Malaysia: Personal Protective Equipment (PPE) – Requirements

Medical Device Authority (Malaysia) has published a guidance document on Personal Protective Equipment (PPE) requirements to help the industry and healthcare professionals in their quest to comply with the Medical Device Act 2012 (Act 737) and the regulations under it.

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 devices if there are claims or descriptions by the manufacturer that makes the PPE a medical device as defined in Section 2 of Act 737. Non-medical PPE such as those used in construction and other industrial applications are not regulated by MDA.

An application for the registration of a medical device shall be made according to the requirements in Act 737 and in the manner determined by the Authority in Medical Device Regulations 2012. The person responsible for registering a medical device under Act 737 is the manufacturer or an authorized representative. All PPE listed in table 1 in the guidance documents, is classified as a medical device if the intended use can fit the definition in Section 2 of Act 737.

For class A PPE registration does not require an assessment from the CAB. However, for the purpose of registration, an establishment shall submit the complete test report to the Authority during the registration process.

Sources:

Personal Protective Equipment (PPE) – Requirements Guidance Document

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