MDSAP (Medical Device Single Audit Program) is one of the (too) few harmonization program among different regulation systems.
MDSAP was developed by the International Medical Device Regulators Forum (IMDRF) which identified a work group to develop specific documents for establishing a Medical Device Single Audit Program.
Since January 2014, FDA was participating in a Pilot phase alongside other international partners. The pilot phase ended December 2016 and the formal program begun January 2017.
The MDSAP program 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 program.
International partners that are participating in the program include:
- Food and Drug Administration of United States of America
- Therapeutic Goods Administration of Australia
- Brazil’s Agência Nacional de Vigilância Sanitária
- Health Canada
- Japan’s Ministry of Health, Labour and Welfare, and the Japanese Pharmaceuticals and Medical Devices Agency
- The World Health Organization (WHO) Prequalification of In Vitro Diagnostics (IVDs) Programme and the European Union (EU) are Official Observers
Health Canada has, as of 1 January 2019, terminated their current CMDCAS program and only accept MDSAP certificates.
Following the ISO 13485 version 2016 release, the audit model has been updated and audits can now be conducted according this version of the standard.
The MDSAP program information and supporting documentation are hosted on this FDA webpage. It contains for instance procedures and policies, audit model, companion, forms and also training material. It should be noted, however, that the documentation is mostly designed for the auditing organizations (including the training material). A Q&A document is also available.
How is considered MDSAP by participating Regulatory Agencies ?
MDSAP should be considered for businesses having worldwide footprint, if they wish to export devices into the countries taking part in the program, as defined below.
The five Regulatory Agency’s included in MDSAP pilot are making the subsequent statements regarding how they intend to make use of MDSAP reports:
- Australia: The Therapeutics Goods Administration TGA makes use of the MDSAP audit report as content assessed for compliance with medical device authorization requirements. Except if the medical device is otherwise excluded or exempt from the requirements or in case current policies limit the usage of MDSAP audit reports.
- Brazil: The Brazilian National Health Surveillance Agency ANVISA utilizes the output of the program, like the reports, as a significant input in ANVISA’s pre-market and post-market evaluation process. Providing, when applicable, essential data that is expected to assist regulatory technical assessment on these problems.
- Canada: Health Canada HC have published the obligation for medical device manufacturers to move from CMDCAS to MDSAP to continue to place devices into Canada. From 1st January 2019 Health Canada (HC) only accept MDSAP certificates for manufacturers who want market their devices in Canada. For that reason, manufacturers need to have MDSAP certification issued by an approved auditing organization.
- United States: U.S. Foods and Drug Administration’s Center for Devices and Radiological Health FDA will accept the MDSAP audit records as a substitute for FDA routine inspections. Inspections conducted “For Cause” or “Compliance Follow-up” by FDA are not impacted by the program and will still be conducted by FDA directly. Additionally, the MDSAP program would not apply to any necessary pre-approval or post-approval inspections for Pre-Market Authorization (PMA) apps or decisions under section 513(f)(5) from the Act (21 U.S.C. 360c(f)(5)) about the classification of the device.
- Japan: The Ministry of Health, Labour and Welfare (MHLW) and Pharmaceutical and Medical Devices Agency (PMDA) will use these audit reports in both pre-market and periodical post-market audit under regulations in Japan.
We offer consultation for the implementation of the MDSAP program, training and gap analysis for the changes.