by LYDIA NATHAN / pic by BLOOMBERG
MORE personal protective equipment (PPE) manufacturers are seeking to get certified to gain market access to developed markets like the US and Europe.
Komarkcorp Bhd’s subsidiary, Komark Mask (M) Sdn Bhd, was awarded a certification by Medical Device Authority Malaysia to manufacture disposable medical equipment, specifically face masks and PPE.
In a filing to Bursa Malaysia yesterday, Komarkcorp reported that the certification shows the group is in compliance with local medical authorities to manufacture disposable medical devices for medical usage.
Its group CEO Koh Chie Jooi said it intends to manufacture masks that are of the highest possible standard for local and export consumption.
“Komarkcorp has already begun its applications for Food and Drug Authority (FDA) certification and Respirator Precertification (NIOSH) from Nelson Labs in the US, as well as Conformitè Europëenne (CE) mark in Europe.
“The group will update the market accordingly as each certification gets approved,” he said.
This comes as Komarkcorp announces plans to instal up to 30 face masks production lines within the next 24 months, particularly three-ply surgical face masks and KN95 masks with a targeted annual production capacity of up to 522 million three-ply surgical face masks and 120 million KN95 face masks.
Meanwhile, Notion VTec Bhd’s unit, Notion Venture Sdn Bhd, was granted a Certificate of Registration (CoR) from Registrar Corp confirming its registration with the US FDA for financial year 2021 for the polymer patient examination glove.
Notion VTec noted that it will need a 510(k), a premarket submission to the FDA, demonstrating the device is safe to be marketed.
The company said it has submitted the necessary documents to apply for the CE marking certification for the nitrile gloves from the European Union (EU), and the approval is expected to be obtained soon.
“Both certifications are necessary for marketing the nitrile gloves in the US and Europe, in which the company’s nitrile gloves are currently supplied by original equipment manufacturers, and brand building of the ‘Novid’ brand will be taking place before the company’s gloves production starts in the middle of 2021,” it said.
Prolexus Bhd’s wholly owned subsidiary, Honsin Apparel Sdn Bhd, obtained a CoR from Registrar Corp, which certifies that it has registered with the US FDA for face masks.
In a filing to Bursa Malaysia yesterday, Prolexus said this does not include the N95 respirator, while adding that the registration of CE marking with the EU is still in progress.