Medical Device Authority has issued a couple of advisory notices recently in an effort to keep the Covid-19 outbreak contained in the country. Previously, they had allowed for face masks to be imported into the country via a special access route, in order to alleviate out-of-stock situation. Now, they have issued a few more important advisories, as an attempt to control the impact of Covid-19 outbreak in the country.

1. MDA is also allowing for the importation, distribution and sales of personal protective equipment (PPE), which are used to prevent or reduce the risk of transmission and infection of germs to frontliners. These do not require approval from MDA, prior to importation into the country.

2. Secondly, in relation to COVID-19 Rapid Test Kits, MDA has also announced that the brand being advertised and sold online, by an establishment named MyEG is not approved by the Authorities. They have urged the public not to fall for these scams and has strongly rebuked the actions of MyEG. It is to be noted that unlawful advertisement and marketing of medical devices is a punishable offence, including at times like this, unless explicitly approved by MDA for unregistered sales.
3. On the other hand, MDA has publicly issued notice that WONDFO brand Rapid Test Kit are approved to be exempted from registration, via the Special Access route, to handle the widely spreading COVID-19 outbreak in the country. However, MDA has strongly reminded everyone that these rapid test kits are only for professional use and not for home-use. They have also reiterated that medical devices approved for sales in the country via the Special Access route must never be advertised directly to the public.

Reference:

1. Importation, distribution and sales of personal protective equipment (PPE)
2. Advertising and Sales of COVID-19 Rapid Test Kit Online
3. WONDFO Brand Test Kit Covid - 19 Exempted from Registration