Medtech Regulations Library

Disclaimer: The South African Medical Technology Industry Association (SAMED) provides this content as a complimentary service. The content is not a substitute for appropriate legal advice and is not binding on SAMED. SAMED, its board members, committees, employees and members, will not be responsible for any inaccuracies or omissions, or, liable for any damages or loss of whatsoever nature suffered by any person as a result of relying on or using the content provided.

The South African Health Products Regulatory Authority (SAHPRA)

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SAMED Position Paper & Principles of SA Medical Device Regulation

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SAMED Submissions on South African Medical Device Regulation

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Technology and medical professional

Medical Device and IVDs Regulations: guidance documents

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African Medical Device & IVD Regulatory Resources

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Post-market surveillance, vigilance and recall resources

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18 A & 18 B Exemption Notice for Medical Devices and IVDs

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ISO 13485 Communications and Resources

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International Medical Device Regulators Forum

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Global Harmonization Working Party

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