By Stewart Eisenhart, Emergo Group
The European Commission may extend its Transparency Directive covering pricing and reimbursement transparency of medicinal products to medical devices.
The Medical Device Business Journal — Medical Device News & Articles | MassDevice
By Stewart Eisenhart, Emergo Group
The European Commission may extend its Transparency Directive covering pricing and reimbursement transparency of medicinal products to medical devices.
By Stewart Eisenhart, Emergo Group
The Japan Federation of Medical Device Associations (JFMDA) has begun pushing for regulations specifically targeting the medical device industry ahead of plans next year to revise the country’s Pharmaceutical Affairs Law (PAL).
By Stewart Eisenhart, Emergo Group
European medical device industry trade group Eucomed has issued four major recommendations to the European Commission regarding easing regulatory requirements for small and medium-sized enterprises (SMEs) in order to foster innovation.
By Stewart Eisenhart, Emergo Group
The FDA’s Center for Devices and Radiological Health has issued recommendations to improve medical device import entry review processes to expedite entry of foreign-made products into the US.
By Stewart Eisenhart, Emergo Group
The Japanese government should prioritize power supply allocation to medical device manufacturing facilities producing life-saving and sustaining devices such as ventilators, oxygen supply products and defibrillators.
By Stewart Eisenhart, Emergo Group
At a Food & Drug Administration town hall meeting held March 10 in Irving, Texas, Center for Devices and Radiological Health director Dr. Jeffrey Shuren disclosed to Emergo Group officials in attendance that the agency plans to issue guidance on mobile medical applications later this year.
By Stewart Eisenhart, Emergo Group
By Stewart Eisenhart, Emergo Group
The Therapeutic Goods Administration, Australia’s medical device and pharmaceutical regulator, set up easier online access to its Australian Register of Therapeutic Goods (ARTG) database of approved products.
By Stewart Eisenhart, Emergo Group
European medical device trade association Eucomed has made adoption of technology to remotely monitor implantable cardiac devices a key element of its recently four recently submitted proposals to the European Commission Innovation Union Strategy’s Active and Healthy Ageing Innovation Partnership program.
By Stewart Eisenhart, Emergo Group
The Therapeutic Goods Administration (TGA), Australia’s medical device regulator, has specified which in vitro devices (IVDs) will be required to undergo application audits.
According to Australia’s Therapeutic Goods (Regulations) 2002, eight types of IVDs fall under the application audit requirements:
By Daniel Capuano
On Oct. 26, 2010 COFEPRIS (the Federal Commission for Protection against Sanitary Risks, of the Mexican Health Authority) officially announced the equivalence agreement to be applied to medical devices (including in-vitro diagnostics) that are commercialized in U.S. and Canada. The terms of the agreement took effect Nov. 25.