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...
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AdvaMed is asking Health Canada to revise its draft guidance on preparing license applications for implantable medical devices that are produced using additive manufacturing...
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...
FDA to Test PreCert De Novo Requests Under Pilot

USA – FDA to Test PreCert De Novo Requests Under Pilot

The US Food and Drug Administration (FDA) issued a three-part update Monday on its Pre-Certification (PreCert) pilot program for digital health developers, detailing how...
FDA Looks to Improve UDI Data Quality With Relaxed Limits on Labelers’ Corrections

USA – FDA Looks to Improve UDI Data Quality With Relaxed Limits on Labelers’...

A recent US Food and Drug Administration (FDA) notice proposed reverting to a 7-day grace period to review, edit and correct records that medical...
TGA Pushes for Total Product Lifecycle Approach to Medical Device Cybersecurity

Australia – TGA Pushes for Total Product Lifecycle Approach to Medical Device Cybersecurity

New draft guidance from Australia’s Therapeutic Goods Administration (TGA) encouraged use of regulatory policies that span total product lifecycles (TPLC) to ensure medical device...
MDUFA Report Touts CDRH Efforts to Improve Medical Device Review Processes

USA – MDUFA Report Touts CDRH Efforts to Improve Medical Device Review Processes

Efforts at the US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) to improve the medical device review process under the Medical...
What Will 2019 Bring for Medtech?

USA – What Will 2019 Bring for Medtech?

Healthcare is definitely changing, evident from several developments in 2018. While payers and providers have been working for some time to improve healthcare quality...

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