covid19 test kit

The Compliance Assessment Body (CAB) have Announced an Exemption to the Compliance Assessment Process for the Registration of Covid-19 Test Kits

On June 13th 2022, the Malaysian Medical Device Authority (MDA) announced that they have approved the exemption of conformity assessment process for registration of COVID-19 test kits either for personal or professional use through Circular No.1/ 2022 . 

 

The process was put forward by the Conformity Assessment Body (CAB).

 

The approval was decided during the MDA members meeting that was conducted on May 9th 2022. The implementation will be effective as of the same day.

The Exemption of Conformity Assessment process will benefit all establishments who would like to register the COVID-19 test kits in time for the product verification (PV) process, as well as the costs associated with it.

In addition, establishments wishing to register the COVID-19 test kit can refer to the relevant guideline document that has been provided on the MDA website, namely the Guideline for Registration of COVID-19 IVD Test Kits, MDA/GL/07. MDA/GL/07.

Download the guideline document from the MDA website here.  

Find further details of the announcement here.

If you have any queries regarding this announcement or our services for medical device registration and representation in Malaysia, please contact us at sales@andamanmed.com or click the button below.

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