Indonesia: Mandatory GDP Certification for Medical Devices in the e-Katalog (w.e.f 1 January 2025)

The Ministry of Health of the Republic of Indonesia released a circular no. HK.02.02/E/1753/2024 to address the implementation of the Good Distribution Practise (GDP) Certificate for medical devices as a requirement in the electronic catalog system (e-Katalog).

To ensure the safety, quality, and efficacy of medical devices following Government Regulation No.28 of 2024, which implements Law No.17 of 2023 on Health, the following key points are communicated:

• All medical device distributors must obtain a GDP certificate for medical devices.

• With effect from 1 January 2025, the GDP certificate for medical devices will be a mandatory requirement for listing products in the e-Katalog

  
  

This regulation aims to strengthen oversight and ensure that all medical devices meet the necessary standards for safety and quality before being distributed to the market. By implementing the GDPMD certification, the government seeks to enhance the overall accountability of medical device distribution, protecting both healthcare providers and patients.

Source: Directorate General of Pharmaceuticals and Medical Devices (KemenKes)