By Stewart Eisenhart, Emergo Group New draft guidance from the US Food and Drug Administration seeks comment on how to effectively apply requirements that Unique Device Identification data be applied directly to medical devices intended for reprocessing and reuse. The agency’s guidance points out that its UDI rule, 21 CFR 801.25, explicitly requires directing UDI marking on […]
By Stewart Eisenhart, Emergo Group Regulators in Hong Kong have published a new list of recognized standards applicable to medical devices as the region moves toward more formal oversight of its device market.
By Stewart Eisenhart, Emergo Group Brazil’s medical device market offers significant growth potential for foreign manufacturers, but the country’s device approval process is challenging. In this podcast, Emergo Vice President of Business Development Ann Marie Boullie provides an overview of Brazil’s regulatory requirements for medical device registration, including:
By Stewart Eisenhart, Emergo Group In an effort to boost predictability and transparency of its Investigational Device Exemption (IDE) review process, the US Food and Drug Administration has published new guidance explaining key issues the agency uses to assess benefits and risks of IDE submissions for clinical investigations of Class III and some Class II […]
By Stewart Eisenhart, Emergo Group New rules issued by medical device market regulators in the Kingdom of Saudi Arabia require new barcodes for some types of devices registered for sale in the KSA.
By Stewart Eisenhart, Emergo Group Medical device manufacturers thinking about market authorization pathways in Canada can learn more about the process via this Emergo podcast. Emergo Managing Director for Canada Daryl Wisdahl explains key issues related to Canadian regulatory requirements for medical devices, including:
By Stewart Eisenhart, Emergo Group Brazilian medical device market regulator ANVISA has officially extended deadlines for market applicants to respond to technical inquiries regarding their registration submissions.
By Stewart Eisenhart, Emergo Group DIGEMID, Peru’s medical device market regulatory agency, has rolled out new disclosure and laeling rules for medical devices that contain polyvinyl chloride (PVC) or PVC that contains DEHP (di-(2-ethylhexyl)phthalate).
The Indian Department of Pharmaceuticals is slated to create a new regulatory body to oversee pricing and promotion of medical devices in India, the Times of India reports. The proposal was made in a draft, titled the “National Medical Device Policy 2015”, from India’s DOP, which stated a major focus for the department will be on […]
Big data – from electronic health records, bio-feedback from wearables and remote monitoring systems that communicate with medical implants – is changing how medical devices are created and designed. MassDevice.com spoke to a pair of researchers at Battelle – David Giles, senior director of medical devices and health analytics and Stephanie Kute, platform lead for the […]
By Stewart Eisenhart, Emergo Group US drug and medical device market regulators are proposing changes to voluntary and mandatory post-market reporting forms used by consumers and healthcare providers for adverse events related to medical products.