By Stewart Eisenhart, Emergo Group
The German government has formed a committee of industry and regulatory experts charged with developing a national innovation policy for medical technology.
The Medical Device Business Journal — Medical Device News & Articles | MassDevice
By Stewart Eisenhart, Emergo Group
The German government has formed a committee of industry and regulatory experts charged with developing a national innovation policy for medical technology.
By Stewart Eisenhart, Emergo Group
Dr. V. G. Somani has been named Drug Controller General of India (DCGI) as of October 31, 2011. India’s Ministry of Health and Welfare has appointed him to the position overseeing the country’s medical device market for a three-month period, or until further notice.
By Stewart Eisenhart, Emergo Group
Following recent meeting of India’s Drug Technical Advisory Board and Drug Consultative Committee, proposals to expand the list of Notified medical devices requiring registration have emerged.
By Stewart Eisenhart, Emergo Group
Mexican medical device regulator COFEPRIS plans to establish a new device category, Class 1A, for nearly 100 products currently exempt from registration requirements.
Items on the list include tongue depressors, nasal aspirators, umbilical tapes and clamps, gauze, compression bandage systems and bandages.
By Stewart Eisenhart, Emergo Group
The US Food and Drug Administration has published draft guidance establishing two pathways for medical device manufacturers filing de novo petitions to reclassify their devices from Class III to Class I or II.
By Stewart Eisenhart, Emergo Group
A voluntary code of conduct for European Notified Bodies appears to be gaining traction following the document’s publishing in early 2011.
Medtechinsider.com reports that eleven Notified Bodies have now signed the code of conduct ahead of a highly anticipated recast of the European Medical Devices Directive.
By Stewart Eisenhart, Emergo Group
Canadian medical technology industry trade group MEDEC has found both decreasing volumes of applications sent to Health Canada’s Medical Devices Bureau (MDB) in the second quarter of 2011 as well as delayed market authorizations for the bulk of submitted applications due to recent regulatory changes.
By Stewart Eisenhart, Emergo Group
Canadian medical device market regulator Health Canada will begin requiring manufacturers and importers to send Mandatory Problem Reports (MPRs) to its Health Canada Vigilance-Medical Device Program Reporting Program (CVMD), beginning October 3, 2011.
By Stewart Eisenhart, Emergo Group
New Manufacturer Evaluation Codes for use in medical device reports have been established by the US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH).
Developed by the CDRH in collaboration with the National Cancer Institute Enterprise Vocabulary Service, the new codes update those used in Section H6 of FDA Form 3500A, and pertain to evaluation methods, results and conclusions of device evaluations.
By Stewart Eisenhart, Emergo Group
Saudi Arabia’s Medical Device Interim Regulation (MDIR), which includes new documentation requirements for foreign manufacturers importing to the Saudi market, have gone into effect.
By Stewart Eisenhart, Emergo Group
New guidance from the US Food and Drug Administration recommends adoption of more risk-based methods by sponsors to monitor clinical investigations including investigational device exemptions (IDEs) and Investigational New Drugs (INDs).