Government Notice 88 of 1998

Complete original government Gazette instrument: all 55 pages (printed 375–429), 50 regulations and ten schedules, including the original enacting formula, making clause of 30 August 1998, Minister Harry Thomson and Government Printer terminal. Published on 4 December 1998; no exact commencement date is inferred. The scanned original is supplied by the RRFA professional association, not a government host. Every page was visually transcribed and retained as an original page image; source numbering and printed errors are preserved. Regulation 12(3) requires applicants to inform the Board without delay of specified alterations to information or particulars before or after registration. The two months in regulation 12(5) is a retention-application lead time, and regulation 18(3) requires return of an endorsed certificate within a reasonable period; these are not fixed device variation approval days. Second Schedule category 15 explicitly includes serological tests, blood grouping and reagent strips/tablets; categories 21.4 and 21.5 include intrauterine and barrier devices. The instrument therefore cannot be excluded wholesale as medicine-only on its title. The 2019 Act section 130 conditionally preserves prior subsidiary legislation subject to conflict and later replacement; this does not prove the entire 1998 text currently applies to every device or IVD. Later amendments, operative replacements and product-specific applicability remain under review. This dated original is excluded from default current discovery and remains directly readable; it is not a 2026 consolidation.

Government Notice 88 of 1998 is the official identifier MoH / PMPB uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.