• 2024-04-03 09:56:03

On January 23, 2024, Indonesia's Ministry of Health has published an announcement emphasizing the compliance with the latest regulations for medical device distributors. Existing IPAK (Izin Penyalur Alat Kesehatan) holders need to transition to IDAK (Izin Distributor Alat Kesehatan) as the updated Medical Device Distributor License through the Online Single Submission (OSS) website.

• 2024-03-01 08:09:48

With Indonesia currently strengthening their regulations on Telecommunication Equipment Testing and Certification (including telecommunication medical devices), a Decree from the Head of BBPPT No. 36/2024 has been published concerning the Guidelines for Testing Services conducted at BBPPT (en: Telecommunication Device Testing Center)

• 2024-01-26 06:28:31

Telecommunication technologies or devices in Indonesia, including telecommunication medical devices, should apply for Certificate of Telecommunication Device. In order to comply with this requirement at this moment, Indonesia MoH encourages manufacturer of medical devices with Bluetooth and RFID feature to voluntarily submit either Certificate of Telecommunication Device or Declaration Letter confirming the proposed product will apply for this certification during pre-market application.

• 2023-10-20 07:21:15

In September 2023, a circular letter issued by Indonesia’s Ministry of Health recommended that distributor license owners conduct post-market testing independently on circulated products. Products with submitted independent post-market test results which are within qualifications will receive a priority benefit in the e-Katalog system.

• 2023-09-27 07:23:16

Indonesia released a new Omnibus Health Law No. 17/2023, which was ratified on August 8, 2023, in the House of Representatives’ Plenary Session. The law discusses health regulations in general, including medical devices and healthcare.

• 2023-04-25 01:51:22

The Indonesia Ministry of Health issues circular letter no HK.02.02/E/359/2023 that regulates new requirements for the labelling of Rapid Diagnostic Antigen COVID-19 Nasal Swab Method with Self-Testing Claim.

• 2023-03-27 09:42:05

A Presidential Decree No. 6/2023 concerning Halal Certification for Drugs, Biological Products and Medical Devices, which is based on Government Regulation No 39/2021 concerning Halal Product Implementation, is issued. This decree will further regulate the halal implementation of medical devices in Indonesia.

• 2023-02-23 01:39:29

The Procurement Bureau of the Ministry of Health and the National Public Procurement Agency plan to expand E-purchasing access for private health facilities participating as National Health Insurance (in Indonesia known as JKN) providers for transactions of medical devices in the e-katalog starting from January 2023.

• 2022-12-27 07:40:22

Indonesia Halal Assurance Agency have issued Decree of Head of BPJPH Regulation Number 133 of 2022 concerning Procedures for Requesting Data Amendment on Halal Certificates. This regulation outlines the types of amendment allowed and the procedures for amendment application in Halal certificates.

• 2022-12-27 07:34:59

With the implementation of SATUSEHAT (the Indonesia Health System), the MoH are starting to build a Pharmaceutical and Medical Device Dictionary that will contribute to the interoperability between digital health apps and supply chain information of drugs and medical devices.