SAHPRA Brings More Clarity on RUO and IUO Medical Devices
The South African Health Products Regulatory Authority (SAHPRA) has issued new guidance on Research Use Only (RUO) and Investigational Use Only (IUO) medical devices, including IVDs. This article explains the key regulatory clarifications on intended use, product labelling, import requirements, Section 21 authorisation and what manufacturers, importers and research organisations should consider to ensure compliance.
