Based on Ministry of Health’s Announcement No. UM.01.05 / 5/0050/2021 issued on January 19, it is explained that Vaccine and Pharmaceutical (medical) Storage / Refrigerator products are no longer considered medical devices in Indonesia.
This decision was taken based on Regulation of The Minister of Health of The Republic of Indonesia
Number 62 of 2017 concerning Product License of Medical Devices, In Vitro Diagnostic Medical Devices and Household Health Products Articles 1 and 2, and in accordance with the agreement of the ASEAN Medical Device Committee and the Rule of Risk Classification in the ASEAN Medical Device Directive (AMDD).
With those policy, the Indonesia Ministry of Health will take the following actions:
- 1. Marketing Authorization Certificate for Vaccine and Pharmaceutical (medical) Storage / Refrigerator Products circulated in Indonesia will be revoked.
- 2. Henceforth, Vaccine and Pharmaceutical (medical) storage / refrigerator products can be circulated without having Medical Device Marketing Authorization Certificate from Indonesia Ministry of Health.
Refrigerator which still included as medical device in Indonesia is Blood Storage Refrigerator and Blood Storage Freezer.
Reference:
Vaccine and Pharmaceutical (medical) Storage / Refrigerator announcements