Frequently Asked Questions - Technical Evaluation
Face masks are regulated as medical devices if there are claims or descriptions by the manufacturer that makes the mask or respirator a medical device as defined in Section 2 of Act 737. Generally, face masks fall within this definition are intended for prevention of the transmission of disease (including uses related to COVID-19) and for medical purpose such as for surgical, clinical or use in other health services. The details information can be referred through guidance document on medical face masks and respirator- MDA/GD/0033.
The glove is classified as medical device if the intended can fit the definition of medical device in accordance with Section 2 of Act 737. Usually these are labelled as “surgical” or “examination” gloves.
It is in accordance with the intended use by the manufacturer and can fit the definition of medical device as stipulated in Section 2 of Act 737.