By Stewart Eisenhart, Emergo Group
Health Canada has published new guidance for manufacturers of Class II, III and IV medical devices on the Medical Device License renewal process.
The Medical Device Business Journal — Medical Device News & Articles | MassDevice
By Stewart Eisenhart, Emergo Group
Health Canada has published new guidance for manufacturers of Class II, III and IV medical devices on the Medical Device License renewal process.
By Stewart Eisenhart, Emergo Group
Drugs Control General of India (DCG(I)), the country’s regulatory agency overseeing medical devices and pharmaceuticals, is currently lacking a director, stalling all product approvals until the director’s reappointment.
Reflexonic LLC landed FDA clearance for the first hand-held, non-pharmaceutical device intended to help men with moderate erectile dysfunction, poor maintenance and rigidity or spinal cord injuries achieve successful erection and ejaculation at home.
Viberect is the only device in the world that delivers targeted vibration applied to the top and bottom of the penis using medical pads that stimulate the pudendal and dorsal nerves.
The tool is indicated for use prior to sexual activity and claims to amplify subsequent orgasm and ejaculation.
By Stewart Eisenhart, Emergo Group
Mexican medical device regulators plan to establish simplified registration for in vitro diagnostics and other low-risk products, and to exempt another 1,700 health products from medical device registration requirements altogether in an effort to increase market competition, improve public health and boost job creation.
By Stewart Eisenhart, Emergo Group
Health Canada has provided recommendations for medical device manufacturers whose products must comply with the latest iteration (Third Edition) of the IEC 60601-1 medical electrical equipment safety standards.
Medical device makers down under are concerned about a government plan to create a new joint regulatory agency for medical devices in Australia and New Zealand.
This week, the governments announced a five year plan to create the Australia New Zealand Therapeutic Products Agency (ANZTPA), which will regulate medicines, medical devices and new medical interventions.
MASSDEVICE ON CALL — Medical device consulting firm Emergo Group released results from a study of the U.S. Food & Drug Administration’s medical device application review, finding that application times jumped 37 percent from 2006 to 2010.
Emergo reviewed the number of submissions the FDA clears each year and how long it takes to win 510(k) clearance to obtain an average "submission to clearance" time.
In 2006 510(k) applications cleared by the FDA took an average of 96 days, but that number jumped to 132 days in 2010.
By Stewart Eisenhart, Emergo Group
The US FDA’s Center for Devices and Radiological Health (CDRH) and Center for Biologics Evaluation and Research (CBER) have issued a notice warning of possible effects the ongoing nuclear disaster in Japan may have on medical device components exported to the US.
By Stewart Eisenhart, Emergo Group
The US FDA’s Center for Devices and Radiological Health has released data on warning letter cites regarding manufacturers’ quality system deficiencies in 2010.
By Stewart Eisenhart, Emergo Group
Nine medical device industry associations have signed on to the Global Compliance Statement on Interactions Between Medical Technology Companies and Healthcare Professionals (HCPs), a document intended to promote ethically sound interactions between the groups’ member firms and health care providers.
By Stewart Eisenhart, Emergo Group
Brazil’s National Agency for Sanitary Surveillance (ANVISA) will purportedly begin charging inspection fees for Certificates of Good Manufacturing Practice and Quality Control (Brazil GMP) every two years rather than on an annual basis.