Medical Devices Archives

10 Apr SAHPRA’s Medical Devices’ Registration Update – Upcoming Feasibility Study

Posted at 15:48h in

The Medical Devices Unit of the South African Health Products Regulatory Authority (SAHPRA) hosted an awareness session on this unit’s medical device registration update on the upcoming voluntary feasibility study. Date: 19 April 2024 Time: 10:00 to 13:00 Download Presentation Download Feasibility Study Watch Recording: ...

19 Mar Virtual Meeting | Conformity Assessment Bodies Meeting

Posted at 08:57h in

The South African Health Products Regulatory Authority (SAHPRA), in collaboration with the South African National Accreditation System (SANAS), hosted a Conformity Assessment Bodies (CABs) Virtual Meeting. What was discussed? Extension of scope of practice to include technical dossier review SANAS Accreditation process SAHPRA requirements and future process Who...

29 Jun Medical Devices Stakeholder engagement Industry Meeting

Posted at 11:31h in

A Consultative meeting with the industry to communicate updates, and improve the application process, as well as the overall services and relations. Date: 28 June 2023 Time: 9h00 to 12h30 Watch Recording ...

04 Jan Register for an Africa Continental Good Regulatory Practice Workshop

Posted at 10:17h in News & Updates

The US Agency for International Development (USAID), the American National Standards Institute (ANSI), and Advanced Medical Technology Association (AdvaMed) is hosting a Workshop on Good Regulatory Practices and its implementation in the Medical Device Sector on 31 January and 01 February 2023. To register, click here. Read...

Bru-nO via Pixabay

04 Nov SAHPRA is investigating Tembisa Hospital procurement of health products

Posted at 09:19h in News & Updates, Press Releases

Pretoria, 4 November 2022 – The South African Health Products Regulatory Authority (SAHPRA) takes note of the alleged procurement of hospital consumables and medical devices in breach of the Medicines and Related Substances Act (Act 101 of 1965, as amended). SAHPRA is currently investigating the matter....

10 Aug Webinar – Good Regulatory Practices and its implementation in the Medical Devices Sector

Posted at 15:38h in

We are pleased to invite you to participate in an online webinar on “Good Regulatory Practices and its implementation in the Medical Devices Sector” that will take place on 10 and 11 August 2022 under the joint work of the COVID-19 Medical Device Regulatory Convergence...

06 Aug SAHPRA educates, informs during SAAPI Conference 2022

Posted at 12:00h in News & Updates

Johannesburg, 06 August 2022 - The South African Health Products Regulatory Authority (SAHPRA) was invited to speak at this year’s South African Association of Pharmacists in Industry (SAAPI) Conference during 03-05 August 2022 sharing vital information across core functional areas of the organisation. SAHPRA was...

05 Jun Section 21 extension (Ventilators – invasive and non-invasive)

Posted at 10:21h in News & Updates

07 June 2021 To whom it may concern We draw your attention to the provisions of Section 21 of the Medicine and Related Substances Act, 1965 (Act 101 of 1965), to authorise the sale of unregistered medicines or medical devices for certain purposes. The communication...

Medical Devices Tag

10 Apr SAHPRA’s Medical Devices’ Registration Update – Upcoming Feasibility Study

19 Mar Virtual Meeting | Conformity Assessment Bodies Meeting

29 Jun Medical Devices Stakeholder engagement Industry Meeting

04 Jan Register for an Africa Continental Good Regulatory Practice Workshop

04 Nov SAHPRA is investigating Tembisa Hospital procurement of health products

10 Aug Webinar – Good Regulatory Practices and its implementation in the Medical Devices Sector

06 Aug SAHPRA educates, informs during SAAPI Conference 2022

05 Jun Section 21 extension (Ventilators – invasive and non-invasive)

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