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South Africa: Renewal of Medicines Certificate of Registration Framework

On 26th August, 2025 the South African Health Products Regulatory Authority (SAHPRA) has introduced a structured framework for the...

Sharan Murugan

1 day ago2 min read

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

7 days ago2 min read

SAHPRA’s Biological Medicines Amendment Guideline - A Critical Update for Biologic Product Sponsors

The South African Health Products Regulatory Authority (SAHPRA) has released the sixth version of its Biological Medicines Amendment...

Sharan Murugan

Jun 72 min read

South Africa SAHPRA's Med Dev Guidance: Updated Q&A-Guide to Licensing Medical Device Establishments

In South Africa, the licensing of medical device establishments is a vital step to ensure compliance with national health regulations and...

Sharan Murugan

May 242 min read

SAHPRA Guideline: Section 21 Access to Unregistered Medicines

The South African Health Products Regulatory Authority (SAHPRA) has updated its Guideline " Section 21 Access to Unregistered Medicines "...

Sharan Murugan

Apr 63 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 162 min read

SAHPRA South Africa: Guideline for Classification of Medical Devices and In Vitro Diagnostics (IVDs)

The South African Health Products Regulatory Authority (SAHPRA) has released an updated " Guideline for the Classification of Medical...

Sharan Murugan

Mar 12 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 192 min read

South Africa's SAHPRA: Renewal Process for Human -A Comprehensive Guide

The South African Health Products Regulatory Authority (SAHPRA) is responsible for monitoring, evaluating, and regulating the renewal of...

Sharan Murugan

Feb 122 min read

South Africs's SAHPRA Guidance: on Medical Device Adverse Event Reporting

The South African Health Products Regulatory Authority (SAHPRA) has issued comprehensive guidelines to streamline the reporting of...

Sharan Murugan

Jan 263 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 262 min read

SAHPRA's: Guidelines for Medical Device Adverse Event Reporting

The South African Health Products Regulatory Authority (SAHPRA) has released two crucial guidelines to streamline adverse event reporting...

Sharan Murugan

Dec 15, 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

South Africa-SAHPRA: Engagement Portal

As part of the South African Health Product Regulatory Authority’s (SAHPRA) Digitalisation Project, we launched the SAHPRA Engagement...

Sharan Murugan

Nov 9, 20242 min read

SAPHRA News: Implementation of RIMS – Information on eCTD 3.1 Module 1

The South African Health Products Regulatory Authority (SAHPRA) has released a communication " Implementation of RIMS – Information on...

Sharan Murugan

Oct 27, 20242 min read

South Africa SAHPRA: eCTD Validation and Technical Screening for Renewals - Template

The South African Health Products Regulatory Authority (SAHPRA) has provided updated guidance for " ECTD Validation And Technical...

Sharan Murugan

Sep 9, 20242 min read

SAPHRA Guidance: Guideline On Co-Applicancy

The South African Health Products Regulatory Authority (SAHPRA) has released a comprehensive "Guideline on Co-applicancy". This guidance...

Sharan Murugan

Jul 20, 20241 min read

South Africa (SAPHRA): Reliance Guideline

Recently this week the South African Health Products Regulatory Authority (SAHPRA) has updated the Reliance Guideline to streamline the...

Sharan Murugan

May 18, 20242 min read

South Africa SAPHRA: Guideline For Professional Information For Human Medicines (Categories A and D) and Classification of Medical Devices and IVDs

Recently last week the South African Health Products Regulatory Authority (SAPHRA) released an updated "Guideline For Professional...

Sharan Murugan

Mar 30, 20242 min read

South Africe SAPHRA: Guidelines For Medicine Recalls – Withdrawals And Rapid Alerts

Recently last week the South African Health Products Regulatory Authority (SAPHRA) released an updated guideline "Guidelines For Medicine...

Sharan Murugan

Feb 22, 20242 min read