The Medical Devices Authority (MDA) of Malaysia is aware of the Coronavirus (Covid-19) infection outbreak in Malaysia and around the world. Subsequently, the World Health Organization (WHO) and the Ministry of Health have encouraged the use of face masks (including surgical masks) as a precautionary measure against this infection.
These face masks, which are traditionally used to prevent infections between patients and healthcare workers, are considered as medical devices in Malaysia. Hence, they must be registered under the Medical Devices Act 2012 (Act 737), to ensure Safety and efficacy, before being placed in the market.
However, to ensure that continuous access to these face masks is not disrupted during the Covid-19 outbreak, any company or establishment may apply for a Notification of Exemption from Registration of Medical Devices for appropriate face masks placements in the market, through a Special Access route.
Face masks imported under this special access notification would follow Route B, as specified in the Guidance Document MDA/GD/0043 Notification of Medical Device for Special Access. They must have obtained prior approval in any one of the five MDA-recognized countries and may be placed in the market, once receiving the Acknowledgement on Notification from MDA. Each application costs RM300. Further details can be consulted in the Guidance Document MDA/GD/0043 Notification of Medical Device for Special Access.
Manufacturers are expected to ensure that the masks have undergone necessary safety and performance tests. Most importantly, any face masks that have obtained clearance under this Exemption Notification, SHALL NOT BE ALLOWED TO BE ADVERTISED AT ALL (including on online shopping platforms) and sales should be made directly to authorized health premises or pharmacies.
MDA is constantly monitoring the advertising, distribution and sales of face masks in the market, including their sales and distribution through online shopping platforms like Lazada, Shoppee and others to ensure safe face masks availability in the market. The public is advised to only use face masks, which are registered/ notified with the MDA to protect and prevent the further spread of COVID-19. Status of these face masks’ registration can be checked by visiting https://mmdr.mda.gov.my/public/index.php or by contacting the Authority at 03-882300300 or by emailing to [email protected].
- MDA Announcement: PENGEDARAN PENUTUP MULUT DAN HIDUNG SEMASA PENULARAN WABAK PENYAKIT AKIBAT JANGKITAN NOVEL CORONAVIRUS 2019 (COVID 19)
- Guidance Document MDA/GD/0043 Notification of Medical Device for Special Access