Mandatory 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 them. The responsibility lies with the Drugs Controller General of India (DCGI) under the CDSCO […]
India Risk Classification for Dermatology and Plastic Surgery as a Medical Device
Introduction – Dermatology and Plastic Surgery Equipment Classification in India This article discusses the latest rules for Dermatology and Plastic Surgery equipment classification in India as per the Medical Device Rules 2017 in India. Indian healthcare regulators at the Central Drugs Standard Control Organization (CDSCO) have issued significant risk-based classification lists for all Dermatology and […]
India Risk Classification for Rheumatology as a Medical Device
Introduction – Rheumatology Equipment Classification in India This article discusses the latest rules for Rheumatology equipment classification in India as a Medical Device under the Medical Device Rules 2017 in India. Indian healthcare regulators at the Central Drugs Standard Control Organization (CDSCO) have issued a substantial risk-based classification for all Rheumatology Products. All Rheumatology Products […]
India Risk Classification for Interventional Radiology Products
Introduction – Interventional Radiology Equipment Classification in India The classification of Interventional Radiology Products plays a vital role in ensuring their safety, efficacy, and regulatory compliance. These devices, which include cameras, scanners, nuclear probes, ultrasonic monitors, X-ray systems, and more, are important for accurate diagnostics and therapeutic procedures. The CDSCO classifies these devices under the […]
India Risk Classification for Software as Medical Device
Introduction – Software as Medical Device (SaMD) Classification in India The rapid growth of digital health technologies has significantly transformed the healthcare industry in India. Innovations such as smartwatches, health tracking devices, wearables, telemedicine solutions, and devices incorporating Artificial Intelligence (AI) and Machine Learning (ML) algorithms have become integral to healthcare. The Central Drugs Standard […]
India Risk Classification for Nephrology and Renal Care as a Medical Device
Introduction – Nephrology and Renal Care Equipment Classification in India as per the Updated CDSCO Medical Device Rules This article discusses the regulatory framework for Nephrology and Renal Care equipment classification in India, emphasizing the importance of compliance with the Medical Device Rules 2017 in India. The Central Drugs Standard Control Organization (CDSCO), through notification […]
India Risk Classification for Radiotherapy as a Medical Device
Introduction – Radiotherapy Equipment Classification in India as per the Updated CDSCO Medical Device Rules Radiotherapy devices play an important role in cancer treatment and other medical applications requiring precise radiation delivery. The Central Drugs Standard Control Organization (CDSCO) classifies these devices under the Medical Device Rules 2017 in India based on their intended use, […]
India Risk Classification for Oncology as Medical Device
Introduction – Oncology as Medical Device India This article deals with the latest rules of Oncology Products as a Medical Device as per Medical Device Rules 2017 in India. Indian healthcare regulators at the Central Drugs Standard Control Organization (CDSCO) have issued substantial risk based classification lists for Oncology Equipment classification in India, highlighting its […]
India Risk Classification for Pediatrics and Neonatology as a Medical Device
Introduction – Pediatrics and Neonatology as a Medical Device in India This article focuses on the classification of Pediatrics and Neonatology devices. The Central Drugs Standard Control Organization (CDSCO) has established risk-based classification lists to ensure these devices meet international safety and efficacy standards. This classification helps manufacturers understand the risk level and intended use […]
India Risk Classification for Personal Protective Equipment
Introduction: Personal Protective Equipment Classification in India Personal Protective Equipment (PPE) plays a critical role in safeguarding healthcare professionals, patients, and the general public from various health hazards. Under the Medical Device Rules 2017 in India, PPE is classified based on risk levels to ensure compliance with safety and regulatory standards. As part of its […]