Malaysia: MDA Withdrawn the Guidance Document: MDA/GD/0059 for COVID-19 RTK (SELF – TEST) – REQUIREMENTS
The Medical Device Authority of Malaysia (MDA) withdrawn the guidance document MDA/GD/0059 for COVID-19 RTK (SELF – TEST) – REQUIREMENTS from the MDA website on June 8, 2023. The guidance document was initially established and published with the intention to give specific requirements for conditional approval of Covid-19 RTK (self-test) to be placed in the Malaysian market, based on Circular Letter No.1/2021. The withdrawal information of this guidance document could be found in the list of Guidance Document under Medical Device Act 2012 (Act 737), that could be accessed here.
As COVID-19 RTK (SELF-TEST) registration is no longer applicable to go through Conditional Approval, it will follow the Guideline MDA/GL/07 Guideline for Registration of COVID 19 IVD Test Kits as this guideline serves as guidance for the following:
- Transition towards the submission of registration application of COVID-19 IVD test kits (Professional and Self-test) via Medc@st for all previous application that has obtained Special Access Notification or Conditional Approval
- New registration COVID-19 IVD test kits (Professional and Self-test) which have not obtained Special Access Notification or Conditional Approval previously.
If you have any queries regarding the withdrawal of the guidance document MDA/GD/0059 for COVID-19 RTK (SELF – TEST) – REQUIREMENTS from the MDA website, please contact us or click the button below.