Labelling Requirements
Overview
Medical device labelling in Malaysia must comply with the requirements of the Medical Device Act 2012 (Act 737), the Medical Device Regulations 2012, and MDA's guidance on labelling. Incorrect or incomplete labelling is an offence under Act 737 and can prevent market entry.
What is "Labelling"?
For regulatory purposes, labelling includes:
- The label attached to the device or its packaging
- The Instructions for Use (IFU)
- Any promotional material making claims about the device's safety or performance
Mandatory Label Elements
The following information must appear on the device label (or on the outer packaging if the label is not readable without opening):
| Element | Requirement |
|---|---|
| Device name | Proprietary name and/or generic name |
| Manufacturer details | Name and address of manufacturer |
| LAR details | Name and address of Malaysian LAR (for imported devices) |
| Device Registration Number (DRN) | Must appear on label after registration |
| Intended purpose | Brief statement of intended use (if not obvious) |
| Model/catalogue number | Product identifier |
| Lot/batch number | Traceability identifier |
| Manufacturing date | Month and year of manufacture |
| Expiry date | Where relevant (use standardised ISO 15223 symbols) |
| Single use designation | Symbol or text if device is for single use only |
| Sterility | Indication of sterile status and sterilisation method |
| Storage conditions | Temperature, humidity, light conditions as applicable |
| Quantity | Number of units in the package |
| Warnings / precautions | Critical safety information |
| ISO 15223 symbols | Symbols used must comply with ISO 15223-1 |
Language Requirements
Primary Language
All labelling information must be in English as a minimum.
Bahasa Malaysia Requirement
For medical devices:
- Supplied to the general public (patients, consumers), labelling must include Bahasa Malaysia
- Supplied exclusively to healthcare professionals in professional settings, English may be sufficient
In practice, most medical devices supplied in Malaysia are labelled in both English and Bahasa Malaysia to cover all distribution scenarios.
Permitted Languages
Additional languages (e.g. Chinese, Tamil) may be included but are not mandatory.
Instructions for Use (IFU)
Every medical device must be accompanied by an IFU unless the device's intended purpose is sufficiently obvious and safe without written instructions.
IFU Must Include:
- Complete intended purpose and indications for use
- Contraindications
- Warnings and precautions
- Instructions for use/operation
- Cleaning, disinfection, and sterilisation instructions (if applicable)
- Maintenance and calibration instructions (if applicable)
- Troubleshooting guidance
- Shelf life and storage conditions
- Manufacturer's name and address
- Malaysian LAR's name and address
- DRN (Device Registration Number)
- Date of issue or revision of IFU
IFU Language
The IFU must be in English and, for devices supplied to the public, also in Bahasa Malaysia.
ISO 15223 Symbols
Use of standardised symbols from ISO 15223-1 is accepted and encouraged for space-limited labels. Where symbols are used, their meaning must be defined in the IFU. Symbols not found in ISO 15223 must be explained on the label.
Labelling for IVDs
In addition to general requirements, IVD labels and IFUs must include:
- Analyte and specimen type
- Analytical measurement range
- Reference intervals (where applicable)
- Interferences
- Principles of the procedure
See In Vitro Diagnostics for full IVD labelling detail.
Changes to Labelling
Changes to labelling after registration are a variation and require prior MDA approval if they are more than administrative corrections. See Change Notification.
The Device Registration Number (DRN) must appear on the label. If a device is registered after initial labelling design, the DRN must be added before supply. Devices supplied without the DRN on the label are non-compliant with Act 737.