Postmarketing Safety Reporting for Combination Products
Posts published in July 2019
Contingency legislation covering regulation of medicines and medical devices in a no deal scenario – Human Medicines and Medical Devices (Amendment etc.) (EU exit) Regulations…
Metal Expandable Biliary Stents – Premarket Notification (510(k)) Submissions
European implementation of Medical Device and IVD Regulations – Implications for Australia
Single-use medical devices – safety and performance requirements for reprocessing
Advertising health products: Rules about safety claims in advertising
TGA presentation: Digital Devices Webinar 3, 20 June 2019
Drug and medical device highlights 2018: Helping you maintain and improve your health
FDA Recognizes AAMI Standard and TIR
Candidate List of substances of very high concern for Authorisation