Dear Medical Device Sector Stakeholders,

Greetings from the Medical Device Authority.

MDA announces an update on the UDI survey form for Class D establishments. The updated UDI survey form will be sent to the Class D establishments via the person in charge email as registered in MedC@St 2.0+.

With this update, MDA extends the timeline for both Phase 1 and Phase 2 pilot survey as follows:

Phase 1: Class D Medical Device Establishment – 7th of June 2024 until 15th of August 2024

Phase 2: Class B Medical Device Establishment – 1st of September 2024 until 30th of October 2024

The respective establishments are required to enable emails from official_announcement@mda.gov.my to receive updates and announcements from the Authority.

MDA would like to seek cooperation from the respective stakeholders for a comprehensive registration system.

For inquiries or assistance regarding the UDI pilot survey, please contact the following contact persons:

i) Puan Alya Jazmina at alyajazmina@mda.gov.my or 03 - 8230 0240.

ii) Puan Nashirah at nashira@mda.gov.my or 03-8230 0343.

Thank you.

Policy and Strategic Planning Division

Medical Device Authority

30 July 2024