PUBLICATION OF SEVENTH EDITION OF GUIDANCE DOCUMENT ON REQUIREMENTS FOR LABELLING OF MEDICAL DEVICES

 The Medical Device Authority (MDA) wishes to inform industry players and healthcare providers that an updated guidance document has been issued on the implementation of e-labelling for home-use medical devices.

This guidance document provides guidance for manufacturers on implementing e-labelling for home-use medical devices. It ensures that essential device information is accessible to users while maintaining user safety, device performance, and regulatory compliance. The e-labelling approach is permitted provided that the manufacturer conducts a risk assessment demonstrating that safety and usability requirements are met.

This guidance document shall be read in conjunction with the current laws and regulations used in Malaysia, which include but not limited to the following-

a) Medical Device Act 2012 (Act 737);

b) Medical Device Regulations

To view the guidance document, CLICK HERE

For further inquiries, please contact:

Guidance Document Unit, Policy and Strategic Planning Division (DASAR) MDA:

  • Mohd Naquib : +603-8230 0209
  • Anis Suhaila: +603-8230 0236
  • Nur Syaza: +603-8230 0362
  • 📧 Email: guidance [email protected]