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SAHPRA Communication: Regulatory Requirements for AI/ML-Enabled Medical Devices in South Africa
Artificial Intelligence (AI) and Machine Learning (ML) are transforming healthcare globally, offering powerful tools for diagnosis,...
Sharan Murugan
Aug 23, 20252 min read
SAHPRA Regulatory Information Management System (RIMS): Cancellation of Health Product Registrations for Non-eCTDs
The South African Health Products Regulatory Authority (SAHPRA) has issued a Communication to the industry " Regulatory Information...
Sharan Murugan
Mar 16, 20252 min read
SAHPRA South Africa: Renewal of the Certificate of Registration - Fee Schedule and Explanatory Notes
The South African Health Products Regulatory Authority (SAHPRA) has updated its " Fee Schedule and Explanatory Notes " to renew human...
Sharan Murugan
Feb 19, 20252 min read
South Africs's SAHPRA Communication: Regulatory Information Management System – Application Withdrawal
The South African Health Products Regulatory Authority (SAHPRA) has issued a Communication to the industry on the process for the...
Sharan Murugan
Jan 26, 20252 min read
USFDA Guidance: Enhancing Communication and Guidance Development Practices
The US Food and Drug Administration (USFDA) has released two insightful reports aimed at improving its internal practices and...
Sharan Murugan
Dec 4, 20242 min read
South Africa's SAHPRA: Communication to Industry on Quality Variations
The SAHPRA released a " Communication to Industry on Quality Variations " document that addresses updates on the submission requirements...
Sharan Murugan
Nov 11, 20242 min read