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The Ministry of Health of Indonesia has introduced new guidelines for medical device distributors to enhance regulatory compliance, effective from 1 January 2025. This latest update aims to improve standards and ensure proper accountability within the industry, as outlined in the Ministerial Regulation No.14/2021 on Risk-Based Product Licensing for Health Sector Activities.
What’s New?
Hence, to maintain and enhance the standards in the medical device distribution sector, MOH now requires distributors to fulfill several key conditions as below:
Each medical device distributor must have a qualified full-time technical manager responsible for overseeing compliance and maintaining operational standards.
Distributors and their technical managers must sign a Notarial Agreement, which will serve as a binding document specifying both parties' responsibilities, rights, and obligations and the effective date of the contract, ensuring transparency and accountability.
Between 1 October and 31 December 2024, socialization efforts for the Notarial Agreement requirement will be conducted via the Regalkes system to inform all stakeholders about these new obligations. During this period, distributors will be provided with detailed information to understand and implement.
Implications for the Industry
This initiative highlights Indonesia’s commitment to raising standards in medical device distribution, ensuring that distributors are equipped with dedicated personnel and clearly defined responsibilities. By introducing a full-time technical manager and a formalized agreement, the Ministry aims to ensure that distributors maintain high operational standards, thereby safeguarding public health.
Next Steps
Distributors are urged to review these requirements and ensure compliance within the stipulated timeline to avoid any disruptions to their licensing status.
For more information, you are welcome to refer to the official Kementerian Kesehatan (Kemenkes).
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