Medical Device license holders mandated to report all suspected unexpected serious adverse events to the Materiovigilance Programme of India (MvPI) for timely risk identification and regulatory compliance

Medical Device license holders mandated to report all suspected unexpected serious adverse events to the Materiovigilance Programme of India (MvPI) for timely risk identification and regulatory compliance

Medical Device license holders mandated to report all suspected unexpected serious adverse events to the Materiovigilance Programme of India (MvPI) for timely risk identification and regulatory compliance

by Lexplosion | Jun 3, 2024 | Central, OPS

CDSCO has issued a Circular re-iterating the mandate of reporting any suspected unexpected serious... Read More

Ministry of Consumer Affairs issues Direction for implementation of exemptions under the Legal Metrology (Packaged Commodities) Rules, 2011 on Medical Device

Ministry of Consumer Affairs issues Direction for implementation of exemptions under the Legal Metrology (Packaged Commodities) Rules, 2011 on Medical Device

by Lexplosion | Aug 1, 2023 | Central, Medical devices, OPS

The Ministry of Consumer Affairs (“Ministry”) has issued an order reiterating the following... Read More

Medical Devices Rules amended to provide for setting up of State Medical Devices Testing Laboratories

Medical Devices Rules amended to provide for setting up of State Medical Devices Testing Laboratories

by Lexplosion | Jun 15, 2023 | Central, Medical devices, OPS

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Andhra Pradesh Health Department advises manufacturers, dealers, wholesalers etc. against sale of Ultrasound Machines without ensuring valid registration certificate and NOC under PC & PNDT Act

Andhra Pradesh Health Department advises manufacturers, dealers, wholesalers etc. against sale of Ultrasound Machines without ensuring valid registration certificate and NOC under PC & PNDT Act

by Anum Ahmed | May 31, 2023 | Andhra Pradesh, Medical devices, OPS

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NPPA extends timeline for trade margin cap imposed on medical devices like pulse oximeter, nebulizer, glucometer etc. till 30th June, 2023

NPPA extends timeline for trade margin cap imposed on medical devices like pulse oximeter, nebulizer, glucometer etc. till 30th June, 2023

by Lexplosion | Apr 3, 2023 | Central, OPS

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