Brexit: 10 key changes to UK product safety laws?

UK – Brexit: 10 key changes to UK product safety laws?

Given developments this week, Brexit remains top of the agenda.  While the UK government doesn't have the same level of "shut down" as the...
Impact of the USMCA on the Medical Device Industry

USA – Impact of the USMCA on the Medical Device Industry

Since the inception of the North American Free Trade Agreement (NAFTA), trade in medical products expanded nearly 760 percent with 16.5 billion dollars made...
Canada Completes Transition to MDSAP

Canada – Canada Completes Transition to MDSAP

Most companies in the Canada market were able to meet the 1 January deadline to complete the transition into the Medical Device Single Audit...
Prothèses capillaires et accessoires (HAS)

France – Prothèses capillaires et accessoires (HAS)

Un avis de projet a été publié au Journal Officiel en date du 10 août 2018 sur la modification des modalités de prise en...
Abbott Snags FDA Approval for Neonatal Heart Device

USA – Abbott Snags FDA Approval for Neonatal Heart Device

Abbott obtained US Food and Drug Administration (FDA) approval for its pea-sized Amplatzer Piccolo Occluder. This is the first medical device in the world to...
Kheiron Medical launches trial of AI algorithm for breast cancer Dx

Europe – Kheiron Medical launches trial of AI algorithm for breast cancer Dx

Several European companies have trained artificial intelligence to detect signs of breast cancer, in the hope that a breakthrough will help hospitals contending with...
AdvaMed Calls for Revisions to Health Canada Guidance on 3D-Printed Implantable Devices

Canada – AdvaMed Calls for Revisions to Health Canada Guidance on 3D-Printed Implantable Devices

AdvaMed is asking Health Canada to revise its draft guidance on preparing license applications for implantable medical devices that are produced using additive manufacturing...
China’s NMPA Launches Voluntary Device Master File Process

China – China’s NMPA Launches Voluntary Device Master File Process

Chinese regulators are launching a record filing process for medical device master files (DMFs). DMFs are used by NMPA reviewers and Chinese market...
Wearable dialysis system gains breakthrough designation from FDA

USA – Wearable dialysis system gains breakthrough designation from FDA

AWAK Technologies recently announced the FDA has granted breakthrough device designation to its wearable PD system that incorporates AWAK’s sorbent technology. According to a company...
Seizure Monitoring Smartwatch Cleared for Use in Children

USA – Seizure Monitoring Smartwatch Cleared for Use in Children

The Food and Drug Administration (FDA) has granted 501(k) clearance to the Embrace watch for use in epilepsy patients aged ≥6 years. The smartwatch...

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