Posts tagged with "regulatory requirements"

16. April 2019
The ThaiFDA has issued the amended Medical Device Act (Issue 2) B.E. 2562 (2019), which will come into effect in October 2019. This second version supersedes the initial Medical Device Act BE 2008.

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.

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

01. November 2017
The first detailed list of products under the new 2107 regulations including their classification is now available.

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

31. January 2017
A further step towards fixed medical device registration requirements for India...