Medical device labelling requirements in Malaysia.

What the label must show.

Regulation 16 requires the manufacturer to label the device as set out in the Sixth Schedule, and the label must be legible, permanent and prominent. The general contents (paragraph 6):

Paragraph 7 adds specific items, such as sterile, single-use, reusable, custom-made, implantable and radiation-emitting devices; paragraph 8 covers IFU contents; and paragraph 9 adds extra contents for IVDs. Since MDA’s 22 May 2026 announcement, foreign manufacturers must give a name and address; contact details are optional.

Bahasa Malaysia: home-use devices

Home-use devices must be labelled in Bahasa Malaysia (Sixth Schedule, paragraph 5; MDA/GD/0026 section 4.7). Home use means use by lay persons outside a professional healthcare facility, which includes self-test devices. MDA’s FAQ is explicit that all labelling is translated, not only the IFU; brand names, proper nouns and words identical in both languages are exempt. Other devices may be labelled in English, and additional languages are optional. MDA may require Bahasa Malaysia for other device types too.

The registration number and local overlabelling

• The Malaysian registration number must be on the label within 6 months of registration; using the QR code from the registration certificate is encouraged (MDA/GD/0026, section 4.1).
• The registration number, manufacturer and AR details and the QR code must be visible to customers at the point of sale (section 4.5).
• Labelling may be completed after import or manufacture but before the device is placed on the market, and must match the registration submission (section 4.4).
• Sticker overlabels for the AR, importer or translation are allowed if they stay legible and durable for the shelf life. Never cover the lot, batch or serial number or the manufacturing and expiry dates.
• Adding the registration number, AR details or a Bahasa Malaysia translation does not need the manufacturer’s approval or a change notification.
• When a registration changes owner, the new AR relabels existing stock with its own details.
• At re-registration MDA expects the updated label showing the registration number and AR details. See MDA renewals.

Relabelling is also a distribution activity that GDPMD auditors check: see gdpmd.my for the GDPMD side.

Symbols and e-IFU

MDA/GD/0026 asks for international labelling standards where applicable and encourages recognised symbols, explained where their meaning is not obvious (section 4.6). It does not name a specific symbols standard.

An e-IFU is allowed for professional-use devices, and for home-use devices only where a documented risk analysis supports it (sections 4.12–4.13). The label must print the web address; access is by QR code, barcode or URL; the e-IFU must be viewable offline and show its version; paper copies must be free on request. Changes to an e-IFU follow MDA’s change notification guidance.

What is not yet in force

• UDI. MDA’s July 2024 announcement proposed voluntary UDI from 2026, Class D mandatory in 2027 and other classes in 2028, with full compliance by 2030, once decided and once MeDC@St 3.0+ is complete. No later announcement has made it binding, so UDI is optional for now.
• Hologram security label. On 5 August 2026 MDA announced that the Ministry of Health will phase in a hologram security label for registered medical devices. No mechanics or dates have been published yet; we will update this page when they are.

Label mistakes that delay registration

• No Bahasa Malaysia on a home-use or self-test device, or only the IFU translated.
• Missing AR name and address on a device made outside Malaysia.
• An overlabel that hides the lot number or expiry date.
• Label content that differs from the intended use or models in the registration.
• “MDA approved”, the MDA logo or the Ministry of Health name on the label.

Class A labels are checked in section 8 of the MeDC@St form: see Class A registration. For Classes B–D the label sits in the CSDT dossier.