This guideline provides information to applicants wishing to submit applications for the use of Class 3B and Class 4 lasers or laser systems...
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)....
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...
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....
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...
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....
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...
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 ...
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 ...
Hazardous Substances Act, 1973 (Act 15 of 1973)...