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MALAYSIA: MDA Announced the New Guidance on Harmonized Risk Classification of Medical Devices – October/November 2022

MALAYSIA: MDA Announced the New Guidance on Harmonized Risk Classification of Medical Devices – October/November 2022

  • 2022-10-25 06:38:16

The MDA published the First Edition of the Guidance Document of the "Harmonized Classification of Medical Devices in ASEAN" (MDA/GD/0062) on September 5, 2022. This guidance document provides the harmonized list of risk classification of medical devices including in-vitro diagnostic (IVD) medical devices, based on their intended use or purpose as claimed by the manufacturer.

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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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