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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 232 min read
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SAHPRA Regulatory Information Management System (RIMS): Cancellation of Health Product Registrations for Non-eCTDs
The South African Health Products Regulatory Authority (SAHPRA)Â has issued a Communication to the industry " Regulatory Information...
Sharan Murugan
Mar 162 min read
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SAHPRA South Africa: Renewal of the Certificate of Registration - Fee Schedule and Explanatory Notes
The South African Health Products Regulatory Authority (SAHPRA)Â has updated its " Fee Schedule and Explanatory Notes " Â to renew human...
Sharan Murugan
Feb 192 min read
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South Africs's SAHPRA Communication: Regulatory Information Management System – Application Withdrawal
The South African Health Products Regulatory Authority (SAHPRA)Â has issued a Communication to the industry on the process for the...
Sharan Murugan
Jan 262 min read
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USFDA Guidance: Enhancing Communication and Guidance Development Practices
The US Food and Drug Administration (USFDA) Â has released two insightful reports aimed at improving its internal practices and...
Sharan Murugan
Dec 4, 20242 min read
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