Medical Devices Archives - Page 4 of 12

27 Jan Notification of an Update to the Product List(s) of a Medical Device Establishment Licence

Posted at 14:19h in

1.1 On 01 June 2017, the President of the Republic of South Africa signed into effect Amendment Act 72 of 2008 (and effectively therefore also Amendment Act 14 of 2015), which broadened the regulatory scope of the Medicines and Related Substances Act, 1965 (Act 101...

27 Jan Amendment of a Medical Device Establishment Licence

Posted at 11:54h in

On 01 June 2017, the President of the Republic of South Africa signed into effect Amendment Act 72 of 2008 (and effectively therefore also Amendment Act 14 of 2015), which broadened the regulatory scope of the Medicines and Related Substances Act, 1965 (Act 101...

18 Nov Core Business Escalation Procedure

Posted at 10:18h in

This document intends to provide clarity on SAHPRA’s Core Business Escalation procedure, to enable effective and efficient communication between SAHPRA and its stakeholders....

09 Sep Application for Clinical Investigation of Medical Devices

Posted at 10:44h in

09 Sep Post Market Surveillance and Post-market Clinical Follow-up Studies

Posted at 10:34h in

This guideline is intended to provide recommendations to Manufacturers, Importers, Exporters, Distributors, and Holders of certificates of Registration (HCR) of medical devices. It represents the South African Health Products Regulatory Authority’s (SAHPRA) current thinking on the safety, quality, and performance of medical devices. It is...

09 Sep Guidelines on Clinical Evaluation of Medical Devices

Posted at 10:33h in

This guideline is intended to clarify the requirements of conducting a clinical evaluation of a medical device in South Africa. It represents the South African Health Products Regulatory Authority’s (SAHPRA)’s current thinking on the safety, quality and performance of medical devices under clinical investigation. It...

09 Sep Guideline on Clinical Investigation of Medical Devices

Posted at 10:07h in

This guideline is intended to clarify the requirements of conducting a clinical investigation in a medical device in South Africa. It represents the South African Health Products Regulatory Authority’s (SAHPRA)’s current thinking on the safety, quality and performance of medical devices under clinical investigation. It...

29 Aug Reprocessing of Single Use Medical Devices

Posted at 11:28h in

This document is intended to communicate the position of the South African Health Products Regulatory Authority (SAHPRA) on reprocessing of single use medical devices to stakeholders....

19 Aug Regulatory Requirements of Artificial Intelligence and Machine Learning (AI/ML) Enabled Medical Devices

Posted at 19:57h in

This communication is intended to provide industry stakeholders with the regulatory requirements of Artificial Intelligence and Machine Learning (AI/ML)-enabled medical devices in South Africa....

17 Jul Medical Device Establishment Licence Renewal Process

Posted at 13:15h in

The Medicines and Related Substances Act 101 of 1965, as amended, read together with the Regulations related to Medical Devices and IVDs, provides for the regulatory oversight of Medical Devices, including In Vitro Diagnostics (IVDs) in South Africa. In terms of Section 22C(1)(b) of the...

Archive