Guideline Archives - Page 13 of 16

25 Jan Guideline for a License to Manufacture, Import, Export, or Distribute Medical Devices and IVDs

Posted at 13:03h in

This guideline is intended to provide recommendations to applicants wishing to submit applications for the manufacture, importation, distribution and exportation of Class B, Class C and Class D medical devices and In Vitro diagnostics (IVDs). It represents the South African Health Products Regulatory Authority current...

25 Jan Guideline on Medical Device Quality Manual

Posted at 12:53h in

This guideline is intended to provide recommendations to applicants wishing to submit applications for a licence to manufacture, import, distribute and export a medical device, including In Vitro diagnostics medical devices (IVDs). It represents the South African Health Products Regulatory Authority’s current thinking on the...

25 Jan Guideline for Classification of Medical Devices and IVDs

Posted at 12:52h in

This guideline is intended to provide recommendations to interested persons wishing to submit applications for the licensing of manufacturers, distributors and wholesalers, and registration of medical devices and IVDs. It represents the Authority’s current thinking on the safety, quality and performance of medical devices and...

25 Jan Guideline for Medical Device Adverse Event Reporting

Posted at 12:49h in

This guideline provides a reference document detailing the regulatory requirements for reporting of an adverse event for a medical device (including an IVD) in South Africa and describes the information to be supplied to the South African Health Products Regulatory Authority (SAHPRA). This guideline is...

25 Jan Guideline for Donation of Medicines, Medical Devices, and IVDs

Posted at 12:46h in

This guideline provides an outline of the principles and process to be followed in the donation of medicines, medical devices, and in vitro diagnostics (IVDs). The guideline applies to both people and entities wishing to make donations and the recipients of such donations. The South African...

25 Jan CMs Specified Substances

Posted at 12:22h in

This guideline is intended to provide recommendations to applicants wishing to submit applications for the registration of Complementary Medicines containing specified substances. In addition to this guideline, SAHPRA reserves the right to request any additional information to establish the safety, quality and efficacy of...

25 Jan Complementary Medicines Registration Application ZA-CTD-Quality

Posted at 12:21h in

This guideline is intended to provide recommendations to applicants wishing to submit applications for the registration of Complementary Medicines. It represents the South African Health...

25 Jan Complementary Medicines – Health Supplements Safety and Efficacy

Posted at 11:58h in

This guideline is intended to provide recommendations to applicants wishing to submit applications for the registration of Health Supplements. It represents the South African Health Product Regulatory Authority’s current thinking on the quality, safety, and efficacy of these medicines. It is not intended as an...

25 Jan Complementary Medicines – Use of the ZA-CTD format in the preparation of registration applications

Posted at 11:57h in

This guideline is intended to provide recommendations to applicants wishing to submit applications for the registration of Complementary Medicines intends to invite comment from ...

25 Jan Roadmap for CMs

Posted at 11:56h in

This document has been prepared to serve as guidance to stakeholders regarding the regulation pathway of Category D medicines ( complementary medicines registration. It represe...

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