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MDA P.U.

P.U. (A) 500

Medical Device Regulations 2012
MalaysiaMedical Device AuthorityGeneral
What this code is

P.U. (A) 500 is the official MDA identifier for “Medical Device Regulations 2012”. P.U. (A) 500 is the official identifier MDA uses for this instrument.

Instrument
P.U.
Full name
P.U. (A) 500
Category
General
Source links
Authority source
English and Malay
Issuing-authority publication; confirm whether a later amendment or consolidated version applies.
Readable HTML
0 articles · 2 language versions
Direct citations can link to a specific article or section by appending its fragment identifier.
Dates
Published
31 December 2012
Effective
Readable full text

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Each version has stable article anchors for direct citations and highlighting. The readable text is generated from an authority source and does not replace the legally controlling publication.

About this regulation

Medical Device Regulations 2012

Medical Device Regulations 2012 (P.U. (A) 500/2012): classification and grouping, conformity assessment, registration, establishment licensing, export permits, labelling, appeals, and the register (regulations 1-22) plus the six schedules (classification rules, grouping rules, conformity-assessment procedures, labelling requirements, and fees). Official MDA bilingual gazette PDF — the Malay and English texts are separate language halves, each ingested as its own corpus source. The Fifth Schedule fees were amended by P.U. (A) 330/2025.

P.U. (A) 500 is the official identifier MDA uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.