Rubbed stamp 'revised'

Malaysia: MDA Released Second Edition Guidance Documents for Medical Gas System-Requirements for Registration

Malaysia’s Medical Device Authority (MDA) released a guidance document for the requirements of MEDICAL GAS SYSTEM – REQUIREMENTS FOR REGISTRATION. This guidance document will serve as a revised version of MDA/GD/0057 that was released in June 2020, which provides information on the requirements for registration of medical gas system “placed in market” as defined in Medical Device Act 2012. 

The revised guideline document covers the following matters:

  1. Revision on the Annex A (informative) Table: Medical Gas Sub-System and Related Individual/Specific Devices where the Medical Gas list of items for Distribution Sub-System, Patient Area Sub-System, Alarm Sub-System and Individual devices has been removed.
  2. Revision on the Annex B (normative) Table:  Classification of medical gas system where the Classification Rule has been revised accordingly by the MDA.

Further information on the released Second Edition Guidance Documents For Medical Gas System, please refer to this link.

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