Indonesia: Substitution of Imported Medical Devices with Domestic Medical Devices in the sectoral e-Catalogue

Indonesia’s government through the Ministry of Health continues to support the usage of locally manufactured medical devices, especially the ones purchased via e-Catalogue by national hospitals. This campaign is stated under Instruction President No. 2-year 2022, which instructs the Ministry of Health to update the policies in accelerating and increasing the use of locally manufactured medical devices. The Ministry of Health responded to this instruction by issuing a Decree of the Minister of Health Number HK.01.07/MENKES/1258/2022 entitled “Substitution of Imported Medical Devices with Domestic Medical Devices in the sectoral e-Catalogue”, which was announced publicly to all Indonesian Distributors via socialization meeting on 28 July 2022.

The implementation of substitution of imported medical devices with domestic medical devices in the e-Catalogue is carried out by Freeze and Unfreeze mechanism. Details are outlined below:

Freeze Mechanism is implemented for Imported Medical Device if the following criteria are met:

1. Medical device products, that are suitable for the needs of health services, have been produced in Indonesia country and have obtained product approval licenses; and/or
2. The production capacity of medical devices has met the planned need for medical devices by product specifications that are appropriate for the needs of health services.

Unfreeze Mechanism is implemented for Imported Medical Devices if the following criteria are met:

1. If the national needs are not yet fulfilled by the production capacity of the domestic medical device industry, as evidenced by Medical Device Needs Document and Domestic Medical Device Production Capacity Data; and/or
2. Imported Medical devices will be unfreeze if their parameters and/or product specifications cannot be produced in Indonesia.

Every product that has been listed in the e-Catalogue which is affected by the Freeze Mechanism is unable to carry out transaction activities including receiving a purchase order from the hospital. Periodic studies will be conducted on imported medical devices that will be Freezed and Unfreezed, according to the criteria.

The implementation of the substitution of medical devices will be reviewed by the Substitution Team once a week based on the National Medical Devices Production Sufficiency Data Document prepared by the Directorate General of Pharmaceuticals and Medical Devices of the Ministry of Health.  The Substitution Team will issue freeze and unfreeze recommendations to the Bureau of Procurement of Goods and Services of Medical Devices.

If you have any queries regarding this announcement, please contact us.