Regulatory Affairs Update: Malaysia

Malaysia: Pilot Survey for Unique Device Identification (UDI)

On June 7th, MDA launched the first phase of the pilot survey for the implementation of Unique Device Identification (UDI) in Malaysia. The survey will be conducted in two phases, involving the following establishments and timelines (dates updated July 30 2024):

  1. Phase 1: Class D Medical Device Establishments – June 7, 2024, to August 15, 2024.
  2. Phase 2: Class B Medical Device Establishments – September 1, 2024, to October 30, 2024.

The purpose of this survey is to assess the readiness of medical device establishments in Malaysia to provide all required information regarding UDI for their registered products.

UDI is a unique numeric or alphanumeric code comprising a Device Identifier (DI) and a Production Identifier (PI), which serves to adequately identify medical devices sold in Malaysia from manufacturing through distribution to patient use.
The results of the survey will assist the Authority in deciding on the implementation timeline and updates to our MeDC@St 3.0+ system.

The timeline for UDI implementation is shown in the diagram below:

Proposed UDI Timeline (MDA)

Therefore, to ensure reliable data collection, MDA urges the mentioned establishments to give full cooperation in the pilot survey.

For further information can be found here.

If you have any queries about this draft guidance, please contact us at sales@andamanmed.com or click the button below.

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