In-vitro diagnostic Medical Devices (IVMDs) - Rapid Diagnostic Tests (RDTs) Archives

In-vitro diagnostic Medical Devices (IVMDs) - Rapid Diagnostic Tests (RDTs)

Guidance Document on Validation of Rapid Diagnostics for Pathogen Identification and Antimicrobial Susceptibility Testing (AST) – 2025

Posted by: Hitesh Gupta February 4, 2025

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Regulation/Guidelines

Organic Food Labelling In India| Certification, and Import of Organic Food in India

This Article is All About Organic Food Labelling In India and Certification, and Import of Organic Food in India. Explained in Detail About What is Organic Food labelling? Summary Organic...

21st April, 2025

Regulation/Guidelines

Cosmetic Label Compliance India : A Guide to Compliance

Introduction Looking for Cosmetic Label Compliance India? Are you a cosmetic manufacturer or importer navigating the complex world of Indian regulations? Ensuring your product labels comply with the latest cosmetic...

26th March, 2025

Regulation/Guidelines

Clinical Investigation Approvals: An Overview of Forms MD-22 and MD-23

Summary As per MDR 2017, “clinical investigation” means the systematic study of an investigational medical device in or on human participants to assess its safety, performance or effectiveness. Clinical investigations...

15th January, 2025

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...