Medical devices in Indonesia have long followed the Code of Federal Regulation or Regulation Number in US FDA. This includes various types of “Portable Liquid Oxygen Unit”.
Based on Decree of the Minister of Health of the Republic of Indonesia Number HK.01.07/MENKES/4745/2021, oxygen cylinder in Indonesia is determined as a medical device with product type “Portable Liquid Oxygen Unit”. However, in order to follow the harmonization of medical devices in ASEAN, empty oxygen cylinders are widely regulated as non-medical devices. On the other hand, oxygen gas which is sold separately is regulated as medicine.
In line with this, Indonesia’s Ministry of Health published Circular Letter Number: FR.03.01/5/0898/2021 issued on 17 July 2021 which decrees that oxygen cylinders that do not have thermally insulated containers and are designated for oxygen gas, are no longer considered medical devices. However, no information is provided as to how oxygen is regulated.
Products that do not meet the above criteria and have obtained Marketing Authorization License previously, can start to be circulated without a Marketing Authorization License and the license will be revoked by the Ministry of Health.