MDSAP (Medical Device Single Control Program) is one of the (very) few harmonization programs between different regulatory systems.
MDSAP was developed by the International Medical Device Regulators Forum (IMDRF), which appointed a working group to develop specific documents to establish a Medical Device Single Audit Program.
Since January 2014, the FDA has been participating in a Pilot phase with other international partners. The pilot phase ended in December 2016 and the official program began in January 2017.
The MDSAP program aims to allow MDSAP-recognized Inspection Bodies to conduct a single inspection of a medical device manufacturer that will meet the relevant requirements of the medical device regulatory authorities participating in the program.
MDSAP participants:
International partners participating in the program:
- 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
As of January 1, 2019, Health Canada discontinued the current CMDCAS program and only accepts MDSAP certifications.
Following the ISO 13485 version 2016 publication, the audit model has been updated and audits can now be performed according to this version of the standard.
MDSAP program information and supporting documents are hosted on this FDA webpage. For example, it includes procedures and policies, audit model, companion, forms, as well as training material. However, it should be noted that the documentation is mostly intended for inspection bodies (including training material). A Q&A document is also available.
How is MDSAP evaluated by Participating Regulators?
MDSAP should be considered for businesses with a worldwide footprint if they want to export devices to countries in the program, as defined below.
The five Regulators included in the MDSAP pilot program make the following statements on how they intend to leverage the MDSAP reports:
- Australia: The Therapeutics Goods Administration TGA uses the MDSAP audit report as content evaluated for compliance with medical device authorization requirements. Except where the medical device is otherwise exempted or exempted from requirements, or where current policies limit the use of MDSAP audit reports.
- Brazil: The Brazilian National Health Surveillance Agency, ANVISA, uses the output of the program, such as the reports, as an important input in ANVISA’s pre-market and post-market evaluation process. Provide baseline data, where applicable, that is expected to assist regulatory technical assessment of these issues.
- Canada: Health Canada HC has issued a requirement for medical device manufacturers to switch from CMDCAS to MDSAP to continue placing devices in Canada. As of January 1, 2019, Health Canada (HC) only accepts MDSAP certifications for manufacturers who wish to market their devices in Canada. For this reason, manufacturers must have an MDSAP certificate issued by an approved inspection body.
- United States: US Food and Drug Administration Center for Devices and Radiological Health FDA will accept MDSAP audit records in place of FDA routine audits. Audits performed by the FDA “For Reason” or “Following Compliance” are not affected by the program and will be conducted directly by the FDA. In addition, the MDSAP program includes any pre-approval or post-approval audits required for Pre-Market Authorization (PMA) applications or section 513(f)(5) of the Code (21 USC 360c(f)(21 USC 360c(f)) ) will not apply to decisions under the scope of. 5)) about the classification of the device.
- Japan: The Ministry of Health, Labor and Welfare (MHLW) and the Pharmaceutical and Medical Devices Agency (PMDA) will use these audit reports for both pre-market and periodic post-market audits under Japanese regulations.
We offer consultancy for MDSAP program implementation, training for changes and GAP analysis.
