A medical face mask is divided into two categories, namely procedure masks and surgical masks. Both are used in clinical and healthcare settings. The purpose of this guidance document is to define the requirements for both equipment types.
The purpose of this guideline is to clarify the use of medical face masks and respirators regulated under the Medical Device Act (Act 737). It applies to establishments, healthcare facilities, and the general public involved with medical face masks and respirators.
A face mask is a flexible, loose-fitting mask designed to be placed over the mouth and/or nose and chin fitted with the head harness which can be head or ears attachment of a wearer to permit normal breathing while protecting the wearer from the transfer of particles from the environment.
A respirator is a respiratory protective device designed to achieve a very close facial fit and very efficient filtration of airborne particles.
The registration of a medical device must be applied for in accordance with the requirements outlined in Act 737 and as determined by the Authority in the Medical Device Regulations 2012. The responsibility for registering a medical device under Act 737 lies with either the manufacturer or the authorized representative.
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