Health Canada Draft Guidance: Interpretation of Significant Change of a Medical Device

On March 18, 2024, the Center for Medical Device Evaluation (CMDE) released an important Notice...

Brazil's Draft Resolution 1200, dated September 1st, 2023, outlining a streamlined process for...

In a move aimed at bolstering the quality management of medical device operations across China, the...

On November 20, 2023, a significant development unfolded in the realm of medical device regulation...

Exciting news from the EU as the "AI Act" receives final approval, ushering in comprehensive...

Announcement on the Medical Device Administrative Management System Accepting Sales Approval from...

On February 5, 2024, the Saudi Food & Drug Authority (SFDA) marked a significant milestone with the...

The integration of AI in regulatory affairs signals a pivotal shift in the training and skill set...

In Brazil, a significant regulatory development in the realm of healthcare emerged with the...