The following are the differences in this Fourth Edition:
- 1. For general requirements, the usage of a QR code from medical device registration certificate to indicate medical device registration number is encouraged.
- 2. Customers/users can access the medical device registration number, manufacturer/authorised representative data, and QR code display on the label.
- 3. The location of the translation information needs to be determined by a risk assessment exercise and submitted during registration.
- 4. Decommissioning or disposal information must be included on the label of a medical device.
- 5. MDA has introduced a new subsection that explains electronic labelling;
- a) Electronic IFU (E-IFU) is only applicable to medical devices intended for professional use.
- b) For home use devices, paper-form IFU is required, and electronic IFU is optional. However, the manufacturer/AR shall ensure that the electronic label and the printed IFU approved in product registration are similar.
- 6. The usage of the MDA logo and “Medical Device Authority (MDA)” and/or Ministry of Health Malaysia” are prohibited in all labelling.
Below are the conditions for a medical device that needs to have specific contents of labelling:
- a) Purpose of demo:
- Please refer to the guidance document (MDA/GD/0018) on Import and/or supply of unregistered medical devices for the purpose of demonstration for marketing or education.
- b) For the purpose of clinical research:
- Please refer to the guidance document (MDA/GD/0016) on Notification of Exemption from Registration of Medical Devices for The Purpose of Clinical Research or Performance Evaluation.
Please visit the Guidance Document on MDA's website for further information on the most recent revisions to the Requirements for Labelling of Medical Devices in Malaysia.