• 2025-08-25 03:07:39

Indonesia's Ministry of Health has issued Decision Letter No. HK.01.07/MENKES/736/2025, which outlines the types of medical devices that may be sold by retail business operators. This regulation clarifies the criteria that these devices must meet and the obligations that retailers must follow when engaging in the sale of medical device. It also provides a reference list of medical devices that are eligible for retail distribution under this policy.

• 2025-02-21 03:51:47

Indonesia's Ministry of Health has reclassified Filter Paper, specifically Dried Blood Spot (DBS) Filter Paper, as a Medical Device. This significant change, effective December 9, 2024, requires manufacturers to register their products as medical devices through the Online Single Submission (OSS) system. This reclassification necessitates compliance with specific regulations and quality standards, impacting product registration and market access in Indonesia.

• 2024-10-10 09:41:55

Indonesia is transforming its healthcare system through three major government projects: SIHREN, SOPHI, and INPULS. These initiatives aim to improve healthcare services, enhance access to specialized care, and strengthen the public laboratory system, addressing major diseases like cancer and heart disease. The projects also present significant opportunities for medical device manufacturers and regulatory consultants to align their offerings with Indonesia’s evolving healthcare needs.

• 2024-09-17 03:17:46

Indonesia's Ministry of Health has issued Regulation No. 3 Year 2024 as a new derivative to the previous halal regulations on medical devices, providing a more specific outline on the mandate for medical device halal certification. This regulation introduces stringent requirements for manufacturing, labeling, and material disclosure.

• 2024-06-19 06:08:37

The Indonesian Ministry of Health recently issued guidelines to regulate the use of Medical Devices and Household Health Supplies through electronic systems. These guidelines, signed on 5 April 2024, offer crucial information for business actors, manufacturers, and distributors in the healthcare sector seeking to market their products in electronic systems.

• 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.