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New Regulations of Government of India Considers 8 Medical Devices as Drugs

Medical devices market in India is booming now. There are lots of medical device innovation and import happening from all over the world. In order to maintain quality assurance and safety, Ministry of Health and Family Welfare bring new regulations for eight important and commonly used categories of medical devices. […]

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Regulation/Guidelines

Principles for Safety & Performance of Medical Devices

The new ‘Medical Devices Rules, 2017’ have already been published and will commence w.e.f January 1st, 2018. A guidance document has been issued by the Ministry of Health & Family Welfare (MoH&FW) for the said rules under the ‘Rule 6’ after consulting medical devices & in-vitro diagnostic devices (IVD) industry […]

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News

New Medical Device Rules To Be Rolled Out In 2018

The Drugs and Cosmetics Act, 1940, has been governing drugs and medical devices since 1940 and has received multiple iterations each year. Owing to the significant changes that have occurred in the healthcare and pharmaceutical industry and constant requests from leaders in these industries, an overhaul was long overdue. In […]

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NEW NOTICE BY DCGI FOR MEDICAL DEVICES

The Government of India is revamping the existing regulations on medical devices to be at par with the global norms and standards, to have a better control over their manufacture, import and sale. A new notification was released by the Drugs Controller General of India (DCGI) in Nov 2018 regarding […]

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Insight

Medical Devices Rules, 2017: An Overview

CDSCO issued a draft of Medical Devices Rules, 2016 through a gazette notification (No. 724) published on October 17, 2016

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Insight

MEDICAL DEVICE REGISTRATION IN INDIA

Medical device industry is still nascent in India, most devices are manufactured globally and imported

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Insight

CASE STUDY: Facilitator at a Indo-German Medical Device Conclave

The Indian healthcare industry is one of the world’s largest healthcare setup. Being the 2nd largest population in the world, the healthcare of this burgeoning people is funded by either healthcare insurance, government, employer but largely by the patient themselves. With increasing interest by the Indian Government to organize and […]

Regulation/Guidelines

New Regulations for Medical Devices Industry by CDSCO

Nowadays, therapeutic treatment based on medical devices is providing technologically advanced solutions for the management, diagnosis, treatment,mitigation or prevention of several diseases. Thus, the demand continues to grow in the market at a tremendous rate leading to a renewed interest in the scientific development and research in the field of […]

News

Self-Assessment/Audit of Unit for GMP/GLP Compliance

The Indian government has brought about some major changes with regards to the rules and regulations governing the manufacturing to enhance the quality of products used in the healthcare industry. As India being a major market for the healthcare-related products and its services, these modifications to the existing regulations are […]

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