Good Distribution Practice for Medical Devices (GDPMD) is a critical focus for the Ministry of Health (MoH) in regulating the distribution of medical devices in Indonesia. Initially, GDPMD compliance was required for medical device registration as of July 1, 2024. However, the MoH has allowed companies to fulfill this obligation by providing evidence of an ongoing GDPMP (Good Distribution Practice for Medical Devices) application.

At present, proof of a GDPMP application is no longer accepted as valid for medical device registration. This shift has led to a significant issue, as we have recently learned from our field team: the Ministry of Health is rejecting product registrations for companies that have been operating for more than 1-2 years without a valid GDPMD certificate. As a result, the GDPMD certificate is now mandatory, replacing the previous practice of submitting a GDPMD progress screenshot, which is no longer considered sufficient.

While the Ministry of Health has yet to officially announce the rejection policy regarding the lack of a GDPMD certificate, we are continuously monitoring the situation. We remain committed to providing up-to-date regulatory information from both official sources and practitioners in the field to ensure the stability of the medical device industry in Indonesia.

For information on new registrations, changes, and extensions related to GDPMD, please contact us.