covid19 test kit

MDA Announced Exemption of Conformity Assessment Process for the Registration of Covid-19 Test Kit

On June 13th 2022, the MDA has announced the exemption of conformity assessment process for registration of COVID-19 test kits either for personal or professional use via the Circular No.1/ 2022. The approval was decided during the MDA members meeting that was conducted on May 9th 2022. The implementation will be effective on the same day.

 

The Exemption of Conformity Assessment process will benefit all Establishments that would like to register the COVID-19 test kits in terms of time and cost for the product evaluation.

 

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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