Software as Medical Device, India – Registration Requirements
Digital Health is fast emerging and is growing rapidly. New technologies such as telemedicines, Artificial Intelligence (AI) and Machine Learning (ML), Wearables for Glucose Monitoring, ECG etc are constantly evolving. Healthcare regulators across the world are devising regulations to help […]
Read MoreAmendment 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 MoreImport of Medical Devices into India
Introduction – Import of Medical Devices into India This article deals with the import of Medical Devices into India. The importation of Medical Devices in India is of prime importance for every manufacturer. In order to import into India, manufacturers have […]
Read MoreNew Draft Regulations for IVD’s in India
This news article deals with the updates in the IVD regulations in India. They have come up with three drafts as follows – Draft Guidance on Post-Market Surveillance of In-vitro Diagnostic Medical Device (IVDMD) – The CDSCO has issued an […]
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 […]
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