Malaysia medical device labeling
Medical devices sold in Malaysia must be labeled according to the Medical Device Authority’s (MDA) requirements.
Overview of Malaysia medical device labeling requirements
Medical devices sold in Malaysia must be labeled according to the Medical Device Authority’s (MDA) requirements. Labeling comprises the device label and Instructions for Use (IFU), which is the accompanying leaflet, manual, packaging insert. When possible, the information needed to identify and use the medical device safely should be provided on the device itself or its permanent label. Otherwise it should be provided on the device packaging, secondary packaging, or the IFU.
Medical device labels should include the Malaysian medical device registration number. MDA encourages the use of the QR code from the registration certificate to indicate the device’s registration number. At minimum, the label should include the device name, model, batch or serial number, date of manufacturing, and/or date of expiration. Other labeling requirements include:
- Manufacturer Name, Address, phone number, website URL
- Technical details
- Description and intended use
- Undesirable side effect, limitations, warnings and precautions
- Post-market servicing requirements
- Decommissioning or disposal information
- Name and Address of the Authorized Representative
- Product License Number
The label cannot claim or imply endorsement by the Malaysian Ministry of Health, Medical Device Authority, or any other regulatory authorities. All labels and labeling must be submitted to MDA for approval with your device registration dossier.
Translation requirements for Malaysia medical device labeling
In general, medical device labels must be provided in English. However, Bahasa Malaysia must be used for home-use medical devices. MDA also encourages the use of internationally-recognized symbols to communicate necessary safety information where appropriate and applicable.
Medical Device Instructions for Use (IFU) in Malaysia
Instructions for Use (IFU) is information provided with the medical device or IVD as an extension of its labeling. In Malaysia, the IFU should address details on contra-indications, warnings, and precautions that should be taken when using the device, as well as a summary of the safety and clinical performance of the device. However, IFU may not be required or necessary for some low and moderate-risk devices.
In general, paper copies of labeling and IFU must be provided with the device. E-labeling is permitted for devices intended for use only by healthcare professionals. However, the manufacturer must perform and document a risk assessment to identify any potential risks to the user or patient before implementing electronic IFU. All IFU must be dated or marked with a version number.
