Eight notified bodies have now been registered with the CDSCO intends to carry out audit of a manufacturing site of Class A or Class B of medical devices.
More CDSCO has issued a notice recently regarding intended uses of implantable medical devices, as stipulated in the Fifth Schedule (Clause 3.5) of Medical Devices Rules, 2017.
More The Indian Central Drugs Standard Control Organization (CDSCO) has set risk classifications for 12 products scheduled for notification and regulation as medical devices starting April 1, 2020.
More Pharmaceutical drugs in India will from now on abide by the newly notified “New Drugs and Clinical Trials Rules, 2019”. These Rules have been issued in hopes that the rules will increase and improve clinical research in India, which hosts only 1.2% of the world’s clinical trials despite having a high burden of disease.
More Pharmaceutical drugs in India will now on abide by the newly notified “New Drugs and Clinical Trials Rules, 2019”. These Rules have been issued in hopes that the rules will increase and improve clinical research in India, which hosts only 1.2% of the world’s clinical trials despite having a high burden of disease.
More The Indian government has issued draft Quality Control Orders (QCOs) for medical electrical equipment, sphygmomanometers, clinical electrical thermometers, blood glucose monitoring system, gloves and surgical blades, to better ensure their safety and effectiveness.
More 8 medical devices have been newly notified as “drugs” by government of India. These devices will henceforth be closely regulated and monitored for safety and performance.
More Nearly eight months after the implementation of the Medical Device Rules 2017, the Indian Pharmacopoeia Commission (IPC) has brought out the first reference document for medical devices manufactured and sold in the country.
More According to rule 19 of the Medical Device Rules 2017, the central government may establish “Central Medical Devices Testing Laboratories” for the purpose of
More The regulatory standards for the approval of IVD devices keep on changing time to time because of the continuous improvements and modifications made related to their better performance level. There was a revision for “glucometer test strips” in 2013 as mentioned in IS/ISO 15197: 2013.
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