Sahpra

Sahpra Contact information, map and directions, contact form, opening hours, services, ratings, photos, videos and announcements from Sahpra, Medical and health, Building A, Loftus Park, 402 Kirkness Street, Arcadia, Pretoria.

SAHPRA is an entity of the National Department of Health, created by the South African Government to ensure that the health and well-being of human and animal health is at its core.

📢 Invitation to Industry StakeholdersThe South African Health Products Regulatory Authority (SAHPRA) invites industry st...
14/04/2026

📢 Invitation to Industry Stakeholders

The South African Health Products Regulatory Authority (SAHPRA) invites industry stakeholders to a targeted stakeholder engagement session focused on training and guidance on Adverse Event reporting requirements.

This engagement aims to strengthen understanding and implementation of Regulation 17 of the Regulations Relating to Medical Devices, including In Vitro Diagnostic Medical Devices (IVDs). The session supports regulatory compliance, enhances post‑market surveillance, and promotes the safety, performance, and quality of medical devices in South Africa.

🔍 Key focus areas include:
• Identification, assessment, and reporting of adverse events and near‑adverse events
• Clarification of legal obligations and reporting timelines
• Guidance on submission processes and applicable regulatory guidelines

This session is essential for stakeholders involved in the lifecycle of medical devices within the South African market.

📌 Stay engaged. Stay compliant. Strengthen patient safety.

Register here: https://bit.ly/4tcSUK6

📣 Calling All Healthcare Professionals Who Administer Vaccines!Do you administer vaccines as part of your daily work? Th...
12/04/2026

📣 Calling All Healthcare Professionals Who Administer Vaccines!

Do you administer vaccines as part of your daily work? This Webinar is for you!

The South African Health Products Authority (SAHPRA) will be hosting two important webinars on Adverse Events Following Immunisation (AEFI) reporting and the launch of the VigiMobile App for Healthcare Professionals.
🗓 Dates:
• Thursday, 16 April
• Monday, 20 April
🕑 Time: 14:00 – 15:00

AEFI surveillance is a vital component of South Africa’s Expanded Programme on Immunisation (EPI) and relies on timely, accurate reporting by healthcare professionals.

To strengthen reporting, SAHPRA—together with the National Department of Health—has introduced electronic submission of AEFI reports.

This webinar will help you:
✅ Understand basic AEFI concepts
✅ Appreciate the importance of reporting both serious and non-serious AEFIs
✅ Learn how to submit AEFI reports using the VigiMobile App

🔔 Webinar topics include:
• Understanding basic concepts and reporting of AEFIs
• Live demonstration of AEFI reporting using VigiMobile

👉 Register now:
🔗 First Webinar (16 April): https://bit.ly/427vCJn
🔗 Second Webinar (20 April): https://bit.ly/47V7RYD

We look forward to your participation!

11/04/2026

🔔 Important Notice: ISO 13485 Requirement – Phase 3

The Medical Device Unit advises all Manufacturers and Distributors (Importers) that Phase 3 of the ISO 13485 certification requirement is now in effect.

✅ Existing licence holders are encouraged to voluntarily submit a valid ISO 13485:2016 (or later) certificate issued by a recognised conformity assessment body.
📧 Submissions may be sent to mdqueries@sahpra.org.za.

🔗 For more information, visit:
https://www.sahpra.org.za/document/iso-13485-certificate-as-a-prerequisite-for-the-approval-of-a-medical-device-establishment-licence/

Thank you for your continued cooperation.

02/04/2026

📢 SAHPRA Vacancy Alert!

The South African Health Products Regulatory Authority (SAHPRA) invites applications for the position of:

Quality Management System Practitioner
(Fixed-term contract until March 2028)

Contribute to strengthening quality systems that support the regulation of safe, effective and high-quality health products in South Africa.

🔗 Find out more and apply: https://bit.ly/41uX9Uk

02/04/2026

📢 SAHPRA Vacancy Alert!

The South African Health Products Regulatory Authority (SAHPRA) invites suitably qualified candidates to apply for the position of:

Manager: Clinical Pre-Registration Evaluations

Play a key role in ensuring the safety, quality and efficacy of health products before they reach the public.

