• 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.

• 2021-06-25 12:15:56

The Indonesian Ministry of Health announced that Approved Import Rapid Diagnostic Test of Antigen Covid-19 (RDT-Ag) which have not fulfil WHO Emergency Used Listing (EUL) recommendations, US-FDA Emergency Used Authorization (EUA) recommendations, or European Medicine Agency (EMA) recommendations and Approved Local Rapid Diagnostic Test of Antigen Covid-19 (RDT-Ag) which is not tested by Standard of National Institute of Health Research and Development of the Ministry of Health or an independent institution designated by the Ministry of Health are directed to conduct validation tests at laboratories that have been appointed by the Ministry of Health. This is stipulated on an announcement on February 15, 2021.

• 2021-05-22 06:38:30

The Indonesian government has issued regulation no. 39/2021 concerning the implementation of the halal product assurance sector. This will make medical devices containing animal derivatives expected to have halal certification with the following timeline: Class A is enforced starting on 17 October 2026, Class B is on 17 October 2029, and Class C is on 17 October 2034. While for Class D the implementation date hasn't been decided yet.

• 2021-05-22 05:31:34

The Indonesian Ministry of Health has issued guidance on reporting of Adverse Events (in Indonesia: Kejadian Tidak Diinginkan/ KTD). The guidance book explains the types of adverse events (KTD) that must be reported to the Ministry of Health and the reporting period.