“For product registration, Local Distributors and License Holders will need a GDPMD/CDAKB after July 1st, 2024.”

Ilham Hidayattulah
Principal Consultant
Asia Actual Indonesia

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Indonesia Implements GDPMD Requirement

Published on: May 16th, 2024

Back on April 30th, 2024, the Indonesian Ministry of Health (MoH) announced (Number FR.03.06/E.V/1095/2027) outlining a Good Distribution Practice of Medical Devices (GDPMD) certification requirement for all medical device importers and distributors. Known locally as Cara Distribusi Alat Kesehatan yang Baik (CDAKB) the new requirement is intended to “ensure the quality, safety, and efficacy of medical products, in accordance with the regulation PMK 14/2014 Clause 4, Article 2. I” and has been implemented in phases.

In 2020, GDPMD certification became a required element of all new Medical Device Distribution License (IDAK) applications. Companies with existing IDAK licenses will be subject to the GDPMD certification requirement upon renewal (valid for five years).

According to this new MoH announcement released on April 30th, starting on June 30, 2024, GDPMD certification of the local license holder will now be a required element of all new product registration (AKL) applications. Therefore, local distributors and License Holders must have obtained the GDPMD Certificate, or have proof of the submission’s progress, by July 1st, 2024 in order to register a product with the MoH.

While GDPMD certification is only required for companies within Indonesia and dealing with medical devices importation and sales, overseas manufacturers are advised to communicate closely with their local sales partners in Indonesia to ensure this new requirement will not interrupt or delay market access plans.

Come Grow With Us

Asia Actual has offices staffed by experienced, bilingual regulatory and commercial professionals in the major capital cities of Asia including Jakarta.  Contact Asia Actual to see how these changes may impact your business in Indonesia and to stay abreast of this dynamic situation.

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