Regulatory Solutions India
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
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Regulatory Solutions India
Nov 53 min read
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.
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Regulatory Solutions India
Sep 244 min read
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...
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Regulatory Solutions India
Aug 204 min read
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...
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Regulatory Solutions India
Jul 164 min read
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...
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Regulatory Solutions India
Jun 132 min read
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...
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Regulatory Solutions India
May 212 min read
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...
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Regulatory Solutions India
May 132 min read
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,...
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Regulatory Solutions India
Apr 182 min read
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...
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Regulatory Solutions India
Mar 152 min read
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...
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Regulatory Solutions India
Feb 202 min read
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...
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Regulatory Solutions India
Jan 82 min read
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...
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Regulatory Solutions India
Dec 6, 20232 min read
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...
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Regulatory Solutions India
Nov 27, 20232 min read
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...
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Regulatory Solutions India
Nov 9, 20232 min read
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...
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Regulatory Solutions India
Oct 17, 20232 min read
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...
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Regulatory Solutions India
Sep 8, 20231 min read
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...
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Regulatory Solutions India
Aug 22, 20232 min read
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...
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Regulatory Solutions India
Jul 20, 20233 min read
CDSCO Medical Device Import License Renewal
The Medical Device Rule of 2017 stipulates that the medical device import license in India must be renewed every five years from the date...
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Regulatory Solutions India
Jun 22, 20232 min read
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...
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