MDA Guideline on Registration of COVID-19 Test Kits
The Malaysian Medical Device Authority (MDA) released a new Guideline for the Registration of COVID-19 IVD Test Kits (MD/GL/07) on 24 January 2022. The guideline covers both the registration of COVID-19 test kits for those kits which have previously obtained Special Access Notification or Conditional Approval. It also covers registration for new COVID-19 test kits seeking marketing authorization in Malaysia.
As per the regulatory update we issued on Friday 28 January 2022, the MDA no longer accepts Special Access Notification or Conditional Approval applications as of today, 31 January 2022. All registrations must be submitted in full via the Medc@st system as of 1 February 2022.
The guideline provides two distinct scenarios for registration applications:
- Scenario A is applicable for COVID-19 test kits that have previously been approved by the MDA through Special Access Notification or Conditional Approval
- Scenario B is applicable for COVID-19 test kits that are not listed in the MDA portal and as such are considered as new applications.
Hence, an establishment should first identify the appropriate scenario and prepare the corresponding documentation before submitting their online application. Please note that Conformity Assessment Bodies are not required to conduct conformity assessments for the above mentioned test kits. However, the MDA has appointed Locally Assigned Evaluation Laboratories to verify the performance of COVID-19 test kits.
The main difference between the two scenarios is that test kits that have already been approved for distribution and sale in Malaysia (Scenario A) do not need to undergo performance testing. Hence applications under Scenario A have a shorter turnaround delay of 30 working days from receipt of a full application. Whereas applications submitted through Scenario B will be subject to additional evaluation time for performance testing of up to 90 working days, taking the total turnaround delay to 120 working days.
Risk classification, validity and fees
As stipulated in the guideline, the risk classification for all COVID-19 test kits is Class C, rule 3, and the validity of a successful full registration is five (5) years from the date of issuance.
As per the Fifth Schedule of the Medical Device Regulations 2012, the application fee for Class C IVD medical devices is RM500, in addition to the registration fee of RM2000.
The MDA will conduct a series of briefings to establishments starting 27 January 2022, as well as offer consultation slots through email@example.com
If you have any queries regarding the requirements for the supply of Covid-19 test kits or our services for medical device registration and representation in Malaysia, contact your Regulatory Affairs Specialist at Andaman Medical or click the button below.