ANNOUNCEMENT

 MEDICAL DEVICE AUTHORITY (MDA) CIRCULAR LETTER NO. 1/2026 PROCUREMENT OF MEDICAL DEVICE FOR HEALTHCARE FACILITY INSTITUTIONS

 MDA wishes to inform that the policy establishment for implementation and enforcement under Act 737 regarding the procurement of medical devices for healthcare facility institutions has been approved. This is in accordance with the decision made during the MDA Authority Meeting No. 1/2026, and the enforcement of this policy is enacted through Circular Letter No. 1/2026, which is effective as of 28 January 2026.

 Through the enforcement of this Circular Letter No. 1/2026, the medical device procurement procedures for healthcare facility institutions are as follows:

  • Any company or supplier representative participating and succeeding in tender procurement activities (tenderer) is classified as an establishment under the interpretation of Section 2, Act 737. The activity of supplying medical devices through tender is included in the activity of "placing in the market".
  • Subsequently, in accordance with the provisions of Section 15(1), Act 737, all tenderers are mandated to:
    • Posseses a valid establishment license to conduct distribution activities;
    • Implement a quality management system based on Good Distribution Practice for Medical Devices (GDPMD);
    • Bear full post-market responsibility, including incident reporting to the MDA, complaint investigation, and the implementation of field corrective actions or product recalls if necessary.
  • To ensure legal compliance and patient safety, Healthcare Facility Institutions (Public and Private Sectors) must ensure that the following documents are obtained from the tenderer before procurement is finalized:
  • A copy of the establishment license as a medical device distributor (in the name of the tenderer).
  • A copy of the valid medical device registration certificate for the relevant product.
  • A letter of appointment as a distributor from the Authorized Representative (AR) or the original establishment.

With the issuance of this Circular Letter, Circular Letter No. 2/2016 (Revision 2) is hereby revoked.

Circular Letter No. 1/2026 can be downloaded from the MDA website and via the following link: CLICK HERE.

Thank you.

Chief Executive

Medical Device Authority

28 January 2026