Consultation on AMDD “From the Singapore Health Sciences Authority – Updated 2 August 2012 – As part of efforts to enhance economic integration among ASEAN (Association of Southeast Asian Nations) member states, ASEAN has been working on developing a standardised framework
Impact of WEEE2 on Medical Devices Industry
EUCOMED on 25 July 2012 wrote a nice summary of the Impact on the Medical Devices Industry of the long awaited revision of the Waste Electrical and Electronic Equipment (WEEE2 or WEEE recast) Directive (2012/19/EU) was published in the EU
Amendment 1 of IEC 60601-1:05 (3rd edition) has been published by IEC
On 13 July 2012 IEC formally published the long awaited IEC 60601-1:05 (also known as third edition) Amendment 1 (A1). It is available on the IEC.ch website’s store. Refer to my previous post of 11 July announcing the imminent release
JIS T 0601-1:2012 Just Published (Japan’s National Version of IEC 60601-1:2005)
On June 1, 2012 Japan issued their national version of IEC 60601-1:2005 (or 3rd ed.). The transition period has started as of June 1, 2012 but I am still determining what products under Japan’s MHLW’s (Ministry of Health, Labour
Update on National Implementations of IEC 60601-1:2005
This article was written by Leo Eisner and is featured in the Journal for Medical Device Regulations in their May 2012 edition. It is the top article on our Featured Articles WebPage. This article is on the National Implementations of