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...
MDR & NBs – L’inquiétude grandit (The worry is growing)

Europe – MDR & NBs – L’inquiétude grandit (The worry is growing)

Many manufacturers, healthcare professionals and other stakeholders fear that insufficient number of Notified Bodies will be designated on time enabling them to start managing...
IMDRF Gains Ground with Plans for a Medical Device Single Review Program

International – IMDRF Gains Ground with Plans for a Medical Device Single Review Program

Regulators participating in the International Medical Device Regulators Forum (IMDRF) recently convened in Tokyo to discuss a medical device single review program (MDSRP). The meeting...
Spotlight on PMCF: Requirements Ramping Up under European Medical Devices Regulation

Europe – Spotlight on PMCF: Requirements Ramping Up under European Medical Devices Regulation

The European Medical Devices Regulation (MDR) will tie post-market clinical follow-up (PMCF) data more closely to post-market surveillance and clinical evaluation report requirements. ...
TGA Plans GCP Inspection Program

Australia – Australia Explores Adopting UDI System

Device companies were given a tight deadline on Monday to comment on a new proposal that would establish a unique device identification (UDI) system...
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New draft guidance from Australia’s Therapeutic Goods Administration (TGA) encouraged use of regulatory policies that span total product lifecycles (TPLC) to ensure medical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...
Ireland's research center for medtech eyes animal testing facility

Ireland – Ireland’s research center for medtech eyes animal testing facility

Ireland’s research centre for medical devices is to consider developing a national animal testing lab, to trial medical implants on large animals. Cúram, the NUI...

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