IMPLEMENTATION OF MEDICAL DEVICE AUTHORITY (PBPP) CIRCULAR NO. 1 OF 2026

The Medical Device Authority (MDA) wishes to inform that Circular Letter of Medical Device Authority No. 1 Year 2026 has come into full effect on 28 January 2026.

However, in order to ensure the smooth administration of government and private procurement activities, as well as the continuity of ongoing medical device supply, an exemption from the implementation of this circular is granted to tenderers falling under the following categories:

  • Category I: Tenderers who are currently supplying medical devices under tenders awarded prior to 28 January 2026;
  • Category II: Tenderers who have received a Letter of Acceptance (LOA) or Tender Award prior to 28 January 2026; and
  • Category III: Tenderers who have participated in tender processes arising from tender advertisements issued prior to 28 January 2026.

This exemption is granted and shall apply only until:

  • The expiry of the existing contract period; or
  • The completion of the relevant tender activity.

Pursuant to Section 15 of the Medical Device Act 2012 [Act 737], it is COMPULSORY for all tenderers to possess a valid Establishment Licence prior to participating in any new tender or subsequent tender activities. In addition, tenderers must comply with all licensing requirements stipulated under the Medical Device Regulations 2012 and Circular Letter of MDA No. 1/2026.

Industry stakeholders are reminded that failure to comply with these requirements constitutes an offence under Section 15 of Act 737 which is currently in force. Any party found to be non-compliant may be subject to legal action by the MDA.

Further information or the full text of the Circular Letter may be obtained through our official portal at www.mda.gov.my. Any inquiries regarding this implementation may be directed to the Industry Facilitation Unit via email at ebantuan@mda.gov.my.

 “ENSURING THE QUALITY AND SAFETY OF MEDICAL DEVICES”

Chief Executive
Medical Device Authority (MDA)
Ministry of Health Malaysia

5 March 2026