If your company designs or develops, manufactures, imports, distributes or provides technical support for medical devices you will need to comply with this standard to trade.

The South African Medical Device landscape has changed extensively with the passing of the Medicines and Related Substances Amendment Act 14 of 2015 that established an independent body – the South African Health Products Regulatory Authority (SAHPRA) and the recent publishing of the new Medical Device Regulations.

The Quality Management System approach provides many benefits including:
Product or service quality:

Consistent and predictable product or service quality. Reduction in mistakes, wastage, and possible product recalls.


Wider acceptance of products and/or services in target markets.


Regulatory compliance. Easier product license renewals. Easier registration of new products.

What can Quality Track do for you?

An easy to follow 4 stage project plan – Gathering of information – preparation of documentation, implementation and training and preparation for certification. Preparation of all documentation for your approval. Staff training. A detailed guide to successful implementation. Close monitoring your implementation progress. Assistance in choosing a suitable certification company. Assistance to close out any findings arising from certification audits to ensure successful certification.