Mah Sing Healthcare obtains MDR certification for the sale of gloves in the EU and EEA
KUALA LUMPUR: Mah Sing Group BhdMah Sing Healthcare Sdn Bhd Healthcare Business Unit has obtained European Union (EU) Medical Device Regulation (MDR) Certificate Notification to market its Nitrile Examination Gloves in the market of the EU and the European Economic Area (EEA).
In a dossier to Bursa Malaysia, the company stated that Mah Sing Healthcare’s MDR classification falls under the I-Devices class which requires the completion of a technical dossier and self-declaration of product conformity.
The product that has been stipulated in the authorizations is powder-free (non-sterile) nitrile examination gloves, he said.
“With the recent issuance of FDA 510K, Health Canada medical device license and now MDR certificate, Mah Sing Healthcare is ready to accelerate the export of medical grade gloves to the territories of the United States, Canada , the EU and the EEA, “he said. .
Mah Sing said that he has completed the commissioning of the 12 production lines and has already received many sales inquiries from customers.
These new high-speed glove dipping machines can produce 38,000 pieces of gloves per production line per hour, allowing a maximum production capacity of 3.68 billion pieces of gloves per year, he added. -Bernama