MDSAP recognized Auditing Organizations to conduct a single audit of a medical device manufacturer that will satisfy the relevant requirements of the medical device regulatory authorities participating in the pilot program. This may reduce the number of audits, postpone FDA routine inspections and replace a CMDCAS audit.
 
During the pilot, only registrars currently recognized in the Health Canada CMDCAS program can apply for auditing against the MDSAP scheme. SAI Global is one of the very few Auditing Organizations that will be authorized to conduct audits under MDSAP in the near future.

How Do I Participate In The MDSAP Program?

Contact SAI Global to confirm your interest in participating. We will go through your current audit plan and process and help you determine if the MDSAP program is a good option for your organization.
 
 
Links for MDSAP announcements and documents:
 
IMDRF:
 
FDA:
 
Health Canada:
 
Australian Government - Department of Health (TGA):

 

 

 

 

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