Announcement

Based on Permenkes No. 62, 2017 concerning Marketing Authorization of Medical Devices, IVD Medical Devices, and Household health goods articles 1 and 2, and according to the Asean Medical Committee agreement, as well as the Rule of risk Classification in the Asean Medical Device Directive (AMDD), that Vaccine and Pharmaceutical products (medical) Storage / Refrigerator is not a medical device that must have a license approval from the ministry of health.

Refrigerator products that include medical devices are refrigerators intended for storage of blood and blood derivative products (Blood storage refrigerator and blood storage freezer).

Vaccine and Pharmaceutical (medical) Storage / Refrigerator products that still have a license approval are subject to freezing / revocation of the license, and subsequently these products can circulate without a license approval.