FDA starts Voluntary Audit Report Program for Medical Devices
On 5 June 2012, the FDA has begun a "voluntary program" for medical devices audits entitled "Medical Devices ISO 13485:2003 Voluntary Audit Report Submission Pilot Program" - based on ISO 13485:2003. The purpose is to extend FDA's inspection intervals. Read more.
Half-year Report 2012: FDA Medical Devices Warning Letter Statistics
We regularly analyse the Warning Letters issued by the FDA. The following information presents the current evolution of the Top 5 hit list - with regard to medical devices - for the first half of the fiscal year 2012 (from 1st October 2011 to 15 March 2012). Read more.
The Chinese Ministry of Health has published revised GMP rules for drugs in the beginning of 2011. March 1, 2011 was specified as date for the entry into force. Now, an English translation is available. Read more about the main differences between the Chinese GMP rules and EU GMP Guideline Part I.