By Stewart Eisenhart, Emergo Group
Federal budget negotiations currently underway in the U.S. Congress would rescind a controversial tax on medical device sales in the country.
The Medical Device Business Journal — Medical Device News & Articles | MassDevice
By Stewart Eisenhart, Emergo Group
Federal budget negotiations currently underway in the U.S. Congress would rescind a controversial tax on medical device sales in the country.
By Stewart Eisenhart, Emergo Group
A new report commissioned by the US Food and Drug Administration identifies four broad areas where the regulator should improve its methods for clearing or approving medical devices for sale.
By Stewart Eisenhart, Emergo Group
Canadian medical device market regulators have provided more details about their participation in the international Medical Device Single Audit Program (MDSAP) pilot set to begin in 2014 in Canada, the US, Brazil and Australia.
By Stewart Eisenhart, Emergo Group
Colombian medical device market regulator INVIMA has set a deadline of August 11, 2014 for registration of more than 30 types of medical devices previously exempt from market authorization requirements.
By Stewart Eisenhart, Emergo Group
Canadian medical device market regulators have begun making some information on medical device clinical trials available upon request in an effort to boost public access to such data.
Health Canada’s new policy entails sharing information including:
By Stewart Eisenhart, Emergo Group
Legal reforms affecting medical device regulation in Japan have passed the country’s Diet and are now published in the official Japanese gazette, bringing them closer to full enactment in Asia’s largest single medical device market.
By Stewart Eisenhart, Emergo Group
New laws set to take effect in Argentina will require medical device manufacturers and importers to provide Installation, Maintenance and Service Manuals for their products only in Spanish to regulatory authority ANMAT, according to Emergo Group’s Buenos Aires office.
By Stewart Eisenhart, Emergo Group
The US Food and Drug Administration has published draft technical specifications related to its Unique Device Identification (UDI) rule finalized earlier this year.
By Stewart Eisenhart, Emergo Group
ANVISA, Brazil’s medical device market regulator, has issued a new public consultation (link in Portuguese) proposing eased Brazilian Good Manufacturing Practice (BGMP) requirements for medical device manufacturers submitting their products for registration.
By Stewart Eisenhart, Emergo Group
Medical device market regulators in Australia and New Zealand have implemented a series of projects involving adverse event notification, device recall information and quality system inspections as part of the countries’ long-term effort to establish a single regulatory agency, the Australia New Zealand Therapeutic Products Agency (ANZTPA).
By Stewart Eisenhart, Emergo Group
Regulators in Ukraine will implement significant reforms to the country’s medical device registration system in early 2014 in order to better align market authorization requirements with those of the European Union, Emergo Group has learned.
The new system will utilize national conformity assessments similar to those used by EU regulators, and also introduces the following requirements for Ukrainian medical device registrations: