To ensure compliance with safety, quality, and efficacy standards as outlined in Government Regulation To comply with safety, quality, and efficacy standards outlined in Government Regulation Number 28 of 2024, the Indonesian Ministry of Health (Kemenkes) has announced important regulatory updates for distributing medical devices. Through Circular Letter No. HK.02.02/E/1753/2024, Kemenkes mandates that all local distributors obtain a Good Distribution Practices for Medical Devices (CDAKB) certificate. This certificate is essential for listing products in the sectoral e-Catalogue system.
Key Points from the Circular
- All medical device distributors must obtain a CDAKB certificate.
- The CDAKB certificate becomes mandatory for any product listed in the e-Catalogue system starting January 1, 2025.
Kemenkes encourages all stakeholders to comply with these regulations to maintain high standards in the production and distribution of medical devices throughout the country.
For details on applying for CDAKB certification, please visit: sertifikasialkes.kemkes.go.id.
