On October 30, 2024, the Director of Medical Device Production and Distribution in Indonesia issued Notification Letter No. FR.03.06/E.V/1905/2024, outlining new requirements for fulfilling the Medical Device Distributor License (IDAK). This letter introduces key conditions that distributors must meet to maintain compliance under the new regulations. You can access the official notification letter in Indonesian here Notary-Deed-of-Cooperation-Agreement-between-TRP-and-the-Company-as-a-Requirement-for-IDAK.
Key Requirements:
- Technical Responsible Person (TRP): Each medical device distributor must employ a Technical Responsible Person (TRP) who meets full-time employment requirements.
- Notary Deed of Cooperation Agreement: The distributor and the TRP are required to formalise their engagement through a Notary Deed of Cooperation Agreement, ensuring the following:
- Rights and Obligations: Clear definition of each party’s rights and responsibilities.
- Contract Validity Period: A stipulated period of validity for the contract.
Socialisation Period for Compliance:
The Ministry of Health (MoH) has scheduled a socialisation period from October 1 to December 31, 2024, to facilitate the implementation of the Notary Deed of Cooperation Agreement between the TRP and the distributor. This guidance will be accessible through the MoH registration system (regalkes.kemkes.go.id).
Effective Date:
These new requirements will come into effect on January 1, 2025.
Next Steps:
If you are a licensed medical device distributor or a TRP, ensure that the necessary agreements and documentation are completed by the end of the socialisation period.
Should you have any inquiries or require further assistance, please do not hesitate to contact us at sales@andamanmed.com or click the button below.