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INDONESIA: Testing and Certification for Telecommunication Medical Devices –January/February 2024

INDONESIA: Testing and Certification for Telecommunication Medical Devices –January/February 2024

  • 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.

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INDONESIA: POST MARKET TESTING OF MEDICAL DEVICES – OCTOBER/NOVEMBER 2023

INDONESIA: POST MARKET TESTING OF MEDICAL DEVICES – OCTOBER/NOVEMBER 2023

  • 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.

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INDONESIA: Expansion of E-purchasing Access for Private Health Facilities Participating in the JKN (National Health Insurance Scheme) – February/March 2023

INDONESIA: Expansion of E-purchasing Access for Private Health Facilities Participating in the JKN (National Health Insurance Scheme) – February/March 2023

  • 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.

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INDONESIA: Substitution of Import Medical Devices with Domestic Medical Devices in Electronic Catalog / e-Katalog of Health Sectoral – September/October 2022

INDONESIA: Substitution of Import Medical Devices with Domestic Medical Devices in Electronic Catalog / e-Katalog of Health Sectoral – September/October 2022

  • 2022-09-27 07:58:07

Effective since 6th July 2022, Indonesia’s Ministry of Health has issued Ministry of Health Decree number HK.01.07/MENKES/1258/2022 concerning Substitution of Imported Medical Devices with Domestic Medical Devices in the Electronic Catalog / e-Katalog of the Health Sector that implement the freeze/ unfreeze mechanisms.

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