Medical Device & IVD Regulatory | SCIENCE ARENA

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Quality Management System

Standards and Certification: Identifying Certifiable & Non-Certifiable Standards

bySCIENCE ARENA -March 06, 2025

In today's globalized and highly competitive world, standards play a crucial role in ensurin…

In Vitro diagnostic (IVD)

The Regulatory Landscape and Future Outlook of Microfluidic-Based Diagnostic Devices

bySCIENCE ARENA -March 05, 2025

Microfluidic diagnostic devices, also known as micro flow diagnostic devices, have emerged as a …

Guidance on Loan License under D&C Act and Medical Device Rules

bySCIENCE ARENA -February 18, 2025

A Loan License is a regulatory provision under the Drugs and Cosmetics Act, 1940 (D&C Act) a…

The Call of India for Refurbished Medical Devices - CDSCO's Clarification

bySCIENCE ARENA -January 16, 2025

Refurbished medical devices are gaining traction in India as a cost-effective and sustainable al…

Impact of Change in Constitution of Firm on Your Licenses

bySCIENCE ARENA -January 15, 2025

Are you worried about the impact of a change in the constitution of your firm on your regulatory…

Types of Licenses Granted by CDSCO in Respect of the Kind of Business in India under Medical Device Rules 2017

bySCIENCE ARENA -January 12, 2025

The Central Drugs Standard Control Organization (CDSCO) serves as the National Regulatory Author…

FDA Evaluates Contaminants, Including Metals, in Tampons Through Independent Literature Review

bySCIENCE ARENA -December 24, 2024

The U.S. Food and Drug Administration (FDA) has released findings from an independent review of …

Quality Management System

Understanding and Determining the Scope in a Quality Management System

bySCIENCE ARENA -December 11, 2024

This article explores the various definitions and contexts of "scope" in a Quality Ma…

FDA Medical Device Classification: A Guide to US FDA 😷Administration

bySCIENCE ARENA -December 08, 2024

Medical devices are integral to modern healthcare, ranging from simple tools like bandages to ad…