Medical Devices Archives - Page 5 of 12

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...

09 Apr Mpox Diagnostic Tests

Posted at 14:39h in

This communication is intended to provide an update to industry stakeholders concerning Mpox (formerly monkeypox) diagnostic tests in South Africa. The regulatory requirements for Mpox diagnostics can be found in Communication to Industry: Issue No.: MD01-2024/25 v1...

09 Apr ISO 13485 Certificate as a prerequisite for the approval of a Medical Device Establishment Licence

Posted at 14:23h in

The international standard ISO 13485 (ISO 13485:2016 Medical Devices - Quality Management Systems – Requirements for regulatory purposes) for a quality management system (QMS) is recognised globally to address minimum regulatory requirements for medical devices and in vitro diagnostics (IVDs). The standard outlines the requirements...

13 Dec Medical Device Adverse Event Reporting Form

Posted at 11:04h in

This document is intended to assist the holder of a medical device establishment licence (referred to as the “licensee)” and the holder of a certificate of Registration (HCR) in the reporting of an adverse event associated with the use of a medical device (including an...

13 Dec Guideline for Completing Medical Device Adverse Event Form for Licensed Holders (Licensee) / Holders of a Certificate Of Registration of al Medical Device (including an IVD)

Posted at 10:31h in

This guideline provides the information to be supplied to SAHPRA when completing the form to report an adverse event for a medical device (including an IVD), it outlines the format and data requirements for reporting of an adverse event, using the Medical Device Adverse Event...

13 Sep Mpox Diagnostic Tests

Posted at 14:45h in

This communication is intended to provide an update to industry stakeholders concerning Mpox (formerly monkeypox) diagnostic tests in South Africa....

05 Jun Contact details for Guideline SAHPGL-MD-03 Medical Device Vigilance: Adverse Events Reporting for License Holders

Posted at 19:40h 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 events reports must be emailed to mdvigilance@sahpra.org.za and copy (cc) Puseletso.Mogano@sahpra.org.za...

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