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:
Emerging Markets
ANVISA extends deadline for technical requirement responses in Brazil
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.
Peruvian regulators place new requirements on medical devices with PVC components
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).
India to create medical device regulatory body
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 […]
Innovation in Medtech: harnessing “big data”
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 […]
US FDA proposes changes to MedWatch program for healthcare products
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.
Thinking about entering Middle East medical device markets? Avoid these 3 common mistakes made by ‘westerners’
By Emad Elmasry, Emergo Group In my 25+ year career working with multinational device companies, I have worked with a lot of American and European executives. The vast majority are smart and well intentioned. But time after time, companies new to the Middle East market make the same mistakes. Often, those mistakes are deeply rooted […]
Saudi regulators issue new guidance on investigational medical devices
By Stewart Eisenhart, Emergo Group The Saudi Food & Drug Authority (SFDA), the Kingdom of Saudi Arabia’s medical device market regulator, has published new guidance on requirements for conducting clinical investigations in the country. According to the guidance, all clinical investigations planned to take place in the KSA must obtain SFDA approval; all investigational medical devices […]
Report: Medtronic looks longingly at China
Substantial medical device review fee increases at Taiwan Food and Drug Administration
By Stewart Eisenhart, Emergo Group
Taiwan’s medical device market regulator has published significant new fee increases for various aspects of their device review and approval process. The increases are set to take effect July 1, 2015.
Seven mistakes that can delay your FDA 510(k) clearance
By Stewart Eisenhart, Emergo Group
Based on data provided by the US Food and Drug Administration as well as Emergo consultants’ experience with medical device manufacturing clients seeking US marketing approval, seven major issues have been identified as the most common perennial causes for delayed premarket notification applications.