Medical Device Regulatory Indonesia

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Indonesia - Healthcare (Medical Devices & Equipment)

https://www.trade.gov/country-commercial-guides/indonesia-healthcare-medical-devices-equipment

Based on Ministry of Trade regulations, companies in Indonesia are expected to engage with one or more local distributors to distribute their medical device products to hospitals and clinics. To avoid duplication of efforts, some medical device importers outsource part or all of their warehousing functions to … See more

Medical Device Registration in Indonesia

https://asiaactual.com/indonesia/medical-device-registration/

The primary government agency responsible for regulation of medical devices in Indonesia is the Ministry of Health …

Indonesia Medical Device Registration | Andaman Medical

https://andamanmed.com/regulatory-services/medical-device-registration/indonesia/

As a signatory to the AMDD (ASEAN Medical Device Directive), Indonesia has integrated the ASEAN Common Submission Dossier Template (CSDT) into its online registration …

Indonesia Medical Device Subsidiaries - International …

https://www.trade.gov/market-intelligence/indonesia-medical-device-subsidiaries

Indonesia Removes 49 percent Foreign Equity Cap on Medical Device Importers. Presidential Regulation No. 10 of 2021 on “Investment Business Fields” …

Indonesia Medical Device Regulatory Updates 2020-2021

https://arazygroup.com/indonesia-medical-device-regulatory-updates-2020-2021/

This tool was established based on ASEAN Medical Device Directive (1). 2. Simplified registration pathway for certain low-risk medical devices (notification) …

Medical device Registration Process In …

https://credevo.com/articles/2021/06/05/medical-device-registration-process-in-indonesia/

Regulatory authority The National Agency of Drug and Food Control (NADFC) under the Indonesian Ministry of Health (MoH) regulates medical devices. The …

Indonesia Medical Device Regulations | RegDesk

https://www.regdesk.co/resource-library/indonesia/

Medical devices are instruments, apparatuses, machines and/or implants that do not contain medicines used to prevent, diagnose, cure and relieve diseases, treat sick …

Medical Devices Registration in Indonesia

https://emerhub.com/indonesia/medical-devices-registration-indonesia/

Selling and Importing Medical Devices in Indonesia. Indonesia strongly depends on imported medical devices to support its healthcare sector. The medical …

Medical Devices Regulatory Services in Indonesia

https://www.freyrsolutions.com/medical-devices-regulatory-services-in-indonesia

Medical Devices in Indonesia are regulated by National Agency of Drug and Food Control (NADFC) functioning under Indonesian Ministry of Health (MOH). The latest regulation in …

Medical Devices Regulatory Services - Freyr Solutions

https://medicaldevices.freyrsolutions.com/medical-devices-regulatory-services-indonesia

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