The Ministry of Health (MoH) of Indonesia has announced a significant regulatory update affecting the medical device distribution sector. Through Circular Letter No. HK.02.02/E/1753/2024, the Ministry has mandated that all local distributors must obtain Good Distribution Practice for Medical Devices (GDPMD) certification to be eligible for enrolment in the sectoral E-catalogue. This new requirement is set to be enforced starting January 1, 2025.

The circular letter, officially released and available on the MoH’s portal dedicated to the licensing of production facilities and distribution of medical devices, underscores the government's commitment to enhancing the safety and quality of medical device distribution within Indonesia. The full announcement can be accessed Here.

Key Points of the Circular Letter:

1. GDPMD Certification Requirement: GDPMD Certification Requirement: All local distributors of medical devices must hold a valid GDPMD certification. This certification is crucial for ensuring that distributors adhere to recognized standards for the safe and effective distribution of medical devices.
2. E-Catalogue Enrolment: Distributors without GDPMD certification will not be eligible to enroll in the E-catalogue. The E-catalogue is a vital platform for procurement, providing a comprehensive list of medical devices available for purchase by healthcare facilities across Indonesia.
3. Implementation Timeline: The new certification requirement will come into effect at the beginning of 2025, giving distributors several months to comply with the new regulations.
4. Enhanced Oversight and Compliance: This move aims to strengthen regulatory oversight and ensure that all medical devices distributed within the country meet stringent quality and safety standards.
5. Access to Resources: The Ministry of Health has made information regarding GDPMD certification and the enrolment process available on their licensing portal. Distributors are encouraged to review the details and begin the certification process well in advance of the implementation date.

This regulatory change reflects the Ministry’s ongoing efforts to align with global best practices and improve the overall standards of medical device distribution in Indonesia. By requiring GDPMD certification, the MoH aims to ensure that all local distributors are equipped to manage the complexities of medical device distribution, thereby enhancing patient safety and product quality.

For further details, updates, and queries related to GDPMD certification and E-catalogue enrolment.