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Exploring Medical Accessories: Understanding Accessories to Medical Devices in India
In the rapidly evolving Indian medical device industry, regulatory compliance is essential not just for primary devices but also for...
Regulatory Solutions India
Jun 233 min read
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Regulatory Pathway for In vitro diagnostics (IVD)
Registration in India: IVDs  have become integral components of modern healthcare across the globe to support the diagnosis, monitoring,...
Regulatory Solutions India
May 13 min read
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A Step-by-Step Guide to EPR Registration and EPR Certification in India
Get a step-by-step guide to EPR Registration & EPR Certification in India. Ensure compliance with expert Regulatory Solutions.
Regulatory Solutions India
Mar 113 min read
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Requirements of Labeling of Medical Devices in India w.r.t. MDR 2017 & Amendments
Get a detailed overview of medical device labeling requirements in India as per MDR 2017 & latest amendments.
Regulatory Solutions India
Feb 52 min read
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How Regulatory Reporting Can Help in Medical Device Introduction in India
The Indian medical device market is growing at an unprecedented rate. Currently valued at approximately USD 12 billion, it is projected...
Regulatory Solutions India
Jan 102 min read
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Mastering Legal Metrology Compliance for Medical Devices: Your Complete Guide
Ensure accurate compliance with legal metrology standards for medical devices. Discover essential guidelines, regulations, and best practice
Regulatory Solutions India
Dec 11, 20242 min read
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Unlocking Compliance: Essential Guide to the Non-Conviction Certificate for Medical Devices in India
This guide provides an in-depth overview of the Non-Conviction Certificate (NCC) required for medical device manufacturers and importers.
Regulatory Solutions India
Nov 5, 20243 min read
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Unveiling the Future of India’s Medical Devices Market: Opportunities and Challenges
In the past decade, the medical devices market in India  has witnessed a remarkable surge, driven by growing demand for various medical...
Regulatory Solutions India
Sep 24, 20244 min read
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Registration of Cosmetics in India
Cosmetics are utilized to improve a person’s appearance. These are used for various beauty treatments such as skin tightening, hair...
Regulatory Solutions India
Aug 20, 20244 min read
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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 by issuing...
Regulatory Solutions India
Jul 16, 20244 min read
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Regulatory Processes for Intraocular Lenses (IOLs) in India
Intraocular Lenses (IOLs) are essential medical devices used in surgeries to replace the eye's natural lens, particularly for cataracts...
Regulatory Solutions India
Jun 13, 20242 min read
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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...
Regulatory Solutions India
May 21, 20242 min read
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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,...
Regulatory Solutions India
May 13, 20242 min read
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Demystifying CDSCO Test License for Medical Devices in India
In India, if you want to make or bring in small amounts of medical devices for certain purposes, you need to follow specific rules...
Regulatory Solutions India
Apr 18, 20242 min read
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Your Guide to the NSWS Portal: Making Business Approvals Easy
Introduction: Starting a business in India just got simpler with the National Single Window System (NSWS) portal. Created by the Central...
Regulatory Solutions India
Mar 15, 20242 min read
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CDSCO Approval Process for Medical Devices without Predicate
Introduction: The landscape of the Indian medical device market is rapidly evolving, with current estimates placing its size at $11...
Regulatory Solutions India
Feb 20, 20242 min read
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BIS Requirements 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...
Regulatory Solutions India
Jan 8, 20242 min read
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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...
Regulatory Solutions India
Dec 6, 20232 min read
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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...
Regulatory Solutions India
Nov 27, 20232 min read
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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...
Regulatory Solutions India
Nov 9, 20232 min read
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