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
Description and intended use
Undesirable side effect, limitations, warnings and precautions
Post-market servicing requirements
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.)
Assay procedure, including calculation and interpretations
Conditions for collections
Reagent description and any limitation
Contact Asia Actual to see if our Malaysia labeling solutions are right for your needs.