IN exercise of the powers conferred by subsection 79(2) of the Medical Device Act 2012 [Act 737], the Minister makes the following regulations:
1. Citation and commencement · Citation and commencement
(1) These regulations may be cited as the Medical Device (Amendment) Regulations 2025. (2) These Regulations come into operation on 1 January 2026.
2. Amendment of Fifth Schedule · Amendment of Fifth Schedule
The Medical Device Regulations 2012 [P.U. (A) 500/2012] are amended in the Fifth Schedule in column description of fees— (a) in relation to subitem 1(1)(a)(i), in column fee payable (RM), by substituting for the word “100” the word “500”; and (b) in relation to subitem 1(1)(b)(i), in column fee payable (RM), by substituting for the hyphen the word “750”. Made 20 August 2025 [KKMMDA(S)100/1-1-1; PN(PU2)711/V] DATUK SERI DR. HAJI DZULKEFLY BIN AHMAD Minister of Health