During the COVID-19 pandemic, the Group has entered into the healthcare sector to bring in COVID-19 (SAR- CoV-2) RT-PCR and Antibody test kits from various manufacturing and distribution partners in Australia, China and South Korea to assist the Government in combating this pandemic. A total of 5 test kits were duly submitted to the Medical Devices Authority (“MDA”), a division of Ministry of Health (“MoH”), Malaysia under the Special Access Application through our appointed partner, Premier Diagnostics Sdn Bhd who possesses the MDA Establishment License and Good Distribution Practice for Medical Devices (GDPMD) License for importation and distribution. Following our announcement made on 13 November 2020, three (3) of the Novel Coronavirus (SAR-CoV-2) RT-PCR Detection and Diagnostic Kit have been duly assessed and received final decision by MDA, under the purview of MoH, and is now “Recommended for Use”. Further to the MDA final decision on three (3) of the Novel Coronavirus (SAR-CoV-2) RT-PCR Detection and Diagnostic Kit, the Company will enter into a contract with our partner, Premier Diagnostics Sdn Bhd for the importation, warehousing and logistic support. Meanwhile, the Company will work with other distributors who possess the MDA Establishment License and GDPMD License for distribution to the public and private pathology laboratory and hospitals as recommended by MoH. The Company had appointed MSK Medic Solution as our consultant for the application on MDA Establishment License and Good Distribution Practice for Medical Devices (GDPMD) License which will allow the Company to import and distribute the Novel Coronavirus (SAR-CoV-2) RT-PCR Detection and Diagnostic Kit directly.
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Posted by InvestorJ > 2020-11-27 20:51 | Report Abuse
During the COVID-19 pandemic, the Group has entered into the healthcare sector to bring in COVID-19 (SAR- CoV-2) RT-PCR and Antibody test kits from various manufacturing and distribution partners in Australia, China and South Korea to assist the Government in combating this pandemic.
A total of 5 test kits were duly submitted to the Medical Devices Authority (“MDA”), a division of Ministry of Health (“MoH”), Malaysia under the Special Access Application through our appointed partner, Premier Diagnostics Sdn Bhd who possesses the MDA Establishment License and Good Distribution Practice for Medical Devices (GDPMD) License for importation and distribution.
Following our announcement made on 13 November 2020, three (3) of the Novel Coronavirus (SAR-CoV-2) RT-PCR Detection and Diagnostic Kit have been duly assessed and received final decision by MDA, under the purview of MoH, and is now “Recommended for Use”.
Further to the MDA final decision on three (3) of the Novel Coronavirus (SAR-CoV-2) RT-PCR Detection and Diagnostic Kit, the Company will enter into a contract with our partner, Premier Diagnostics Sdn Bhd for the importation, warehousing and logistic support. Meanwhile, the Company will work with other distributors who possess the MDA Establishment License and GDPMD License for distribution to the public and private pathology laboratory and hospitals as recommended by MoH.
The Company had appointed MSK Medic Solution as our consultant for the application on MDA Establishment License and Good Distribution Practice for Medical Devices (GDPMD) License which will allow the Company to import and distribute the Novel Coronavirus (SAR-CoV-2) RT-PCR Detection and Diagnostic Kit directly.