Guidelines for Implementation of Medical Device Regulatory System: Conditional Approval for COVID-19 Rapid Test Kid (Self-Test) made by the Medical Device Authority (MDA)

Guidelines for Implementation of Medical Device Regulatory System: Conditional Approval for COVID-19 Rapid Test Kid (Self-Test) made by the Medical Device Authority (MDA)
August 15, 2021 admin

Please be informed that the recent issued Guidelines for Implementation of Medical Device Regulatory System: Conditional Approval for COVID-19 Rapid Test Kid (Self-Test) made by the Medical Device Authority (MDA), provides, amongst others, the following:

(a) The COVID-19 RTK (self-test) kit … shall only be sold by registered Pharmacies and healthcare institutions registered with Cawangan Kawalan Amalan Perubatan Swasta (CKAPS); and

(b) Online sales are only allowed for registered pharmacies and health institutions …

In view of this and moving forward, we would like to inform you that we will only be able to sell our “Salixium” Covid-19 Rapid Antigen Test (“Product”) to bodies or corporations registered with CKAPS.

We would also like to prompt our customers that all open advertising activities in connection with the Product, whether online or offline, are strictly not allowed. This shall include, but does not limit to, self-made brochures, posters, online e-commerce platforms and social media platforms (including website, Facebook and Instagram). As such, we would appreciate that our customers dealing with the Product ensure that its marketing and sales activities adhere to the statutes, guidelines and/or regulatory requirements issued by the MDA, Ministry of Health and/or any other governing or regulatory body(ies) at all times.

RESZON DIAGNOSTICS INTERNATIONAL SDN BHD
14 August 2021