On September 3, 2020, the Indian Central Drugs Standard Control Organization (CDSCO) published the “Notice regarding classification of non notified …
Continue reading “INDIA: new categories for the classification of non notified devices”
To reinforce the regulations on medical devices in India, the Central Drugs Standard Control Organization (CDSCO) published two amendments to …
Continue reading “INDIA: CDSCO publishes two amendments of 2017 Medical Device Rule”
Guidance for medical devices (MDs) To support all the stakeholders in the implementation of the Regulation on Medical Devices 2017 …
Continue reading “INDIA: Operational guidance for medical devices and IVDs”
On March 15, the Department of Pharmaceuticals (DoP) published the draft Guidance for Public Procurement of Medical Devices, which proposes …
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The new Indian Regulation on medical devices and IVDs brought significant restrictions to IVD devices. The number of IVDs requiring …
In view of the new Medical Device Rules 2017 entry into force, two measures were recently approved in India relating …
Continue reading “INDIA: measures in preparation for the Medical Device Rules 2017 were approved”
The information on this page is valid and current as of April 2018. The legislative and regulatory provisions are subject …