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New Rules for Clinical Trials and Drugs Promote Research and Ensure Patient Safety

Posted by: Saurangi Shah May 30, 2019

Ministry of Health and Family Welfare of India not

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30th May, 2019

Draft of New Regulations for Clinical Trials in India Favours Drug Development in the Country

Posted by: Saurangi Shah May 9, 2019

The Ministry of Health and Family Welfar

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9th May, 2019

Medical Devices Rules 2017: An Overview

Posted by: Saurangi Shah January 9, 2017

What is a medical device? A medical device is any

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9th January, 2017

What's New 2?

Regulation/Guidelines

Regulatory Challenges of SaMD: Navigating Global Standards and Compliance

Overview Navigating Software as a Medical Device regulation involves addressing varying global standards, including risk-based classifications. Challenges include managing risks, demonstrating clinical evidence, and ensuring data security. Harmonisation efforts and...

4th November, 2024

Regulation/Guidelines

The Future of SaMD: Emerging Trends and Innovations

Overview The future of (SaMD) Software as a Medical Device will see breakthroughs in Artificial Intelligence-based diagnostics, personalised treatments, and remote monitoring. Emerging trends emphasise real-time data integration, stronger regulatory...

4th November, 2024

Regulation/Guidelines

Understanding SaMD: What Makes Software a Medical Device?

Overview Software as a Medical Device refers to software applications designed for medical purposes, such as diagnosis, treatment, or monitoring, without being part of a physical device. Software as a...

4th November, 2024

Regulation/Guidelines

Quality Management Systems for SaMD: Best Practices and Standards

Overview Quality Management Systems for SaMD requires compliance with regulatory standards, implementation of robust quality management systems, and risk management through design controls, testing, and post-market surveillance. It also involves...

22nd October, 2024

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New Rules for Clinical Trials and Drugs Promote Research and Ensure Patient Safety

Draft of New Regulations for Clinical Trials in India Favours Drug Development in the Country

Medical Devices Rules 2017: An Overview

For Importers To India

Drug

Biologicals

Food Supplements

Medical Device

IVD

Food

Cosmetic

Other

For Manufacturer To India

Drug

Biologicals

Food Supplements

Food

Medical Device

IVD

Cosmetic

Other