Draft statutory instrument (no number assigned)

The draft Botswana device regulation: 127 regulations in 23 Parts, made under sections 80, 81, 82 and 123 of the Medicines and Related Substances Act, 2025. It is the instrument that would introduce device classification (Part on classification, regulations 5 and 6), the essential principles (defined in regulation 2 and set out in Schedule 3; regulation 9 is the application for registration), UDI (Part XII, regulations 95 to 97; regulation 88 is materiovigilance and regulation 92 periodic safety update reports), conformity assessment, registration and licensing. It is an UNMADE DRAFT and is recorded as one: the text reads "(Published on __________, 2026)" with the date left blank, the closing signature block reads "Made this ______________ day of _________________________, 2026. ____ Minister of Health" and is unsigned, and no statutory-instrument number is stated anywhere. Regulation 1(2) defers commencement to a ministerial Order. The draft carries a further internal inconsistency worth knowing: the running footer over the Schedules reads "Medical Devices Regulations, 2025 - Schedules and Prescribed Forms" while the body throughout is the 2026 Regulations. Four Schedules are ingested with it — classification rules for devices, classification rules for IVDs, the essential principles, and the UDI implementation timeline.

Draft statutory instrument (no number assigned) is the official identifier BoMRA uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.