Medical Device Registration in India Archives -

Drugs & Cosmetics Act and PWM: Effects on Medical Devices

The Drugs & Cosmetics Act of 1940, underpinning the regulatory framework for healthcare in India, has paved the way for remarkable advancements in medical diagnostics and treatment through the innovation and implementation of medical devices. India’s healthcare sector, expected to […]

FAQs by CDSCO: Key Highlights and Updates

|Posted In: Blog , CDSCO , Medical Device , Medical Device Registration in India

This article talks about the recently published FAQs by CDSCO and is structured under clear headings for better readability and understanding. In the dynamic landscape of medical device registration in India, the Central Drugs Standard Control Organization (CDSCO) plays a […]

National Single Window System (NSWS), India

|Posted In: Blog , CDSCO , Medical Device , Medical Device Registration in India

National Single Window System (NSWS) – The Central Drugs Standard Control Organization (CDSCO) of India on January 01, 2024, published a notice talking about the release of a new portal called National Single Window System (NSWS). The National Single Window […]

Software as Medical Device, India – Registration Requirements

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

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 […]

Amendment in the Drug Rules, CDSCO, MDR India

|Posted In: CDSCO , Medical , medical device , Medical Device , Medical Device Registration , Medical Device Registration in india , Medical Device Registration in India , News

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 […]

FAQ about Medical Device Registration in India

|Posted In: Blog , Blog Morulaa , CDSCO , 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

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 […]

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 […]

Voluntary Registration of Medical Devices in India

|Posted In: Blog , Blog Morulaa , CDSCO , Import License , 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 – 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 […]

Operation Theatre as Medical Device India-Non Notified Medical Device Registration

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

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 […]

Unique Device Identification Number

|Posted In: Blog , CDSCO , Import License , Indian Medical Device Market , Medical Device , Medical Device Registration , Medical Device Registration in India , Medical Device Registration in india , Uncategorized | 0

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 […]

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