Nirmed Archives

18 Aug Guideline for the Completion of the Annual Submission of Compliance Information Form

Posted at 15:22h in

The objective of this guideline is to give clear guidance on the Annual Submission of Compliance Information process from the perspective of an importer/ License Holder and Completion of the Annual Submission of Compliance Information Form (OF-RDN-NM-06A, replacing Old Form: 41BM-2)....

25 Feb Guideline for the Application of a License to Install, Use, Operate, and Apply for Magnetic Resonance Imaging (MRI)

Posted at 09:06h in

The purpose of this document is to guide applicants seeking a license to install and use Magnetic Resonance Imaging (MRI) equipment. It outlines the necessary processes involved in applying for a license, the required supporting documents, and safety requirements. This guideline represents the minimum standards...

25 Feb Guideline for Licence Applications for Non-ionising Radiation Medical and Non-medical Devices Classified as Listed Electronic Products

Posted at 09:04h in

This guideline is intended to guide applicants wishing to submit applications for the listed electronic products. It represents the South African Health Products Regulatory Authority's (SAHPRA)’s current thinking on the safety, quality, and performance of the listed electronic products....

16 Feb Regulatory Process for Magnetic Resonance Imaging (MRI) Equipment

Posted at 13:42h in

This communication is intended to guide relevant industries on the regulatory process for Magnetic Resonance Imaging (MRI) equipment. MRI equipment falls within the definition of electronic products and is classified as Group III under the Hazardous Substances Act 15 of 1973. MRIs are also listed...

16 Feb Regulatory Requirements for License Applications for Importation, Manufacturing and Use of Laser Systems

Posted at 13:40h in

This communication is aimed at guiding Applicants on the licensing process regarding the importation and use of laser systems in terms of the Hazardous Substances Act, Act 15 of 1973....

16 Feb Regulatory Process of Annual Submission of Compliance Information (ASOCI)

Posted at 13:38h in

This communication is intended to guide license holders who import electromedical products through the annual submission of compliance information (ASOCI) process. This process is done in terms of section 5 of the Hazardous Substances Act 15 of 1973...

14 Mar Application for a Licence to Use, Operate, Apply Install or Keep Installed an MRI Device System (Veterinary)

Posted at 11:15h in

Application for a Licence to Use Operate Apply Install or Keep Installed an MRI Device System (Veterinary) APPLICATIONS MUST ONLY BE SENT THROUGH DESIGNATED EMAIL ADDRESSES: Applications: nirmed.application@sahpra.org.za Enquiries: nirmed.enquiry@sahpra.org.za ...

14 Mar Application for a Licence to Use Operate Apply Install or Keep Installed a Magnetic Resonance Imaging (MRI) Device System (Medical)

Posted at 11:14h in

Application for a Licence to Use Operate Apply Install or Keep Installed a Magnetic Resonance Imaging (MRI) Device System (Medical) APPLICATIONS MUST ONLY BE SENT THROUGH DESIGNATED EMAIL ADDRESSES: Applications: nirmed.application@sahpra.org.za Enquiries: nirmed.enquiry@sahpra.org.za ...

14 Mar Application for a licence to use a non-medical laser

Posted at 11:12h in

Hazardous Substances Act, 1973 (Act 15 of 1973)...

14 Mar Application for a licence to use a medical laser

Posted at 11:11h in

Section 4(1)(b)&(c), Hazardous Substances Act, 1973 (Act 15 of 1973)....

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