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US FDA addresses UDI direct marking for reprocessed devices

July 1, 2015 By MassDevice Leave a Comment

By Stewart Eisenhart, Emergo Group New draft guidance from the US Food and Drug Administration seeks comment on how to effectively apply requirements that Unique Device Identification data be applied directly to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 […]

Filed Under: Blog, Emerging Markets, Regulatory/Compliance Tagged With: Emergo Group, FDA

Hong Kong regulators issue list of recognized standards for medical devices

June 30, 2015 By MassDevice Leave a Comment

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.

Filed Under: Blog, Emerging Markets, Regulatory/Compliance Tagged With: Emergo Group, FDA

Emergo Podcast: ANVISA medical device approval in Brazil

June 25, 2015 By MassDevice Leave a Comment

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:

Filed Under: Blog, Device Talks Podcasts, Emerging Markets, Regulatory/Compliance Tagged With: Emergo Group, FDA

New US FDA guidance: Six benefit-risk factors to include in medical device IDE applications

June 24, 2015 By MassDevice Leave a Comment

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 […]

Filed Under: Blog, Emerging Markets, Regulatory/Compliance Tagged With: Emergo Group, FDA

New medical device barcodes required by Saudi regulators

June 24, 2015 By MassDevice Leave a Comment

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.

Filed Under: Blog, Emerging Markets, Regulatory/Compliance Tagged With: Emergo Group, FDA

Emergo Podcast: Medical Device Licensing and Approval in Canada

June 19, 2015 By MassDevice Leave a Comment

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:

Filed Under: Blog, Device Talks Podcasts, Emerging Markets, Regulatory/Compliance Tagged With: Emergo Group, FDA

ANVISA extends deadline for technical requirement responses in Brazil

June 18, 2015 By MassDevice Leave a Comment

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.

Filed Under: Blog, Emerging Markets, Regulatory/Compliance Tagged With: Emergo Group, FDA

Peruvian regulators place new requirements on medical devices with PVC components

June 15, 2015 By MassDevice Leave a Comment

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).

Filed Under: Blog, Emerging Markets, News Well, Regulatory/Compliance Tagged With: Emergo Group, FDA

India to create medical device regulatory body

June 10, 2015 By Fink Densford Leave a Comment

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 […]

Filed Under: Emerging Markets, Legal News, Regulatory/Compliance

Innovation in Medtech: harnessing “big data”

June 9, 2015 By Fink Densford Leave a Comment

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 […]

Filed Under: Big Data, Biotech, Emerging Markets, Research & Development Tagged With: Battelle

US FDA proposes changes to MedWatch program for healthcare products

June 4, 2015 By MassDevice Leave a Comment

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.

Filed Under: Blog, Emerging Markets, News Well, Regulatory/Compliance Tagged With: Emergo Group, FDA

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