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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 […]

Medical Device Registration Authority Subscription, Malaysia

|Posted In: Dental , Import License , Medical , Medical Device , medical device , Medical Device Registration , News , South East Asia Medical Device Registration

This Article deals with the Medical Device Registration in Malaysia. The Medical Device Registration Authority of Malaysia (MDA), also known as Medical Device Authority-Regulatory Information Subscription, released a notice on how to stay up to date with the MDA for […]

Exemption of Class A Non-Sterile/Non-Measuring Medical Devices from Licensing Regime

|Posted In: Blog , Blog Morulaa , CDSCO , Dental , Medical , Medical Device , medical device , Medical Device Registration , Medical Device Registration in India , Medical Device Registration in india

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 […]

Import of Medical Devices into India

|Posted In: Blog , Blog Morulaa , CDSCO , Dental , Import License , Medical , medical device , Medical Device

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 […]

Software as Medical Device Update by TGA

|Posted In: Dental , Medical , Medical Device , medical device , Medical Device Registration , News , Software as Medical Device

The following article deals with the latest update for Software as Medical Device by The Australian TGA (Therapeutic Goods Administration). Software based Medical Devices (SaMD’s) are regulated by the TGA and must be included in the Australian Register of Therapeutic […]

Dental as Medical Device in India – Non Notified Medical Device Registration

|Posted In: CDSCO , Dental , Import License , Indian Medical Device Market , Medical , Medical Device Registration , Medical Device Registration in India , Medical Device Registration in india , Non-Notified Medical Device Registration | 0

This article deals with the latest rules of Dental as a Medical Device in India – Non Notified Medical Device Registration (List updated on 3rd June, 2022). Indian healthcare regulators at the Central Drugs Standard Control Organization (CDSCO) have issued […]

Cardiovascular as Medical Device in India – Non Notified Medical Device Registration

|Posted In: Blog , Blog Morulaa , CDSCO , Dental , Medical , medical device , Medical Device , Medical Device Registration , Medical Device Registration in India , Medical Device Registration in india , Non-Notified Medical Device Registration | 0

Introduction This article deals with the latest rules of Cardiovascular as a Medical Device in India – Non Notified Medical Device Registration. Indian healthcare regulators at the Central Drugs Standard Control Organization (CDSCO) have issued substantial new risk-based classification lists […]

Pain Management as Medical Device India – Non Notified Medical Device Registration

|Posted In: Blog , Blog Morulaa , Dental , Medical , medical device , Medical Device , Medical Device Registration , Medical Device Registration in india , Non-Notified Medical Device Registration | 0

Introduction – Pain Management as Medical Device India This article deals with the latest rules of Pain Management as a Medical Device India – Non Notified Medical Device Registration. Indian healthcare regulators at the Central Drugs Standard Control Organization (CDSCO) […]

Anesthesiology as Medical Device in India – Non Notified Medical Device Registration

|Posted In: Blog , Blog Morulaa , Dental , Indian Medical Device Market , Medical , medical device , Medical Device , Medical Device Registration , Medical Device Registration in India , Medical Device Registration in india , Non-Notified Medical Device Registration | 0

Anesthesiology as Medical Device in India – Non Notified Medical Device Registration This article deals with the latest rules of Anesthesiology as a Medical Device in India – Non Notified Medical Device Registration. Indian healthcare regulators at the Central Drugs […]

Medical Devices Amendments Given By CDSCO

This article deals with various amendments which happened in the fields of Anesthesiology, Cardiovascular, Physical Support, Radiology, Dermatological & Plastic Surgery and Rehabilitation. With several changes being constantly introduced by the CDSCO, this current change is mainly dealing with the […]

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