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 MoreVietnam Medical Device Registration to Address the Medical Supply
This Article deals with the new Decree Released by the Vietnam Medical Device Registration on March 4, 2023. The Deputy Prime Minister Tran Hong Ha signed Decree No. 07/2023/ND-CP. This amendment’s goal is to correct flaws, restrictions, and limitations that […]
Read MoreMedical Device Registration Authority Subscription, Malaysia
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 […]
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Import 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 MoreIncreasing Importation of Medical Devices affecting SME’s
This news article deals with the increasing demand for Imported Medical Devices and Products into India. In India, the Medical Device Industry Importation has surged by 41% this year leading to the shut down of several local indian companies. The […]
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Voluntary 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 […]
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Unique 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 […]
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Non-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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Dermatology and Plastic Surgery as Medical Device India- Non Notified Medical Device Registration
This article deals with the latest rules of Dermatology and Plastic Surgery 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 […]
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Rheumatology 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 […]
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