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INDONESIA: Vaccine and Pharmaceutical (medical) Storage / Refrigerator No Longer Considered as Medical Devices

INDONESIA: Vaccine and Pharmaceutical (medical) Storage / Refrigerator No Longer Considered as Medical Devices

  • 2021-02-22 01:36:27

The Indonesian Ministry of Health has stated that Vaccine and Pharmaceutical (medical) Storage / Refrigerator products are no longer considered medical devices locally. This is stipulated on an announcement on January 19, 2021. Therefore, Vaccine and Pharmaceutical (medical) Storage / Refrigerator can be freely sold in Indonesia without getting Medical Device Marketing Authorization Certificate from MoH.

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INDONESIA: "Double Agent" Scenario in Indonesia

INDONESIA: "Double Agent" Scenario in Indonesia

  • 2021-01-19 03:20:16

Indonesia's Ministry of Health has explained about the scenario of "Double Agent" at a seminar that was held recently. "Double Agent" is the term used to refer multiple authorizations for the one product brand originated from the same Principal or Manufacturer to the several Medical Device Distributors.

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INDONESIA: The National Public Procurement Agency Open E-katalog Registration for Domestic and COVID-19 related Medical Devices – Oct, 2020

INDONESIA: The National Public Procurement Agency Open E-katalog Registration for Domestic and COVID-19 related Medical Devices – Oct, 2020

  • 2020-11-26 03:47:29

In 2020, National Public Procurement Agency (in Indonesia known as LKPP) has opened E-katalog registration for domestic medical device products and several medical products for handling Covid-19. Due to the Covid-19 pandemic, there are several stages in the E-katalog registration process which is carried out online, namely verification / clarification process. However, the price negotiation stage is still carried out face to face. There is also a possibility that e-katalog registration for imported medical products will be opened around this year.

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INDONESIA: Provision of customs and / or excise facilities as well as taxation of imported goods for the purpose of handling COVID-19 – June, 2020

INDONESIA: Provision of customs and / or excise facilities as well as taxation of imported goods for the purpose of handling COVID-19 – June, 2020

  • 2020-06-16 05:58:49

Ministry of Finance Decree ( PMK-34/PMK.04/2020) stated that import of goods for the purposes of handling the COVID-19-related medical products are granted with customs and / or excise and taxation facilities. Applicant could apply the exemption through INSW website (http://www.insw.go.id/). This policy is started from 17 April 2020 until further date set by The National Disaster Mitigation Agency (BNPB).

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INDONESIA: Announcement of withdrawal and removal of medical devices contain mercury - March, 2020

INDONESIA: Announcement of withdrawal and removal of medical devices contain mercury - March, 2020

  • 2020-03-16 06:38:53

Ministry of Health has issued a Circular letter number HK.02.02 / VI / 1465/2019 about withdrawal and elimination of medical devices that contain mercury from the market. This circular letter is addressed to Head of medical devices manufacturer and Head of medical device distributor in throughout Indonesia. They need to take several actions to help the withdrawal and elimination process of medical devices that contain mercury.

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