01. Dezember 2018
Australian TGA reclassifies the surgical mesh products from IIb to Class III

20. November 2018
The EU Commission previously published the factsheet for EU based medical device Manufacturers that is now amended by two further factsheets for Non EU Authorities and economic operators.

01. November 2018
Update of the Borderline Products Guidance issued by the EU-Commission introducing 5 new borderline products.

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

01. September 2018
As of September 1st 2018 the new name of the organization responsible for Medical devices in China is "National Medical products Administration" (NMPA) replacing the former China Food and Drug Administration (CFDA). The new website www.nmpa.gov.cn of the administration now active. NMPA is an organization under the "State Administration for Market Regulation" (SAMR) that was found in March 2018 integrating the former: State Administration for industry and commerce of the PRC (SAIC) General...

27. August 2018
A notice published by ISO indicates that the FDA may be considering to replace the Current Quality System requirements (as published under 21CFR820) by the ISO 13485 already in 2019. This would create a further step to the global harmonization....

21. August 2018
Health Canada is introducing a new structure for the submission of device license information of class III and IV products following the INDRF Guidance on nIVD(MA)ToC.

01. August 2018
The annual update or the FDA user fees is now available on the FDA Website.

30. Juli 2018
A brief presentation prepared by the EU Commission answers the typical questions concerning the preparation of the Notified Bodies under the new MDR.

24. Juli 2018
In preparing the implementation of the new MDR requirements manufacturers should consider this Checklist prepared by the MHRA.

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