BLOGS

Materiovigilance Programme of India (MvPI) :DCGI Calls for Strengthening Medical Device Adverse Event Reporting

The Drugs Controller General of India (DCGI) has called for the timely reporting of adverse events related to medical devices…

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Materiovigilance Programme of India (MvPI) :DCGI Calls for Strengthening Medical Device Adverse Event Reporting
Intraocular Lenses and Regulatory Processes

Intraocular Lenses and Regulatory Processes

Intraocular Lenses (IOLs) are special lenses put inside the eye during surgery to replace the natural lens. This often happens…

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CDSCO Update: New Online PSUR Guidelines in India

The Central Drug Standard Control Organization (CDSCO) has recently made a change to how safety reports for medical devices and…

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CDSCO Update: New Online PSUR Guidelines in India
CDSCO Test License for Medical Devices in India

CDSCO Test License for Medical Devices in India

Chapters IV and V of the MDR 2017 provide detailed guidelines for manufacturers and importers seeking to manufacture or import…

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NSWS portal: A Single Window for Central Government Approvals

The Central Government has launched the National Single Window System (NSWS) portal for businesses/investors seeking to enter or operate in…

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NSWS portal: A Single Window for Central Government Approvals
CDSCO Approval Process for Medical Devices without predicate in India

CDSCO Approval Process for Medical Devices without predicate in India

The Indian medical device market is growing rapidly, and the current medical device market size is estimated at $11 billion…

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Ensuring Quality in Healthcare: The Role of BIS Standards for Medical Devices

Introduction: In the ever-evolving landscape of the healthcare industry, ensuring the quality and safety of medical devices is paramount. To…

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Ensuring Quality in Healthcare: The Role of BIS Standards for Medical Devices
6-Month Extension Announced for Class C and Class D Medical devices

6-Month Extension Announced for Class C and Class D Medical devices

On October 12, 2023, the CDSCO released a circular, extending the deadline by six months for manufacturers and importers dealing…

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WPC ETA Certification – Must for Wireless Medical Device

Introduction: Medical devices incorporating wireless technologies require WPC Equipment Type Approval (ETA) certification to be imported or sold in India.…

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WPC ETA Certification – Must for Wireless Medical Device
The Vital Role of Post-Marketing Surveillance for Medical Devices

The Vital Role of Post-Marketing Surveillance for Medical Devices

Introduction: The use of medical devices has improved healthcare enormously. However, like any technology, medical devices also carry risks. These…

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Medical Device Labelling: Ensuring Clarity and Safety

Introduction: In the world of healthcare, medical devices play a crucial role in diagnosis, treatment, and patient care. At the…

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Medical Device Labelling: Ensuring Clarity and Safety
Medical Device Grouping: An Effective Regulatory Approach

Medical Device Grouping: An Effective Regulatory Approach

Introduction: In the dynamic world of medical devices, regulations play a critical role in ensuring patient safety and product efficacy.…

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Understanding the Validity and Renewal of CDSCO Medical Device Import License

Introduction : As per the Medical Device Rule, 2017, the medical device import license in India needs to be renewed…

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Understanding the Validity and Renewal of CDSCO Medical Device Import License
Transitioning to Full Licensing: Class C and D Medical Devices in India

Transitioning to Full Licensing: Class C and D Medical Devices in India

Introduction: On April 12, 2023, the Central Drugs Standard Control Organization (CDSCO) of India released a circular reminding Indian manufacturers…

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Understanding Post-Approval Changes in Medical Devices: A Comprehensive Guide

Introduction : The introduction of a medical device into the market is a complex process that starts with necessary approval…

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Understanding Post-Approval Changes in Medical Devices: A Comprehensive Guide
New Medical Device Rules in India: Registration Certificate for Sale

New Medical Device Rules in India: Registration Certificate for Sale

The Indian medical device industry is currently experiencing a significant transformation with the Ministry of Health and Family Welfare (MoHFW)…

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Registration Process for Class A Non-Sterile and Non-Measuring Medical Devices in India | An Overview

Medical devices play a crucial role in maintaining the health and well-being of people. The number of medical devices on…

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Registration Process for Class A Non-Sterile and Non-Measuring Medical Devices in India | An Overview
How to get medical device manufacturing license in India?

How to get medical device manufacturing license in India?

A CDSCO medical device manufacturing license is required for companies that manufacture medical devices in India. Obtaining a manufacturing license…

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The Complete Guide to CDSCO Medical Device Registration

The Complete Guide to CDSCO Medical Device Registration The Indian healthcare sector is rapidly expanding and is expected to reach…

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The Complete Guide to CDSCO Medical Device Registration