URGENT/11 medical device cyber vulnerabilities prompt risk mitigation recommendations from US FDA

New European MDCG guidance addresses SSCP requirements

New ANVISA regulations for custom-made and patient-specific medical devices

“Navigate your way through the regulatory grey.” That was the tagline for the 2019 Regulatory...

Latest FDA approaches to oversight of mobile medical apps and digital health products considered medical devices

Germany’s TÜV Rheinland has received designation to issue CE Mark certificates under the European Medical...

Accreditation Scheme for Conformity Assessment (ASCA) pilot takes shape

How the UK REP role may affect UK market access following a no-deal Brexit

Final guidance for alternate FDA 510(k) market authorization routes, plus updated Refuse to Accept policy

EC sets parameters of expert panel component of MDR, IVDR

Cosmetic products will need CE Marking to be commercialized in Europe

Cybersecurity compliance questions medical device manufacturers should be asking

For healthcare product and medical device technology developers, ensuring effective support for cybersecurity compliance is...

New regulatory system, MDMA application fees and deadlines for Saudi Arabia market registrants

COFEPRIS to accept online import permit requests only starting in late September 2019