The International Council of Regulatory Authorities, which established the MDSAP (Medical Device Single Audit Program), announces the launch of the new official platform, mdsap.global. This website centralizes all essential information related to the MDSAP and is intended for medical device manufacturers.
A single point of access to regulatory information
Developed under the auspices of the relevant authorities in Canada, the United States, Brazil, Australia, and Japan, the mdsap.global portal offers:
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a detailed overview of the MDSAP program,
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explanatory materials and educational resources,
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an official directory of authorized audit organizations,
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information on the role of the relevant regulatory authorities.
Its goal: to facilitate access to reliable, consistent, and up-to-date information, while supporting manufacturers in their compliance efforts.
MDSAP: A Single Audit for Multi-Regulatory Compliance
The MDSAP allows medical device manufacturers to undergo a single audit that is recognized simultaneously by multiple regulatory authorities. This harmonized approach significantly simplifies the process for companies seeking to enter international markets, including:
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Health Canada (Canada),
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ANVISA (Brazil),
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TGA (Australia),
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MHLW/PMDA (Japan),
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FDA (United States).
In addition to reducing redundant audits, this program contributes to a more efficient allocation of resources and more effective oversight of the quality and safety of medical devices.