Medical Devices Archives - Page 2 of 10

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...

16 Jul Contact Details for Guideline SAHPGL-MD-03 Medical Device Vigilance: Adverse Events Reporting for License Holders

Posted at 15:01h in

This document is intended to provide contact details for communicating reportable adverse events, as per Guideline SAHPGL-MD-03, as well as contact details for any Recalls and Market actions for medical devices (including IVDs). Reportable adverse event reports must be emailed to: mdvigilance@sahpra.org.za....

23 Jun Regulatory Requirements for Veterinary Medical Devices (Including in-vitro Diagnostic Veterinary Medical Devices)

Posted at 11:17h in

The Medicines and Related Substances Act, 1965 (Act 101 of 1965) as amended, read in conjunction with the General Regulations on Medical Devices, published in Government Gazette Notice 40480, No.1515 of 9 December 2016, provides for the regulatory oversight of veterinary medical devices including In-Vitro...

09 Apr MPXV Molecular Technical Review Application

Posted at 14:43h in

MPXV molecular test kit/s that have not been listed, registered or authorised for use in a jurisdiction recognised by the South African Health Products Regulatory Authority (SAHPRA) or that have not been pre-qualified by the World Health Organisation (WHO) will be screened against the minimal...

09 Apr Mpox Diagnostic Test Kit Regulatory Requirements

Posted at 14:41h in

The first human case of Mpox was reported in the Democratic Republic of Congo; the outbreak has since spread to other countries, including South Africa. South Africa is currently experiencing an outbreak of Mpox clade II. Mpox (previously known as Monkeypox) is an infectious disease...

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