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Quality Management System

To effectively carry out its regulatory duty, SAHPRA is dedicated to adopting a Quality Management System (QMS) to direct and coordinate the organisation’s activities. By implementing a QMS, we expect to meet and surpass the needs of our stakeholder groups while also improving effectiveness and efficiency of our processes.


In order for SAHPRA to obtain ISO 9001 certification, the entire organisation has embarked on a journey of implementing an effective Quality Management System facilitated by our Quality Management Unit. This will assist SAHPRA in achieving its vision of being an agile and responsive African health products regulator that is globally recognised as an enabler of access to safe, effective and quality health products in South Africa.

Quality Policy Statement

The South African Health Products Regulatory Authority (SAHPRA) is responsible for the: 1) Regulation of health products intended for human and animal use; 2) Licensing of manufacturers, wholesalers and distributors of medicines, medical devices, radiation emitting devices and radioactive nuclides; and 3) Conduct of clinical trials.


QMS Manager

Dudu Ntoko
Tel: 012 501 0372