News
NMRA vigilant about face-mask quality
View(s):With information that face-masks worn properly may be one measure to help keep the virus away, people are seen sporting all kinds including masks matching their clothes.
As a video of face-masks being stitched not in the most hygienic of conditions went viral, the Sunday Times asked the National Medicines Regulatory Authority (NMRA) about the standards of these items which have become a necessity.
In the light of the emergency situation the country is facing, the NMRA’s Medical Device Regulatory Division has waived the usual registration processes under Section 109 of the NMRA Act for face-masks but is issuing Customs clearance letters to the importers on the provision of specific documents to ensure quality and safety. The documents required are the ISO Quality Management System Certificate of the manufacturer and the finished product test report/certification of analysis of the finished product which would be evidence that the product ensures microbial filtration, a source said.
“We ask for the packaging label (scanned outer box), invoice and letter of appointment from the manufacturer,” the source said that, explaining that the waiver is given only for a specific consignment. In some cases the importers voluntarily also produce CE Quality Assurance System Certificates and approvals given by the US FDA.
Under this division’s purview comes devices such as face-masks, N-95 masks, KN 95-masks, RT-PCR test-kits and medical equipment such as ventilators & analysers and personal protective equipment gowns and gloves.
Currently, 50 importers have brought in 5 million face-masks, while there are fewer than 10 local manufacturers who have been registered with the NMRA.
The source said that the NMRA is due to publish the list of those who have been approved for importation of face-masks on its website so that the public can check whether their masks are authorised or not.