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Dedication to Quality
Ubuntu MedTech Access is a South African Authorised Representative (AR) regulatory services company that helps international medical device manufacturers gain market access in South Africa under SAHPRA. It is run by a sole practitioner, Cebisile Madi, based in Johannesburg, South Africa, and is aligned to ISO 13485. We provide a single point of regulatory contact, ensuring technical precision and professional credibility for manufacturers already holding FDA/EU/other reference approvals.
International Standards
Our quality management system is fully aligned with ISO 13485:2016, ensuring that every regulatory submission meets the highest international standards for medical device safety and performance.
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