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

27. März 2018
Guidance for the update of the "Betreiberverordnung"

27. März 2018
Following the reform plan of the State Council "China Food and Drug Administration is merged with the NHFPC and the GAQSIQ into the State Market Regulatory Administration.

22. Januar 2018
After the Brexit manufacturers need to find a new Authorized representative and a new Notified Body if they use these service Providers in the UK.

18. Januar 2018
FAQ for the application and transition of the MDR (EU)2017/745

29. Dezember 2017
Health Canada updates the guidance "Application for new medical devices"

07. Dezember 2017
The Borderline Working group chaired by the EU Commission published the updated Version 1.18 of the "MANUAL ON BORDERLINE AND CLASSIFICATION IN THE COMMUNITY REGULATORY FRAMEWORK FOR MEDICAL DEVICES". The document is intended to act as a guidance for the interpretation of the MDD and IVD. The new paragraphs introduced by the updated are identified by the Picture "New". Important notice: This document is not applicable under the MDR unless further updates will integrate the reference to the (EU)...

04. Dezember 2017
The Australian Authorities published the new fees applicable to medical devices as of December 4th, 2017. The table with applicable fees is available on the TGA Website.

29. November 2017
The newly published document on the "AO Availability to Conduct MDSAP Audits" still only includes 4 Auditing organizations that were recognized by the Council in full: BSI Group America Inc. Intertek Testing Services NA Inc. TÜV Süd America Inc. UL Medical and Regulatory Services Inc. The other 10 Auditing Organizations on the list still need to finish the last steps for recognition.

26. November 2017
Switzerland paves the road for the implementation of the MDR requirements into national legislation.

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