Regulatory Affairs Update: Indonesia

Indonesia: GDPMD Certificate as Mandatory Requirement for e-Catalogue Listing

The General Director of Pharmacy and Medical Devices signed a circular letter No. HK.02.02/E/1753/2024 on 09 September 2024, regarding the implementation of the Good Distribution Practice of Medical Device (GDPMD) Certificate as a mandatory requirement for listing in the e-Catalogue system. The circular letter highlights the following information:

1. Every medical device distributor is required to have a GDPMD certificate.
2. The GDPMD certificate has become mandatory for products to be displayed or listed in the e-Catalogue system. This will be effective starting January 01, 2025. The circular letter can be accessed here (in Bahasa Indonesia, no English translation is available).

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