Based on Permenkes No. 62 of 2017 concerning Marketing Authorization for Medical Devices, IVD Medical Devices, and Household Health Goods, particularly articles 1 and 2, as well as the agreements made by the ASEAN Medical Committee and the rules regarding risk classification in the ASEAN Medical Device Directive (AMDD), it is clarified that Vaccine and Pharmaceutical Storage/Refrigerator products are not classified as medical devices and do not require license approval from the Ministry of Health.

It is important to note that refrigerators designed specifically for the storage of blood and blood derivative products, such as blood storage refrigerators and blood storage freezers, are considered medical devices and must comply with licensing requirements.

For Vaccine and Pharmaceutical Storage/Refrigerator products that currently possess license approval, please be aware that these licenses may be subject to freezing or revocation. Consequently, these products will be allowed to circulate without the need for license approval.