Regulatory agencies are starting to catch up on their guidance agendas, including the European Union’s Medical Device Coordination Group (MDCG), which has posted a guidance for risk classification.
The Global Harmonization Task Force issued a guidance that provides 17 rules for device classification, according to a MassDevice report. The guidance provides rules for classification of devices and ...
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The Central Drugs Standard Control Organisation (CDSCO) has released a draft guidance document on Medical Devices Software, under the Medical Devices Rules (MDR), 2017, to bring in specific regulatory ...
The Central Drugs Standard Control Organisation (CDSCO) has announced risk classification of 119 medical devices pertaining to radiotherapy under the Medical Devices Rules (MDR), 2017, as part of ...