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INDONESIA: Registration of prospective providers in Electronic Catalog (E-Cat) for medical device and household-health product through the negotiation method – December, 2019

INDONESIA: Registration of prospective providers in Electronic Catalog (E-Cat) for medical device and household-health product through the negotiation method – December, 2019

  • 2020-02-21 06:56:04

In Indonesia, E-Katalog become the most popular platform for the public hospital or government related institution to find required medical device equipment. In October, Government invite Medical Device Company to submit an offering of Medical Devices and Household Health Supplies products to be included in E-Katalog.

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INDONESIA: Medical device amendment criteria in Indonesia - December, 2019

INDONESIA: Medical device amendment criteria in Indonesia - December, 2019

  • 2020-02-21 06:54:34

Changing some information after device approved can be done through amendment which has shorter timeline for approval. However, not all of the changes in the device can apply for amendment. Indonesia Ministry of Health elaborate specific criteria for the type of changes that can be reported as amendment to MoH.

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INDONESIA: Digital signature implementation - December, 2018

INDONESIA: Digital signature implementation - December, 2018

  • 2020-02-12 14:03:26

Starting January 2019, Medical Device Marketing Authorization License will be issued in electronic form. This is in accordance to PMK No. 62 year of 2017 Article 22, which stated that Marketing Authorization License will not require stamp and wet signature anymore.

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