By Stewart Eisenhart, Emergo Group
Emergo Group
Changes to Health Canada’s list of recognized standards
By Stewart Eisenhart, Emergo Group
Medical device market regulators in Canada have added 11 new items to their list of recognized standards, removed six and amended another 27.
Standards newly recognized by Health Canada include IEC and ISO standards covering various electrical medical device components, implantable devices and IVDs.
U.S. FDA shares more details on MDSAP international audit pilot
By Stewart Eisenhart, Emergo Group
U.K. regulators requiring public registration of medical device clinical investigations
By Stewart Eisenhart, Emergo Group
Healthcare regulators in the UK are now requiring medical device manufacturers and sponsors to register their clinical trials in publicly accessible databases such as the EU Clinical Trials Register or ClinicalTrials.gov in the US.
Single QMS audit program pilot for medical devices set for January 2014
By Stewart Eisenhart, Emergo Group
Medical device market regulators in Australia, Brazil, Canada and the US are preparing to launch a pilot for their Medical Device Single Audit Program (MDSAP) in January 2014.
Chinese regulators considering new clinical trial, adverse event reporting requirements
By Stewart Eisenhart, Emergo Group
Chinese medical device market regulators are three years away from full implementation of a new adverse event reporting and monitoring system, and may also establish a new clinical trial approval process for high-risk devices.
MPO: Top 5 medical device manufacturers face market uncertainties in the U.S. and Europe
By Stewart Eisenhart, Emergo Group
Every year our friends at Medical Product Outsourcing put out a list of the 30 largest medical device companies worldwide. MPO has been tracking this information since 2006 and you can see their list here.
New FDA IDE guidance for early feasibility studies
By Stewart Eisenhart, Emergo Group
All Class I devices now exempt from Korea GMP requirements
By Stewart Eisenhart, Emergo Group
The Korean Ministry of Food and Drug Safety (MFDS) has exempted (link in Korean) all Class I low-risk medical devices from quality system requirements previously necessary to obtain market authorization in South Korea.
Health Canada switching to electronic delivery of medical device licenses
By Stewart Eisenhart, Emergo Group
Canadian medical device market regulator Health Canada plans to issue only electronic versions of new and amended Medical Device Establishment Licenses (MDEL) and Medical Device Licenses (MDL) starting November 1, 2013.
According to an email from Health Canada’s Medical Devices Bureau, no more hard copies of new or amended licenses will be sent out to medical device manufacturers in order to boost process efficiencies at the regulator.
U.S. government shutdown to impact FDA medical device registrations
By Stewart Eisenhart, Emergo Group
An indefinite shutdown of the US government due to an effort by the House of Representatives to stymie healthcare reform laws has caused the Food and Drug Administration to severely limit its activities related to new medical device registrations.