• 2022-04-27 11:19:24

The process and duration of the notification scheme for certain class A medical devices compared to the regular class A medical devices registration.

• 2022-03-25 11:13:53

The Indonesia Halal Assurance Agency has published the Ministry of Religion Decree No.1360/2021 on the Materials Exempted from the Obligation of Halal Certification on their official website. The regulation contains an extensive list of materials exempted and serves as guidance for the regulatory bodies.

• 2022-03-25 10:41:47

Indonesia's MoH has announced the integration of their licensing system: REGALKES with OSS RBA (Online Single Submission Risk-Based Approach) for new applications of marketing permit and their plans on integrating more licensing services with OSS RBA.

• 2022-03-25 10:38:56

Starting from February 2022, the Indonesia Ministry of Health is accepting product listing of medical devices and other health equipment for their sectoral e-catalogue for health facilities.

• 2022-02-18 08:22:55

Indonesia MoH has officially implemented a notification scheme for certain class A medical devices in the REGALKES system since 10th January 2022.

• 2022-01-26 08:44:48

Indonesia Halal Product Assurance Agency (BPJPH) has announced fix service rates related to Halal Certification according to the Decree of Head of BPJPH Regulation Number 141 of 2021, which have been implemented since 1st December 2021.

• 2021-09-29 00:09:37

Back in July 2021, Indonesia’s Ministry of Health announced that oxygen cylinders that do not have thermally insulated containers and are not designated for oxygen gas, are no longer to be considered as medical devices.

• 2021-08-26 11:43:03

Indonesia’s Ministry of Health has introduced simplified routes for certain class A medical devices. The characteristics of certain class A medical devices themselves are Home Use, Non-Sterile, and non-IVD. The products which can be registered through a simplified route will need fewer documentation requirements compared to the regular registration route.

• 2021-08-01 16:18:48

The Ministry of Finance has issued a new regulation on Tariffs for the Public Service Halal Products Certification Agency at the Ministry of Religion. It regulates the price range for halal certification that will be applied to goods circulated in Indonesia such as medical devices containing animal derivatives.

• 2021-08-01 16:05:20

The Indonesian Ministry of Health has issued new guidance on Withdrawal and Destruction of Non- Conformity Medical Devices. It describes the types, criteria, roles and responsibilities, classifications, and procedures for withdrawing medical devices from circulation. It is hoped to assist manufacturers, importers, and distributors in better managing post-market activities such as the withdrawal of medical devices in Indonesia.