The Indonesia Ministry of Health published an announcement on 11 May 2024, under Announcement No: FR.03.01/E/884/2024 about the Implementation of Cara Distribusi Alat Kesehatan yang Baik (CDAKB) Certification as the Requirement of Marketing Authorization for medical device distributions.
All medical device distributors and distributor branches carrying out any medical device distributions must apply for CDAKB certifications according to Article 2 of Health Ministerial Regulation No.4 / 2014.
The full enforcement of CDAKB certification as a requirement to apply for medical device permit approval license will be done by phase as below:
Socialization for implementing CDAKB certification will be effective from 1 May – 30 June 2024 through the Regalkes system.
The enforcement of CDAKB certification as marketing authorization requirement will be effective from 1 July 2024.
All medical device distributors may refer to the Sertifikasi KemKes for further information about the CDAKB certification application.
Source: Kementerian Kesehatan (KemKes)
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