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Malaysia Medical Device Labeling
Medical device labeling requirements in Malaysia are outlined in the Medical Device Authority‘s (MDA) 2018 Guidance Document. The MDA issued the Fifth Edition for comment in April 2022. While many of the requirements remain the same, one new provision is that the MDA is allowing and encouraging manufacturers to use a QR code for the registration number.
The general labeling requirements are as follows: the medium, format, content, readability and location of the label should be appropriate for the device and should contain as much information as possible for the user to be able to identify and safely use the product. When Instructions For Use (IFU) is included, it should be written using clear language. Note that low and moderate risk medical devices do not require IFUs. Paper versions of all labelling must accompany the product.
All products should be labeled in English. Products intended for home use should be labeled in both English and Bahasa Malaysia.
The label cannot claim promotion or endorsement by the Ministry of Health or Medical Device Authority or any related organizational bodies.
General Device Labeling Requirements
- Name, model, batch, serial number, date of manufacturing/date of expiry
- Malaysian medical device registration number
- Manufacturer Name, Address, Tel. No., Web address
- Technical details
- Description and intended use
- Undesirable side effect, limitations, warnings and precautions
- Post-market servicing requirements
- Decommissioning/disposal information
Beginning August 2021, the following additional labeling information will be required:
- Name and Address of the Authorized Representative
- Product License Number
- Home use products must have the instructions available in the local Bahasa Malaysia language
Some devices require additional labeling contents, including:
- Identifications of custom medical devices
- Indication for special storage
- Verification of correct installations
- Requirements for further treatment and handling (sterilization, calibration, etc.)
- Indication for single-use medical devices
- Identification of devices intended for clinical and/or performance testing, research or educational purposes
- Indication of refurbishment
Circular letter No 1, Year 2017 Rev 1 states that Medical Devices intended for export only are exempted for labeling requirements, given:
- The device complies with the labeling requirements of the country for export
- Device labeling as “export only”
- Device is not intended to be placed on the Malaysian market
IVD Specific Requirements
IVD products must adhere to additional requirements on top of the above outlined Medical Device guidelines.
IVD products will also need to include:
- Intended Purposes (type of analyte of the assay, qualitative vs. quantitative, traceability information, etc.)
- Test principle
- Assay procedure, including calculation and interpretations
- Specimen type
- Performance characteristics
- Conditions for collections
- Reference Intervals
- Reagent description and any limitation
- Study design
Contact Asia Actual to see if our Malaysia labeling solutions are right for your needs.
Malaysia Regulatory Support
US: +1 512 898-9222