Following the President’s instruction to prioritize the use of domestic products in government procurement of goods/ services, Indonesia’s Ministry of Health has issued Ministry of Health Decree Number HK.01.07/MENKES/1258/2022 concerning Substitution of Imported Medical Devices with Domestic Medical Device in the Electronic Catalog/e-Katalog of the Health Sector. Effective since 6th July 2022, the decree regulates substitution of imported medical devices by “freeze” and “unfreeze” mechanism in the health sectoral e-k=Katalog.
All Imported medical devices, which have just been listed in the health sectoral e-katalog, will be subjected into “freeze” state first and the medical device will have weekly/periodically quarantine (temporarily freeze) for evaluation. Indonesia’s Ministry of Health will evaluate by checking Production Capacity Data Documents and National Medical Device Production Adequacy Data Documents. The following are the criteria for freeze/unfreeze mechanisms implemented for evaluation:
a. Freeze (the medical device won’t be shown in the E-Katalog)
1. Medical device products that are suitable for the needs of health services have been produced domestically and have a distribution permit.
2. The production capacity of medical devices has met the planned need for medical devices with product specifications that are suitable for the needs of health services
b. Unfreeze (the medical device shows in the E-Katalog)
1. Imported medical devices can be unfreeze again if the national needs have not been met by the production capacity of the domestic medical device industry, as evidenced by documents on the need for medical devices and data on the production capacity of domestic medical devices.
2. Medical devices that have been unfreeze must have parameters and/or product specifications that cannot be produced in Indonesia.
If the condition of “unfreeze” state are met, imported medical device will “unfreeze” and show in E-Katalog website system.