🔗 Find out more and apply: https://bit.ly/41uX9Uk

✅ Clarity and Awareness about the Findings on the Sanitary Pads Study Conducted by the University of Free State ❓️ Do Sa...
28/03/2026

✅ Clarity and Awareness about the Findings on the Sanitary Pads Study Conducted by the University of Free State

❓️ Do Sanitary Pads Cause Hormonal or Other Health Concerns?

There is no scientific evidence linking the trace EDCs found in sanitary pads or panty‑liners to hormonal disruption, cancer, infertility, endometriosis, or any other health conditions.
Detecting a substance does not mean it is harmful — especially when present at very low concentrations. SAHPRA and global regulators continue to monitor new evidence to ensure ongoing public safety.

🔗 Learn more here: https://bit.ly/4bP2zPx

27/03/2026

📢 SAHPRA Vacancy Alert!

The South African Health Products Regulatory Authority (SAHPRA) invites applications for the position of:

Technical Officer: Medical Devices Registration

🗓 Closing date: 10 April 2026

Be part of an organisation dedicated to ensuring the safety, quality and efficacy of medical devices in South Africa.

🔗 Find out more and apply: https://bit.ly/41uX9Uk

📢 What should you do if you have already consumed the affected products?If you have already used any of the affected Cit...
27/03/2026

📢 What should you do if you have already consumed the affected products?

If you have already used any of the affected Citro‑Soda batches and are experiencing side effects, please consult your doctor or nearest health facility immediately. You are also encouraged to report your experience to SAHPRA so that any potential health risks can be managed effectively.

📮 Report side effects to SAHPRA:
✉️ adr@sahpra.org.za
🌐 https://medsafety.sahpra.org.za
🌐 https://vigiflow-eforms.who-umc.org/za/ereporting

🔎 List of affected batches: https://bit.ly/3PkaRr7

27/03/2026

📢 What should consumers do if they have bought these products?

Consumers who have purchased any of the affected Citro‑Soda batches are advised to return the products to the store or pharmacy where they bought them for an exchange or refund. SAHPRA urges the public to cooperate to help ensure continued product safety and quality.

🔎 Full list of affected batches: https://bit.ly/3PkaRr7

📢 What should retail pharmacies, wholesalers, and distribution centres do?SAHPRA requests all retail pharmacies, wholesa...
27/03/2026

📢 What should retail pharmacies, wholesalers, and distribution centres do?

SAHPRA requests all retail pharmacies, wholesalers, and distribution centres to immediately stop selling any affected Citro‑Soda batches and return all stock to their supplying warehouse or distribution centre. This is essential to protect public safety and to ensure the recall is carried out efficiently.

🔎 Full list of affected batches: https://bit.ly/3PkaRr7

✅ Clarity and Awareness about the Findings on the Sanitary Pads Study Conducted by the University of Free State ❓️ Do Lo...
26/03/2026

✅ Clarity and Awareness about the Findings on the Sanitary Pads Study Conducted by the University of Free State

❓️ Do Low‑Risk Medical Devices Still Need Good Manufacturing Practices?

Yes. Even though sanitary pads and panty‑liners are classified as low‑risk medical devices, manufacturers are still required to follow internationally recognised manufacturing and safety standards.

This ensures that all products on the market meet strict quality, safety, and performance requirements — keeping consumers protected at all times.

🔗 Learn more here: https://bit.ly/4bP2zPx

✅ Clarity and Awareness about the Findings on the Sanitary Pads Study Conducted by the University of Free State ❓️ What ...
26/03/2026

✅ Clarity and Awareness about the Findings on the Sanitary Pads Study Conducted by the University of Free State

❓️ What Are Endocrine‑Disrupting Chemicals (EDCs)?

Endocrine‑Disrupting Chemicals (EDCs) are natural or synthetic substances found in many everyday items — including cosmetics, personal care products, plastics, and some food packaging. These substances can interact with hormones, which help regulate important body functions.
While the UFS study detected trace levels of EDCs in some sanitary pads, the levels were very low and did not pose any risk to users. Global health bodies, including the WHO, have monitored EDCs for over a century and have found no evidence of harm at these low exposure levels.

🔗 Learn more here: https://bit.ly/4bP2zPx

Address

Building A, Loftus Park, 402 Kirkness Street, Arcadia
Pretoria
0001

Opening Hours

Monday 08:00 - 15:30
Tuesday 08:00 - 15:30
Wednesday 08:00 - 15:30
Thursday 08:00 - 15:30
Friday 08:00 - 12:00

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