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South Africa's (SAPHRA): Import Applications Of Electronic Devices Emitting Ionizing Radiation

Earlier today (16 January, 2024) the South African Health Products Regulatory Authority (SAPHRA) released an updated Guideline For "Import Applications Of Electronic Devices Emitting Ionizing Radiation".

In accordance with Hazardous Substances Act 15, 1973, this guideline summarizes the procedures to follow, forms to fill out, and other requirements in connection with a license application for electronic devices emitting ionizing radiation.

Among the guidelines in this document are the requirements and recommendations for obtaining a license for importing medical, dental, veterinary, and industrial electronic devices emitting ionizing radiation.

It is the primary importer's duty to comply with the requirements and stipulations of the Hazardous Substances Act 15, 1973 and any conditions that SAHPRA decides are applicable to importing devices into South Africa. The primary importer is the natural person in contact with the international manufacturer for importing their devices into South Africa.

All devices that have a CE mark must have a technical file that must contain the information that proves that the device conforms with the EU directives and regulations for CE-marked devices. A technical file is a set of documents that describes a device and can prove that the device was designed in accordance with the requirements of a quality management system.

To know in detail about the requirements and the supporting documents the licensing conditions, etc click this LINK.


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