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API Registrations of Drugs In India

Posted by: Jitendar Chauhan April 28, 2023

Active pharmaceutical ingredient (API) is defined

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28th April, 2023

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Regulation/Guidelines

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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

CT-16

CT-16

API Registrations of Drugs In India

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