On May 07, 2024, the Indonesia Ministry of Health issued an Announcement Number FR.03.06/E.V/1095/2024 about the Implementation of the GDPMD Certificate (CDAKB: Cara Distribusi Alat Kesehatan yang Baik) as a Requirement for Marketing Authorization that was signed on 30th April 2024.
Based on the Regulation of the Minister of Health Number 4 of 2014 concerning GDPMD, Article 2, paragraph (1) states that every Medical Device Distributor and Medical Device Distributor Branch in carrying out distribution activities is required to apply CDAKB.
In connection with the regulation above, the Ministry of Health will apply the obligation of the GDPMD certificate as a condition in applying for a medical device permit approval license with the following stages:
Socialization for the implementation of GDPMD will be carried out from 1st May – 30th June 2024, through the registration system (Regalkes). The application of GDPMD certificate requirements in applications for medical devices approval licenses will take effect from 1st July 2024. More information about applying for GDPMD certification can be seen on this link.
For more information, please refer to this document.
If you have any queries about this draft guidance, please contact us at sales@andamanmed.com or click the button below.