On July 6, 2022, the Ministry of Health of the Republic of Indonesia issued a Decree of the Minister of Health (KMK)   RI Number HK.01.07/Menkes/1258/2022 concerning the Substitution of Imported Medical Devices with Domestic Medical Devices in the Health Sector E-Catalog.. And on July 28, 2022, the Ministry of Health of the Republic of Indonesia invited members of GAKESLAB Indonesia, the Association of Indonesian Medical Device Manufacturers (ASPAKI), the Association of Indonesian Medical Gas Installations (AIGMI), members of the Association of Indonesian Optical Entrepreneurs (Gapopin), and Leaders of Medical Device Businesses to participate in the socialization of KMK RI Number HK.01.07/Menkes/1258/2022 concerning the Substitution of Imported Medical Devices with Domestic Medical Devices in the Health Sector E-Catalog..

In the letter, it was noted that the aim is to increase health resilience and the growth of the domestic medical device industry. It is necessary to prioritize the use of domestic medical devices in the implementation of government policies through the Health Sector E-Catalog. You can choose from a variety of local medical devices in the health sector E-Catalog, therefore it is important to decide how to replace the medical equipment manager with local medical equipment. A decree from the minister of health is required in order to replace imported medical devices in the Health Sector E-Catalog with domestic medical devices.

MEKANISME FREEZE DAN UNFREEZE

Substitution of imported medical devices with domestic medical devices in the Health Sector E-Catalog is carried out using Freeze dan UnFreeze. There are several benchmarks for carrying out the Freeze dan UnFreeze.

• Mekanisme Freeze will be carried out if the medical device product that is suitable for the needs of health services has been produced domestically and has a distribution permit and/or the production capacity of the medical device has fulfilled the plan for the need for medical devices with product specifications that are suitable for the needs of health services.
• Mekanisme UnFreeze will be carried out on imported products if national needs have not been met by the production capacity of the domestic medical device industry, as evidenced by the Medical Device Needs Document and Domestic Medical Device Production Capacity Data.

For imported products that were already in the E-Catalog prior to the issuance date of the RI KMK Number HK.01.07/Menkes/1258/2022, namely July 6, 2022, they will not be frozen and vice versa. The products that are already in the E-Catalog after log prior to the issuance date of the RI KMK Number HK.01.07/Menkes/1258/2022, namely July 6, 2022, they will not be frozen and vice versa. The products that are already in the E-Catalog after July 6–31, 2022, Freeze dan UnFreeze will be quarantined with Freeze and UnFreeze results, which are likely to be issued in the first week of August.

the substitution was carried out by forming a team involving officials from the Ministry of Health. Substitution will be reviewed periodically every week on imported medical devices that will be freeze dan unfreeze, sesuai dengan kriteria. Alat kesehatan yang telah dilakukan ubstitusi akan dilakukan evaluasi pada E-Catalog sektoral kesehatan.

There are several product parameter criteria that cannot be met in Indonesia, including :

• Steam Sterillizer dengan Spesifikasi Chamber > 50 Liter
• Electrocardiograph (ECG) dengan spesfikasi parameter ≥ 8 chanel
• Cardiac monitor (termasuk cardiotachometer dan alarm tingkat) dengan spesifikasi parameter ≥ 5 chanel 
• Patient examination glove dengan bahan Nitril
• Manual surgical instrument dan obgyn manual general instrument dengan spesifikasi dan ditujukan untuk tindakan khusus, seperti biopsy, IUD, dan sebagainya 
• Glucose test system – Strip tes glukosa sistem tertutup