Clinical Investigation Approvals: An Overview of Forms MD-22 and MD-23
Summary Short Description Strict regulatory protocols govern clinical investigations for medical devices. Central to this process are forms MD-22 and MD-23. Form MD-22 is an application to Central Licencing Authority (CLA) for conducting investigation on an investigational medical device whereas MD-23 is the approval of same. These ensure safety, performance […]
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Clinical validation is an integral part of clinical evaluation of an SaMD, which is defined as a set of ongoing activities conducted for the assessment and analysis of an SaMD’s clinical safety, effectiveness and performance as intended by the manufacturer.
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Explore the various types of FSSAI licenses available in Delhi. Learn which license is right for your food business and how to apply. Get a clear understanding of the different FSSAI licenses in Delhi and step-by-step guidance on the application process.
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Regulatory Challenges of SaMD: Navigating Global Standards and Compliance
Navigating Software as a Medical Device regulation involves addressing varying global standards, including risk-based classifications.
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Revised Schedule M – Revolutionising pharmaceutical marketing
- Schedule M is a part of the Drugs and Cosmetics Act, 1945.
- It outlines the good manufacturing practices and requirements of premises, plant, and equipment for pharmaceutical products.
- Revised changes in Schedule M include the incorporation of a pharmaceutical quality system, quality risk management, product quality review, qualification and validation of equipments, change control management, Self-inspection, constituting quality audit team.
- Implementation of a computerized storage system and validation of GMP-related computerised system.
Safety and Efficacy Assessment in Non-Specified Food Approval: Focus on Functional Foods
The Food Safety and Standards (Approval for Non-Specified Food and Food Ingredients) Regulations, 2017, initially established by the FSSAI, served as a framework for regulating non-specified food products and ingredients.
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The Future of SaMD: Emerging Trends and Innovations
The future of Software as a Medical Device will see breakthroughs in Artificial Intelligence-based diagnostics, personalised treatments, and remote monitoring.
Regulation/Guidelines
Understanding SaMD: What Makes Software a Medical Device?
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.
Regulation/Guidelines
Quality Management Systems for SaMD: Best Practices and Standards
Software as a Medical Device faces many challenges related to quality management systems.