Malaysia medical device regulations

Medical Device (Designated Medical Device) Order 2026 (P.U. (A) 10/2026), made under section 26 of Act 737: it specifies the devices requiring a designated medical device permit — medical lasers, HIFU, liposuction devices and others — with their permitted purposes in the Schedule. Official bilingual gazette PDF, Malay and English halves ingested as separate corpus sources.

Medical Device (Amendment) Regulations 2025 (P.U. (A) 330/2025), made under subsection 79(2) of Act 737 and in operation 1 January 2026. Amends the Fifth Schedule of the Medical Device Regulations 2012 [P.U. (A) 500/2012]: the fee for subitem 1(1)(a)(i) rises from RM100 to RM500 and subitem 1(1)(b)(i) changes from a hyphen to RM750. Official bilingual gazette PDF, Malay and English halves ingested as separate corpus sources.

Medical Device (Exemption) Order 2024 (P.U. (A) 78/2024), in operation 5 March 2024 (regulations 1-6): exempts devices for personal use, demonstration for marketing, education, clinical research, special-access and obsolete devices from registration and establishment licensing, and Class A devices from conformity assessment; regulation 6 revokes the Medical Device (Exemption) Order 2016 [P.U. (A) 103/2016] with a saving. Official bilingual gazette PDF (the doclink route serves the file despite the embedded token predating download), Malay and English halves ingested as separate corpus sources.

Collection of guidance documents to help industry comply with Medical Device Act 737 and regulations. Covers classification, registration, labeling, and QMS requirements.

Collection of all medical device legislation including Act 737, Act 738, Medical Device Regulations 2012, and subsequent amendments.

Comprehensive registration information including requirements for Class A-D devices, conformity assessment bodies, and registration pathways.

Malaysia uses ASEAN-aligned risk-based classification: Class A (low risk), Class B (low-moderate), Class C (moderate-high), Class D (high risk). Classification determines registration pathway.

Official MDA portal for device registration, establishment licensing, and regulatory submissions. Provides access to MDAR online registration system.

Primary legislation governing medical devices in Malaysia: registration, conformity assessment bodies, establishment licences, designated-device permits, advertising, enforcement, and appeals across Parts I-V (sections 1-80). Exact English Laws of Malaysia reprint PDF from the MDA legislation collection; the previously recorded mda.gov.my/documents URL still returns HTTP 403, but the www.mda.gov.my/ms/dokumen file route serves the same document. Ingested as sec-1 through sec-80 with part and chapter blocks.

Medical Device (Advertising) Regulations 2019 (P.U. (A) 317/2019), gazetted 15 November 2019. The official MDA file (1.19 MB, five pages) is a scanned image PDF with no text layer, so it cannot be ingested as citeable text; no OCR substitute is used. Re-ingestion requires an official text-layer copy.

Medical Device Regulations (Duties and Obligations of Establishments) 2019 (P.U. (A) 318/2019), gazetted 15 November 2019. Re-fetched 2026-08-29: the docman endpoint now delivers the complete official PDF (5,948,669 bytes), but it is an image-only scan like P.U. (A) 317 — no font resources, 20 JPEG-encoded pages, zero extractable characters — so it cannot be ingested as citeable text and no OCR substitute is used. Re-ingestion requires an official text-layer copy.

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.