On October 30, 2024, the Ministry of Health (MoH) of Indonesia introduced new requirements for the Medical Device Distributor License (IDAK). The aim of these changes is to improve standards within medical device companies and ensure accountability, in accordance with Ministerial Regulation No, 14/2021 on risk-based product licensing in the health sector.
The new requirements for the Medical Device Distributor License (IDAK) are as follows.
1) All medical devices distributors must have a technical responsible person.
2) The distributor and the technical responsible person must enter into a cooperation agreement in the form of a notarized contract.
3) The notarized cooperation agreement must specify the rights and obligations of each party, as well as the validity period of the agreement.
4) A socialization period (from October 1, 2024, to December 31, 2024) has been established through the Reglakes system(https://regalkes.kemkes.go.id/#home/berita/1000963) to inform all stakeholders about the new obligations and ensure compliance with the notarized agreement.
These requirements clearly define the rights and responsibilities of both distributors and technical responsible persons and they will come into effect on January 1, 2025.
For medical device distributors or technical responsible persons who are licensed in Indonesia, it is important to ensure that all necessary contracts and documentation are in place before the end of the socialization period.
Please refer to the attached document below.
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