International – MDSAP policy for remote quality system audits to expire in September 2022
Medical device market regulators participating in the Medical Device Single Audit Program (MDSAP) plan to end COVID-19-era policies allowing remote audits of quality management...
USA – FDA takes a step forward for machine learning with quantitative imaging guidance
The US Food and Drug Administration finalized guidance on what to consider when using quantitative imaging algorithms in radiological device submissions. While most imaging...
New Zealand – Guideline on the Regulation of Therapeutic Products in New Zealand
Pharmacovigilance is defined by the WHO as the science and activities relating to the
detection, assessment, understanding and prevention of adverse events or any medicinerelated...
India – India issues new draft IVD rules and updated classifications for rehab devices
Indian medical device market regulators have published new draft in vitro diagnostic device rules and made them available for industry comment. In addition, Indian...
China – Un robot miniature biodégradable pour l’administration ciblée de médicaments
La libération ciblée de médicaments aux emplacements souhaités est difficile dans le tractus gastro-intestinal en raison de l'environnement acide/alcalin de l'estomac et des intestins,...
USA – FDA official says pandemic reauthorization bill could drive VALID across finish line
A top US Food and Drug Administration (FDA) official said that a pandemic funding reauthorization bill could act as a vehicle for in vitro...
France – Implants Essure® : l’étain mis en cause dans la toxicité du dispositif
Mis sur le marché en 2002 et retirés en 2017, les implants Essure® étaient proposés aux femmes de plus de 45 ans ayant déjà...
UK – Extension of CE certificates
The EU has taken steps to give manufacturers more time to get certain medical devices certified under the EU Medical Devices Regulation (EU MDR). The new...
Europe – 38ème organisme notifié au titre du Règlement 2017/745
38ème organisme notifié au titre du Règlement 2017/745
USA – FDA drafts guidance on device production and quality system software assurance
The US Food and Drug Administration (FDA) has issued a draft guidance on software assurance for computer and data processing systems associated with medical...
