By Stewart Eisenhart, Emergo Group
DIGEMID, Peru’s medical device regulatory agency, has identified more than 400 products that do not require registration as medical devices in the country.
The Medical Device Business Journal — Medical Device News & Articles | MassDevice
By Stewart Eisenhart, Emergo Group
DIGEMID, Peru’s medical device regulatory agency, has identified more than 400 products that do not require registration as medical devices in the country.
By Stewart Eisenhart, Emergo Group
Russian medical device market regulator Roszdravnadzor has begun providing updates that suggest greater alignment and harmonization with other countries’ rules and requirements. So far no concrete proposals have emerged, however.
By Stewart Eisenhart, Emergo Group
Medical device market regulators in Russia have begun developing guidelines (link in Russian) for evaluating quality, safety and effectiveness of in vitro diagnostic (IVD) devices.
Roszdravnadzor officials have started consultations with industry and academic sources in order to draw up uniform standards for IVD product reviews.
Four patients in Kuala Lumpur, Malaysia were successfully treated with CardioKinetix’s catheter-based Parachute ventricular partitioning device, the Menlo Park, Calif.-based firm announced late last month.
By Ingrid Mezo
By Stewart Eisenhart, Emergo Group
Argentina’s medical device market regulator ANMAT has published its latest annual maintenance fee schedule (link in Spanish) for medical device registrations for 2012. All manufacturers with both commercialized and non-commercialized devices registered in Argentina must pay the fee.
Advance Medical had a big week, raising $20 million through a new equity financing round, nabbing all the assets of rival Brazilian distributor Imunotech Sistemas and adding a pair of medtech veterans to its team.
The Chinese Commerce Ministry’s anti-monopoly bureau is looking for information on pricing and operations at medical device makers within the country as well as from around the world, according to a Reuters report.
Local sources told the new service that concerns about local corruption and price-fixing may have spurred the survey, but a deputy director at the China Assn. for Medial Devices Industry told reporters that there hadn’t been word of any official investigations into the sector.
By Stewart Eisenhart, Emergo Group
Argentina’s medical device market regulator ANMAT has published its latest annual maintenance fee schedule (link in Spanish) for medical device registrations for 2012.
All manufacturers with both commercialized and non-commercialized devices registered in Argentina must pay the fee.