SAHPRA Recognized QMS Certificates

The Medical Devices Unit of the South African Health Products Regulatory Agency (SAHPRA) regulates the licencing of medical device establishments and the registration of medical devices in South Africa to ensure the availability of medical devices that comply with an acceptable level of safety, quality and performance. ISO 13485 certification is a prerequisite for the application or renewal of a medical device licence, with effect from 1 April 2025. From that date, SAHPRA requires all medical device manufacturers and distributors to hold an ISO 13485 certification from a SAHPRA-recognized certification body. 

Intertek Medical Notified Body AB has registered with SAPHRA in recognition of SWEDAC accredited ISO 13485 certificates: List of Recognised Conformity Assessment Bodies - SAHPRA

This means that manufacturers wishing to enter the South African market, can utilize their ISO 13485 certificates under SWEDAC issued by Intertek, as part of market access requirements.

To obtain the SAHPRA scheme to your ISO 13485 certification service please contact us at imnb@intertek.com 

Global Market Access for Medical Device Manufacturers - Partner with Intertek and gain the confidence of knowing you have a solid Quality Management System in place for medical devices,

Intertek’s medical devices auditing and certification services: Medical Devices Auditing and Certification Services