International – IMDRF guidance aims to harmonize, streamline review reports
The International Medical Device Regulators Forum (IMDRF) recently published guidance intended to streamline regulatory reporting requirements across jurisdictions. The document lays out expectations not...
International – IMDRF publishes updated guides covering governance activities and membership
The International Medical Device Regulators Forum (IMDRF) recently posted a series of updated guidelines on the group’s standard operating procedures (SOP), criteria for joining,...
International – Enfin une norme internationale sur le dosage des EEB spécifique aux DM...
La série de normes ISO 11737, qui décrit les méthodes microbiologiques associées à la stérilisation des produits de santé, se déclinera dorénavant en trois...
Saudi Arabia – Saudi FDA postpones Unique Device Identification compliance deadlines
The Saudi Food and Drug Authority (SFDA), Saudi Arabia’s medical device market regulator, has once again announced the postponement of its Unique Device Identification (UDI) requirements...
International – Diabète : un pansement intelligent pour soigner et cicatriser les plaies chroniques
Les plaies chroniques dites « non cicatrisantes » concernent des dizaines de millions de personnes dans le monde. Ainsi, de 15 % à 25 % des patients diabétiques...
International – IMDRF guidance updates thinking on personalized medical devices
The International Medical Device Regulators Forum (IMDRF) says personalized medical devices (PMD) come in three varieties that require different regulatory approaches. As certain technologies...
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...
International – Predetermined Change Control Plans for Machine Learning-Enabled Medical Devices: Guiding Principles
In 2021, the U.S. Food and Drug Administration (FDA), Health Canada, and the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) jointly identified 10...
International – E-labeling and digital transformation in healthcare
This article examines the regulations for electronic labeling (e-labeling) for prescription drugs and medical devices in Japan, Brazil, Singapore, the EU and US, Canada,...
International – IMDRF proposes legacy device cybersecurity guidance after stakeholder feedback
Communication between manufacturers and healthcare providers is key to ensuring patients with legacy medical devices are kept safe according to proposed cybersecurity guidance from...
