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SAHPRA GN

GN 5855 / GG 52105

Class A medical-device and IVD establishment-licence exemption — GN 5855 (2025)
South AfricaSouth African Health Products Regulatory Authority / Department of HealthGeneralCurrentness under review
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Currentness under review. Whether this instrument remains applicable is under review. Consult the later instruments and source context below before relying on it.

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GN 5855 / GG 52105 is the official SAHPRA identifier for “Class A medical-device and IVD establishment-licence exemption — GN 5855 (2025)”. GN 5855 / GG 52105 is the official identifier SAHPRA uses for this instrument.

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GN 5855 / GG 52105
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About this regulation

Class A medical-device and IVD establishment-licence exemption — GN 5855 (2025)

Complete four-page official Gazette expression of GN 5855, GG 52105, dated 12 February 2025. The operative Class A establishment-licensing exemption and repeal are preserved in their actual wording, including the measuring/sterile and and/or wording and stated three-year period. This does not certify that all Class A devices or IVDs are exempt from all regulatory obligations. No absolute expiry date, present-day legal currentness or question answer is inferred. Complete source images govern; original embedded native text is a qualified search layer.

GN 5855 / GG 52105 is the official identifier SAHPRA uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.

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