Malaysia issues guidance on medical face masks
Last week the Medical Device Authority (MDA) in Malaysia released a new guidance document on face masks and respirators for medical use. The guidance covers performance characteristics, labelling and registration requirements.
According to the World Health Organisation (WHO), medical face masks are divided into two categories: procedure masks and surgical masks, both of which are used in clinical/health care settings. There are many types of masks that are available in the Malaysian market that offer a range of protection against potential health hazards. Face masks and respirators are regulated as medical devices if there are claims or descriptions by the manufacturer that make the mask or respirator a medical device as defined in Section 2 of Act 737.
This guidance document specifies the requirements for medical face masks and medical respirators. The person responsible for registering a medical device under Act 737 is the manufacturer or the authorized representative. The MDA lists two types of medical face mask/respirator that are regulated under the Medical Device Act:
- Procedure mask/respirator
- Description: A procedure mask is used for performing patient procedures, or when patients are in isolation (Clean environments, sterile cores, processing departments, ER and ICU for bedside procedures, etc.) to reduce the risk of spread of infections.
- Surgical mask/respirator – Fluid resistant
- Description: A surgical mask is used inside the operating room or within other sterile procedure areas to protect the patient environment from contamination. It is also intended to protect the wearer against splashes of potentially contaminated liquids.
The face masks or respirators listed above shall comply to specific requirements on performance and labelling as listed by the MDA prior to their registration. These requirements include:
- Barrier Testing (BFE%, PFE%, Synthetic Blood)
- Physical Testing (Differential Pressure)
- Safety Testing (Flammability, Microbial Cleanliness, Biocompatibility)
- ‘Requirements for Labelling of Medical Devices’ published by the MDA in November 2018.
Also available in the Malaysia market are non-medical face masks and non-medical respirators. Nonmedical face masks are marketed to the general public for general use, i.e. non-medical purposes, are not considered medical devices. A non-medical respirator is a respiratory protective device designed to achieve a very close facial fit and very efficient filtration of airborne particles. These non-medical respirators intended for use in industrial settings such as construction sites or factories to protect workers from dust and debris. Both non-medical face mask and non-medical respirators are classified as personal protective equipment (PPE) and are not regulated by the MDA, i.e., are not concerned by this guidance document.
Click here for the full guidance document from the MDA on the regulations for face masks / respirators.
If you have any queries regarding updates published by the MDA, labelling requirements for medical devices or our services for medical device registration and representation in Malaysia, please send us an email to firstname.lastname@example.org