Just two days ago, the Medical Device Authority (MDA) issued a statement in which they explained that MyEG has not been given the permission to distribute, sell or advertise their test kits. Even after the statement was issued, the test kits were still available for purchase on MyEG’s website. However, now, MyEG is providing a full refund for all the pre-ordered test kits as they wait for an exemption from the MDA.
To claim your refund, all you have to do is provide your invoice ID and IC/passport number at this link. The MDA elaborated in their statement that those who wish to get approval to market their COVID-19 test kits must do so via the authority’s special access registration method. In addition, any company or establishment that wishes to provide COVID-19 test kits must be registered and licensed to operate under the Medical Device Act 2012 (Act 737).
It is integral to note that once and if the test kits receive approval, they cannot be advertised and can only be distributed through approved healthcare premises. If anyone is caught committing an offence, they can be fined up to RM200,000 or sentenced to jail up to 2 years, or both under Section 5(2) Act 737, and fined not more than RM300,000 with imprisonment up to 2 years, or both under Section 44(2) under the same Medical Device Act.
Before announcing the issuance of refunds, MyEG had two kits that were available for purchase. A regular kit priced at RM99 and an advanced test kit priced at RM149. Previously, the health ministry had said that the test kits were in fact fake, however, that was retracted a few days later. MyEG had also claimed that they had received authorisation from the US FDA. MyEG said on their website that they will resume taking orders for the test kits once they receive approval.
