Mah Sing Healthcare obtains MDR certification for glove sales in EU and EEA

KUALA LUMPUR (Dec 23): Mah Sing Group Bhd’s healthcare business unit Mah Sing Healthcare Sdn Bhd has obtained the Certificate of European Union Medical Device Regulation (EU-MDR) notification from its authorised representative Obelis European Authorized Representative Center (OEARC) that its nitrile examination gloves have fulfilled the relevant requirements of Regulation (EU) 2017/745.

In a statement filed with Bursa Malaysia on Thursday (Dec 23), Mah Sing Healthcare said the products — nitrile examination powder-free gloves (non-sterile) — may bear the CE marking and can be marketed in the European Union (EU) and European Economic Area (EEA) territories.

According to Mah Sing Healthcare, the MDR classification falls under the Class I-Devices that require completion of a technical file and self-declaration of the conformity of the products.

“With the recent issuance of FDA 510K, Health Canada Medical Device License, and now the Medical Device Regulation (MDR) certificate, Mah Sing Healthcare is ready to accelerate the export of medical-grade gloves to the United States, Canada, EU, and EEA territories,” the company said.

Mah Sing has completed the commissioning of all 12 production lines which are capable of producing 38,000 pieces of gloves per production line per hour, enabling a maximum production capacity of up to 3.68 billion pieces of gloves per annum.

Mah Sing’s share price settled down half a sen or 0.74% at 67.5 sen, bringing it a market capitalisation of RM1.64 billion.