Frequently Asked Questions - Labelling of Medical Devices

FAQs - Labelling of Medical Devices
  • Electronic IFU (e-IFU) is eligible for devices that are limited to those intended for use by professional users only. 
  • Users should always have the choice to obtain the content of the eIFU in paper form on request, without undue delay or within the time period specified in the risk assessment, and at no additional cost.
  • For information downloadable from the internet, the internet web address shall be clearly printed on the physical label of the device and displayed in such a manner that highlights to the user its purpose. The manufacturer /AR shall ensure that the electronic label is identical with the printed IFU approved in the product registration.
  • Manufacturers shall conduct and document a risk analysis for implementation of electronic IFUs and maintain records of this analysis. Specific points to address include:
    1. Does the intended user have the required level of experience and the means to use the electronic IFU (e.g. a computer with internet access at or near the device’s point of use, CD/DVD Drive or a compatible web-browser)?
    2. Are there back-up methods for accessing the electronic/hard-copy IFU?
    3. Are there processes in place to ensure ongoing security of electronic IFU?
  • Manufacturers shall have defined procedures and processes for the establishment and revisions to electronic documents.
  • Paper-form IFU is required and additional electronic IFU is optional for home use devices

Note: Any changes to the electronic label shall comply with the specified requirements in Guidance on Change Notification for Registered Medical Devices (MDA/GD/0020).

  • E-IFU is eligible for medical device intended for use by professional users only. 
  • Paper-form IFU is required and additional electronic IFU is optional for home use devices
TAGS: Labelling

AR information and registration number shall be on the packaging where the information can be accessed at the point of receiving by the customers/users.

  • Overlabelling using stickers is allowed, as long as there is no over labeling on the lot/batch or serial number, date of manufacturing and date of expiry.

It is allowed to have other regulatory approval information in the labelling.

-AR details
 -Registration number

  • For new products registered, labelling include AR details and Registration number do not require change notification. The labelling with this information shall also submitted during Re-registration.

Product manual is recommended to be in printed form. However, electronic form is allowed to be provided subject to the following conditions

  • Manufacturers shall conduct and document a risk analysis for implementation of electronic manuals and maintain records of this analysis. Specific points to address include:
    1. Does the intended user have the required level of experience and the means to use the electronic  (e.g. a computer with internet access at or near the device’s point of use, CD/DVD Drive or a compatible web-browser)?
    2. Are there back-up methods for accessing the electronic/hard-copy manuals?
    3. Are there processes in place to ensure ongoing security of electronic manuals?
  • Manufacturers shall have defined procedures and processes for the establishment and revisions to electronic documents.
  • The manufacturing date is not necessary to be included in all labelling. However, the labelling shall consist of at least one of the information below (refer to guidance document labelling clause 4.8 b.):-
    1. An indication of batch code/lot number/serial number; 
    2. Expiry date;
    3. Shelf life; or
    4. Manufacturing date
  • The new AR need to relabel with new AR details in the labelling of stocks taken from old AR before placing them in the market.
  • The products needs to comply with labelling requirements of the importing countries.
  • All the information in the labelling need to be translated into Bahasa Malaysia for home use device except for brand name, proper nouns and words that are the same in both languages.
  • If the accessory is supplied separately, a separate labelling shall be provided
  • Manufacturing date: Day, Month and year, if only the manufacturing date is provided in the labelling. If other information such as lot/batch or serial number or expiry date has been provided, the manufacturer may decide to write the manufacturing date either in full (dd/mm/yyyy) or month and year (mm/yyyy)
  • Expiry date: at least as the year and month 
  • Additional labelling on Medical Device Registration Number, AR information, and Bahasa Malaysia translation does not require approval from the manufacturer.

1. Berkaitan pernyataan "KEMENTERIAN KESIHATAN MALAYSIA", adakah pernyataan ini dibenarkan pada label produk jika kami menyalurkan produk ini ke hospital-hospital swastafarmasi swasta dan lain-lain institusi selain hospital-hospital awam?. Adakah penggunaan pernyataan tersebut merupakan suatu endorsement dan larangan dalam akta peranti perubatan?


 2. Adakah penggunaan singkatan 'KKM' dibenarkan pada label produk jika ia disalurkan pada sektor swasta?adakah singkatan ini merupakan satu endorsement?


 3. Berkaitan isu endorsement apakah contoh-contoh endorsement yang dibenarkan dan tidak dibenarkan?

  • Kegunaan nama KKM atau MDA sudah melambangkan “endorsement” dan penggunaanya tidak dibenarkan.
  • Untuk pembekalan kepada KKM jika ada arahan untuk pembekalan, adalah dibenarkan untuk menggunakan perkataan “Kementerian Kesihatan Malaysia”.
  • Halal logo is not a requirement for medical device labelling. You may chose not to put it in. However if you label your product with a halal logo, you will need Halal certification first from JAKIM.
  • The original labelling together with registration number shall comply with labelling requirements.
  Medical Device Authority (MDA),
Ministry of Health Malaysia,
Level 6, Prima 9, Prima Avenue II,
Block 3547, Persiaran APEC,
63000 Cyberjaya, Selangor, MALAYSIA

  +603 - 8230 0300
  +603 - 8230 0200 
  mdb@mda.gov.my

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  • Last Modified: 03 August 2021.
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