By Stewart Eisenhart, Emergo Group
New laws setting up a formal regulatory system for medical devices have been approved by the Malaysian government, according to Med/Cert.
The Medical Device Business Journal — Medical Device News & Articles | MassDevice
By Stewart Eisenhart, Emergo Group
New laws setting up a formal regulatory system for medical devices have been approved by the Malaysian government, according to Med/Cert.
By Stewart Eisenhart, Emergo Group
In a move likely to boost interest in the Singaporean medical device market, the Health Sciences Authority (HSA), Singapore’s medical device market regulator, plans to implement new rules effective May 1 to provide expedited market access for lower-risk devices.
By Stewart Eisenhart, Emergo Group
New regulations affecting classification of vitro diagnostic (IVD) devices in Brazil will take effect in May.
By Stewart Eisenhart, Emergo Group
Health Canada has announced changes to its list of recognized list of medical device standards used to demonstrate safety, effectiveness and labeling requirements of the Canadian Medical Devices Regulations in order to foster more efficient device reviews.
By Stewart Eisenhart, Emergo Group
Indian regulators are adding staff and resources to the Central Drugs Standard Control Organization (CDSCO) in order to enforce more stringent clinical trial guidelines for medical devices and pharmaceuticals.
By Stewart Eisenhart, Emergo Group
The US Food and Drug Administration has published final guidance on its process for accepting and responding to 513(g) Requests for Information from medical device manufacturers and sponsors.
By Stewart Eisenhart, Emergo Group
The Health Sciences Authority (HSA) of Singapore and the Malaysian Ministry of Health have signed on to a memorandum of understanding in which both agencies will collaborate on regulatory science, enforcement efforts, post market vigilance and quality system issues impacting their respective markets.
By Stewart Eisenhart, Emergo Group
Brazilian medical device market regulatory ANVISA has announced tighter controls over sales of breast implants in the country following revelations of defective implants manufactured by French firm Poly Implant Prothese (PIP).
By Stewart Eisenhart, Emergo Group
Following last week’s announcement that it would implement a pilot program in June waiving FDA GMP quality system inspections for manufacturers choosing to submit recent ISO 13485:2003 audit reports, the US Food and Drug Administration has published additional explanations of how its new program will work.
By Stewart Eisenhart, Emergo Group
Canadian medical device regulator Health Canada plans to increase its fees to manufacturers starting April 1, Emergo Group’s Canada office has learned.
For Class II medical device license application reviews, fees will increase from $350 to $357.
For Class III medical device license application reviews, HC plans the following increases:
By Stewart Eisenhart, Emergo Group