Update on Medical Device Regulations in Indonesia
On January 10th, 2022, the Ministry of Health (MoH) in Indonesia officially implemented a notification scheme for certain class A medical devices within its REGALKES system, which is used for registering medical devices in the country. Previously, the MoH clarified that only specific class A medical devices that are home-use, non-sterile, and non-IVD were eligible for this scheme.
For details on the 34 class A medical devices and the related requirements, please refer here - #.
New Notification Menu on REGALKES
The Indonesia MoH has introduced a new menu for the notification scheme in REGALKES.