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Malaysia Draft Medical Device Guidance on PERSONAL PROTECTIVE EQUIPMENT (PPE) - REQUIREMENTS

The Malaysian Medical Device Authority (MDA) drafted a guideline on personal protective equipment (PPE) and seeks feedback from the public, on the minimum performance and labeling requirements for personal protective equipment (PPE) before 25 March 2022. This guidance document is applicable to establishments, and healthcare facilities, dealing with PPE.

There are many types of Personal Protective Equipment (PPE) that are available in the Malaysian market that offer a range of protection against potential health hazards. A PPE are regulated as medical device if there are claims or descriptions by the manufacturer that makes the PPE a medical device as defined in Section 2 of Act 737.


If the manufacturer's labeling, advertising, or documentation contain the claims above, the PPE is considered to be a medical device and is required to be registered with the Authority.


Non-medical PPE such as those used in construction and other industrial applications are not regulated by MDA. This guidance document is will provide useful information on medical PPE to establishments, healthcare facilities, and the public dealing with PPE.


According to the guidance, PPE registration for class A, does not require an assessment from a Conformity Assessment Body, but, for registration purposes the establishment must provide the complete test report to the Authority during registration.


For more detailed information on click this LINK

Additionally, Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) has updated its guidance on "Guidance and Requirements on Conditional Registration of Pharmaceutical Products During Disaster" the requirements for conditional registration of pharmaceutical products during disasters.


Click this LINK to know more on the updates related to the post-registration section of crisis authorization guidance.

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