Amendment in the Drug Rules, CDSCO, MDR India
This article is about MDR India for a notice published in the Indian Gazette on June 14, 2022, by the Indian Government’s Ministry of Health and Family Welfare. The CDSCO is requesting feedback and suggestions from individuals who are likely […]
Read MoreFAQ about Medical Device Registration in India
Introduction The process of medical device registration in India is regulated by the Central Drugs Standard Control Organization (CDSCO), which operates under the Ministry of Health and Family Welfare. All the medical devices must be registered with the CDSCO before […]
Read MoreExemption of Class A Non-Sterile/Non-Measuring Medical Devices from Licensing Regime
Introduction This Article deals with Class A Non-Sterile/Measuring Medical Devices which are now exempted from the MD-15 Requirement. The Ministry of Health and Family Welfare has released a new amendment to the Medical Devices Regulations (MDR) 2017. This includes provisions […]
Read MoreVoluntary Registration of Medical Devices in India
Introduction – Voluntary Registration of Medical Devices in India The Central Drugs Standard Control Organization (CDSCO) regulates Medical Devices in India. Until now, only the Notified Medical Devices have been regulated (there are 37 in this list) , mainly focusing […]
Read MoreOperation Theatre as Medical Device India-Non Notified Medical Device Registration
Introduction – Operation Theatre as Medical Device India This article deals with the latest rules of Operation Theatre Products as a Medical Device India – Non Notified Medical Device Registration. Indian healthcare regulators at the Central Drugs Standard Control Organization […]
Read MoreUnique Device Identification Number
What is a Unique Device Identification Number ? This blog deals with the Unique Identification Number and its guidelines. Singapore’s medical Device Market Regulator, the Health Science Authority (HSA), has published the final guidance for Unique Device identification (UDI) regulations […]
Read MoreNon-Notified Registration India – Amendment
Introduction: Non-Notified Registration India – Amendment This article deals with Medical Device Amendment for Non-Notified Registration India. The Central Drugs Standard Control Organisation (CDSCO) is the Indian Advisory Body for Pharmaceuticals and Medical Devices wherein all Notified are regulated by […]
Read MoreRheumatology as Medical Device India-Non Notified Medical Device Registration
Introduction – Rheumatology as Medical Device India This article deals with the latest rules of Rheumatology Products as a Medical Device India – Non Notified Medical Device Registration. Indian healthcare regulators at the Central Drugs Standard Control Organization (CDSCO) have […]
Read MoreMedical Device Amendment for Non-Notified Devices – Interventional Radiology Products
Previously only Implantable Medical Devices had to be registered with the CDSCO. However, now All Interventional Radiology Products such as Cameras, Bone Densitometers, Scanners, Nuclear Probes, Ultrasonic Monitors, X-Ray Systems, Radiographic Systems, Imaging Systems, Holders, Image Analyzers and Other Interventional […]
Read MoreSoftware as Medical Device India – Non Notified Medical Device Registration
This article deals with the latest rules of Software as Medical Device India –Non Notified Medical Device Registration. Previously only Implantable Medical Devices had to be registered with the CDSCO. However, now All Software Products such as X-Ray Systems, Monitors, […]
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