KUALA LUMPUR, June 19 — Key Alliance Group Bhd has obtained first stage approval to be legally allowed to market, distribute and sell the Care Gene Covid-19 Polymerase Chain Reaction (PCR) Test Kits manufactured by Well Bio Inc, Korea.
In a statement today, Key Alliance said it had received official notification from Conformity Assessment Bodies (CAB) Malaysia that its wholly-owned subsidiary, Key Alliance Sdn Bhd (KASB), has passed the initial audit and been issued the Good Distribution Practice for Medical Devices (GDPMD) Certificate of Conformity.
This allows KASB to act as a local authorised representative, import, storage and handling, warehousing and documentation of medical devices, specifically in vitro diagnostic devices.
CAB is an approved certification body by Medical Devices Authority, which is part of the Health Ministry.
“The next immediate step is for KASB to submit for the Medical Device Authority (MDA) Establishment Licence, which will ensure that the company is in full compliance with the Ministry of Health and the MDA’s requirements for a company to be a licensed distributor of medical supplies.
“Consecutively and immediately after, KASB will submit its product, Care Gene Covid-19 PCR Test Kit, to the MDA for Special Access Approval, which will then allow this test kit to be legally marketed and sold in Malaysia,” Key Alliance said.
It said with the second wave of Covid-19 infections already spreading in Beijing, there is a foreseeable need for regular stockpiles of PCR Test Kits, which the Malaysian government has deemed to be the preferred testing method, as opposed to Antibody or Antigen Rapid Test Kits.
The global PCR and real-time PCR testing market is expected to grow from US$7.5 billion (RM32 billion) in 2019 to about US$22.4 billion in 2020.
The market is expected to stabilise and reach US$10.1 billion at a compound annual growth rate of 7.9 per cent through 2023. — Bernama