Writer | Dra. Rully Makarawo, Apt., et al. | |
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Publisher | Ministry of Health RI | |
Year | 2021 | |
ISBN | 978-623-301-271-3 | |
Dimension | ||
Number of Pages | 300 | |
Description | In accordance with regulatory harmonization in the ASEAN region in the ASEAN Medical Devices Directive (AMDD), the classification of medical devices and in vitro diagnostic medical devices is divided into 4 (four) risk classes ranging from low risk (class A) to high risk (class D). Indonesia, which has ratified the AMDD in 2018, has adjusted the regulation by compiling the classification, type and naming of medical devices as stipulated in the Decree of the Minister of Health of the Republic of Indonesia Number HK.01.07 / Menkes / 4745 / 2021 concerning Types and Naming of Medical Devices. To be able to make it easier to understand the types and naming of medical devices, further explanation and description of the types of medical devices and in vitro diagnostic medical devices are needed by preparing the Codification and Nomenclature of Medical Devices and In Vitro Diagnostic Medical Devices. |