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Regulatory News | 25 April 2019 | By Ana Mulero
"We have not opened it further for other countries at this time because we are still trying to work through a lot of kinks in the program itself," said Torres. "Adding a country means revising the entire audit model, which then increases the length of the audit and length of the audit is something we've been criticized about already so there has to be a balance." She added that a key factors is that every participating country has to have a confidentiality agreement with each other and this presents some challenges so in other countries that do not.
IMDRF intends to publish the category of MDSAP membership in upcoming weeks. This will encourage other countries to use MDSAP audit reports, according to Torres. "We certainly have received a lot of interest from other countries not participating," but more work needs to be done to address some remaining issues first.
Tags: Harmonization, IMDRF, IVD, MDSAP