In August 2024, the FDA released significant guidance impacting the Medical Device De Novo submissio...
Edit Zur, a seasoned Regulatory Affairs Specialist, has been a driving force at Arazy Group for over...
Malaysia's Medical Device Authority (MDA) has just released an important regulatory update that coul...
Health Canada Draft Guidance: Interpretation of Significant Change of a Medical Device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 that...
Brazil's Draft Resolution 1200, dated September 1st, 2023, outlining a streamlined process for evalu...
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 a...
Exciting news from the EU as the "AI Act" receives final approval, ushering in comprehensive regulat...
Announcement on the Medical Device Administrative Management System Accepting Sales Approval from th...