Posts tagged with "MDSAP"

01. September 2020
The MDSAP Council published the new "Audit Approach": MDSAP AU P0002.005. This document is combining the previous "Audit Model" and the "Companion Document" into a single source. At the same time the new "audit approach" replaces the previous documents latest 2020-09-30. It is important to notice that the text of the "audit tasks" and "criteria" have not been changed. The new document now includes 2 new annexes with further information concerning the national legislation of the member...

28. January 2020
ANMAT has been recognized as an affiliate member of the Single Medical Device Audit Program (MDSAP) by unanimous decision of the members of the board that comprise it. Although not being a full member of the MDSAP-Program the affiliate status allows the regulators at the Argentinien ANMAT to consider the results of the MDSAP audit, such as the report and certificate as a proof of evidence for compliance with the quality system requirements as applicable for Argentina.

06. September 2018
DEKRA and SGS became fully recognized MDSAP audition Organizations.

13. April 2018
DEKRA and SGS became fully recognized MDSAP audition Organizations.

22. January 2018
Anvisa expands the validity of registrations for Brazil from previously 5 years to now 10 years!

31. October 2017
As announced by Health Canada in its document 17-112120-288 a reduction of the audit time for MDSAP audits is suitable for small organizations to the following extent: 10% for <45 FTE 20% for <15 FTE

29. September 2017
By publishing RDC 179/2017 ANVISA introduces 3 options of showing compliance to the Brazilian GMP requirements.