South Korea (Ministry of Food and Drug Safety) first and now Argentina (ANMAT) have very recently joined the MDSAP program as affiliated members.
Although not an observer, like the WHO or the European Union, nor a member of the consortium of regulatory authorities at the initiative of the program (Regulatory Authorities Consortium /RAC = Australia, Brazil, Canada, Japan, United States), this special status, created in 2019, define a framework within which a country can utilize the MDSAP audit reports or certificates to evaluate a medical device manufacturer’s quality management system under its own regulation.
This is a very positive perspective for companies certified by GMED and more generally for all of the more 5,000 sites audited under the MDSAP program.
After the approval of their formal application, MDSAP Affiliated Members shall demonstrate an understanding of the program MDSAP by completing the on-line training materials and by staying up to date with the MDSAP policy documents. They have to report annually the utilization of MDSAP report(s) and/or MDSAP certificate(s) to the RAC.
MDSAP Affiliated Members will be invited to attend sessions of the annual MDSAP Forum open to medical device industry,
MDSAP Affiliated Members will be regularly granted access to an extract of the MDSAP master list (the manufacturer’s information, the manufacturing site, audit dates, and the corresponding recognized auditing organization/AO).
As they will not have access to the MDSAP database on the Regulatory Exchange Platform – (REPs) hosted on the secured web portal, they will contact manufacturers in order to receive MDSAP audit report(s) and/or MDSAP certificate(s).
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