malaysia mda releases second edition of guidance on the rules of classification for general medical devices

MALAYSIA MDA Releases Second Edition Of Guidance On The Rules Of Classification For General Medical Devices

Malaysia’s Medical Device Authority (MDA) published the 2nd Edition GUIDANCE ON THE RULES OF CLASSIFICATION FOR GENERAL MEDICAL DEVICES MDA/GD/0009 on 9th May 2022.  

The document aims to provide clear guidance to manufacturers and establishments on how to determine the classification of medical devices. It also aims to allocate its medical device to an appropriate risk class in accordance with Section 2 of the Medical Device Act 2012 (Act 737) and 2012 Medical Device Regulations. This second edition introduces several additions to terms including: central circulatory system, central nervous system, cleaning, continuous use, disinfection, surgically invasive MD, and radiopharmaceuticals.

In addition, in this second edition guidance, MDA has stipulated that in the event of a dispute between an establishment and conformity assessment body over the classification of a medical device, the establishment may request in writing that the Authority decide on the matter. The authority shall decide on the proper classification of the medical device concerned, and its decision is final.

This amendment or second edition of MDA/GD/0009 will benefit the establishments with clear guidance on how to determine the classification of medical devices. In addition, it will allocate its medical device to an appropriate risk class. This can improve product classification and save time and money.

For more information: 

Click here  https://www.mda.gov.my/documents/guidance-documents/1978-mda-gd0009-classification-of-general-medical-device/file.html  for the full guidance on RULES OF CLASSIFICATION FOR GENERAL MEDICAL DEVICES by the MDA.

If you have any questions about medical device registration and representation in Malaysia, please contact us at sales@andamanmed.com

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