Regulatory Solutions India

 India
RSI- A leading regulatory Consultant in India provides all regulatory consulation that you need for cosmetic and medical device industry. https://www.regulatory-solutions-india.com/

Regulatory Solutions India's articles

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How to Choose a Medical Device Regulatory Consultant in India ?

Choosing the right regulatory consultant for your medical device in India is crucial to ensure compliance with local regulations and smooth market entry. Here’s a guide to help you make an informed decision. Understanding Regulatory Consulting Services Regulatory consulting services assist companies in navigating complex regulatory requirements for medical devices. These services include preparing documentation, obtaining necessary […]
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Streamlining Medical Device Safety: CDSCO’s New Online PSUR Guidelines in India

Introduction: CDSCO has revolutionized safety reporting for medical devices and in-vitro diagnostic devices in India. As of March 19, 2024, all manufacturers must submit safety reports online through the Sugam portal. This blog explores the significance of these reports, their components, and the streamlined submission process. What is Periodic Safety Update Reports (PSURs)? Periodic Safety Update […]
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CDSCO Approval Process for Medical Devices without Predicate | RSI

Introduction: The landscape of the Indian medical device market is rapidly evolving, with current estimates placing its size at $11 billion, expected to surge to $50 billion by 2025. This growth presents a golden opportunity for manufacturers and importers to introduce their medical devices into India. However, for devices without a predicate, the regulatory approval […]
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Navigating Quality Standards: BIS Certification for Medical Devices in India

Introduction:In the world of healthcare, making sure medical devices are top-notch in quality and safety is super important. This guide is all about how the Bureau of Indian Standards (BIS) ensures these medical devices meet the right standards. We’ll dive into what these standards mean, why they’re essential, and how they help both the makers and the […]
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CDSCO’s Extension: Grace Period for Class C and Class D Medical Devices

Introduction: The CDSCO recently extended the deadline by six months for manufacturers and importers dealing with non-notified Class C and Class D medical devices. Originally scheduled for mandatory licensing from October 1, 2023, this extension aims to facilitate a smoother transition. Let’s explore the CDSCO circular and the approval procedures for these devices. Addressing Industry Concerns: The […]
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Welcome to Regulatory Solutions India (RSI) – Your Trusted Regulatory Consultant in India

Unlock the Indian market potential with ease. RSI, established in 2011, stands at the forefront of regulatory consulting, boasting a track record of over 450 successful product registrations in India. Our expertise spans various domains, including medical devices, IVDs, and cosmetics, across 25+ categories. From stents to orthopedic implants, from surgical dressings to hypodermic syringes, we've […]
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Regulatory Solutions India (RSI) — Your Trusted Regulatory Consultant in India

Unlock the Indian market potential with ease. RSI, established in 2011, stands at the forefront of regulatory consulting, boasting a track record of over 450 successful product registrations in India. Our expertise spans various domains, including medical devices, IVDs, and cosmetics, across 25+ categories. From stents to orthopedic implants, from surgical dressings to hypodermic syringes, we’ve […]
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The Importance of WPC ETA Certification for Wireless Medical Devices in India

The Indian medical device market is growing rapidly, offering immense opportunities for companies worldwide. However, launching wireless medical products in India requires obtaining mandatory approval called ETA certification from the Wireless Planning and Coordination (WPC) wing of the Department of Telecommunications. In this blog, I will provide a deep dive into ETA certification — what it means, […]
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Enhancing Patient Safety: The Significance of Post-Marketing Surveillance for Medical Devices

Medical devices have revolutionized healthcare, but they also come with inherent risks. Post-marketing surveillance (PMS) is a critical component of ensuring patient safety once these devices are in clinical use. India, through the Materiovigilance Programme (MvPI), is at the forefront of strengthening PMS efforts. What is Post-Market Surveillance?Post-market surveillance (PMS) involves the continuous monitoring of a medical […]
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Medical Device Labelling: Ensuring Clarity and Safety

Medical device labelling is integral to patient safety and effective healthcare delivery. As per Chapter VI of India’s Medical Device Rules 2017, medical device labels must provide essential information to facilitate proper identification, handling, and usage. Key Labelling Requirements: The regulations mandate including specific details on medical device labels: Identification details like name, batch number, or […]
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Medical Device Grouping: Simplifying Regulation for Enhanced Efficiency

In the intricate realm of medical devices, robust regulations stand as sentinels of patient safety and product efficacy. Recognizing the imperative to streamline the licensing process, the Indian Government introduced the concept of “medical device grouping” under the Medical Device Rule, 2017 (MDR 2017). This innovation aims to expedite the licensing procedure, rendering it more […]
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How to Obtain CDSCO Medical Device Import License in India ?

Introduction: The Indian healthcare sector is experiencing rapid growth, with the medical device market expected to reach $280 billion by 2025. Despite this, India still relies on imports for approximately 70% of its medical devices. To regulate this sector, the Central Drugs Standard Control Organization (CDSCO) introduced the Indian Medical Device Rules, 2017. This informative […]
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Full Licensing Requirement for Class C and D Medical Devices in India

Introduction: On April 12, 2023, the Central Drugs Standard Control Organization (CDSCO) of India issued a circular reminding Indian manufacturers and importers that all Class C and Class D non-notified medical devices, which currently require mandatory registration, will now need a full license starting from October 1, 2023. This blog aims to provide an overview […]
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Understanding Post-Approval Changes in Medical Devices: A Comprehensive Guide

Introduction: Medical devices are subject to continuous change, which is an essential part of the development process. Sometimes, after the approval of the licensing authority, changes are made to the medical device to improve its performance, quality, safety, and effectiveness. These changes are known as Post-Approval Changes in Medical Devices. This guide will provide an […]