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ARN Forum Dec 2019 II

Washington, D.C., 20 December 2019 (PAHO)-The National Regulatory Authorities (NRA) of Argentina (ANMAT), Colombia (INVIMA), Ecuador (ARCSA), El Salvador (DNM), Guyana (GAFDD), Mexico (COFEPRIS) and Venezuela (INHRR) have participated for the first time of the Single Medical Device Audit Program (MDSAP) Forum, held from 5-6 December 2019 in Washington D.C., USA.

The MDSAP program formed by the NRAs of Brazil (ANVISA), Canada (Health Canada), United States (US FDA), Australia (TGA) and Japan (PMDA) constitutes a pioneering and innovative use of the decisions of these NRAs as it allows that a medical device manufacturer be evaluated by auditing organizations recognized by MDSAP that perform a single regulatory audit of the quality management system (QMS) that meets the relevant requirements of the participating NRA.

The program recently launched the category of affiliated members, which will extend MDSAP benefits to other regulatory authorities. The NRAs of the Region may benefit from such membership that enhances oversight and safety of medical devices, while voiding duplication of efforts, improving the efficiency of regulatory processes and promoting practices of reliance in the Region.