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What is ETO Sterilization for Medical Devices? A Detailed Guide
Proper sterilization of medical devices is a necessity to reduce chances of infection caused by these devices. In this blog, we have discussed ETO sterilization for medical devices, which is a commonly used medical device sterilization method. What is medical device...
How to Avoid Medical Device Product Recalls? 8 Strategies
Medical device product recalls are part of regulatory oversight for ensuring the best quality devices are available in the market. Getting notified by regulatory authorities for product recall will tarnish the medical device manufacturer’s image. Hence, we have...
8 Common Regulatory Pitfalls in Medical Device Labelling
Medical devices should be properly labelled so that they are used as intended. This increases safety and reduces risk. Correct labeling of medical devices empowers healthcare professionals and patients to make informed decisions. Mistakes in medical device...
7 Benefits of Risk Management in Medical Device Production
Risk management in medical device production is a systematic, dynamic, continuous, and multifaceted process. In this highly competitive medical device landscape, implementing risk management strategies is not only about compliance but also a necessity. Manufacturers...
ISO 13485 Certificate for Low-To-Moderate Risk Devices
The ISO 13485 guidelines provide a structured framework for establishing a quality management system that meets global standards. A properly designed and implemented QMS will ensure every step in the medical device production process is controlled and monitored. An...
12 Common Pitfalls in Medical Device Regulatory Submissions
We have discussed some of the common mistakes in medical device regulatory submissions. Understanding these common pitfalls will help streamline your application and improve your chance of approval. Additionally, we have provided some tips for avoiding these...
India Emerging as the Powerhouse in Global Medical Device Industry
India is slowly moving towards achieving its goal of becoming a global medical device industry powerhouse. Currently, India ranks among the top 20 medical device markets globally. More than 750 medical device manufacturers operate in India. With its robust...
UP Government Scheme to Promote Medical Device Manufacturing in Greater Noida
The Uttar Pradesh government has launched an initiative to promote medical device manufacturing in Greater Noida. The government aims to make Uttar Pradesh a world-class hub for manufacturing medical devices. This initiative is expected to attract significant...
Top 11 Medical Device Trends to Watch in 2025
The medical device industry is poised for significant growth and transformation. As we move into the second leg of the year 2025, we have highlighted some medical device trends to watch. By embracing these new trends, the medical device industry can continue to...
Regulations for Transdermal Patches: Key Aspects & Challenges
Transdermal patches are an evolving technology in the field of drug delivery. They lie at the cross section of drugs and device. These patches are one of the most innovative drug delivery systems in modern healthcare. Transdermal patches are non-invasive and easy to...
CDSCO Regulations for Importing Cosmetics into India: A Guide
Central Drugs Standard Control Organisation (CDSCO) stringently regulates all cosmetics being imported into India. Cosmetics cannot be imported into India without the cosmetics import registration certificate (COS 2 license). Only cosmetics products satisfying the...
4-Step Guide to Navigating Regulations for Dental Scanners
By replacing traditional moulds, dental scanners have revolutionised modern dentistry. To ensure patient safety, dental scanners are strictly regulated. We have prepared a step-by-step guide to help you easily navigate the regulations for dental scanners. What are...
5 Step Guide to Import Cosmetics from Korea into India
Korean cosmetics products are experiencing a meteoric rise in India. Indian consumers are becoming increasingly aware of skincare needs and the ingredients in their products. Korean cosmetics products, popularly known as the K-beauty products, are rapidly capturing...
How To Easily Get MDSAP Certification? A Step-by-step Guide
Medical device single audit program (MDSAP) aims to accelerate international medical device regulatory harmonization. This streamlined, efficient, and effective regulatory model promotes worldwide alignment of international regulatory requirements. MDSAP helps medical...
Medical Device Single Audit Program: MDSAP Consultation Service
Medical device single audit program (MDSAP) is a global initiative designed to streamline the regulatory compliance process in participating countries. US, Canada, Brazil, Japan, and Australia are MDSAP members and participating countries of the program. We at...
How to Import Cosmetics from USA to India?
Imported cosmetics from USA are in high demand in India. Planning to venture in to imported cosmetics business? Well, this blog is curated just for you. In this blog, we have discussed how to secure the license to import cosmetics from USA to India. CDSCO regulations...
Global Regulations for Custom-Made Medical Devices
Custom-made medical devices have a crucial role in modern healthcare system. Owing to their unique nature, custom-made medical device manufacturers may face several regulatory challenges. This guide will help you navigate the top global regulations for...
Cosmetics Labelling Guidelines: 16 Mandatory Requirements
CDSCO has laid down stringent guidelines for cosmetics products entering the Indian market to ensure consumer safety. Additionally, it has formulated guidelines for cosmetics product labels. In India, cosmetics product labels are governed by the Drugs & Cosmetics...
12 Tips for Preparing Medical Device Technical File
A medical device technical file is a structured dossier that contains all essential documentation required for demonstrating regulatory compliance. Additionally, it is used to demonstrate the medical device’s safety, performance, and quality to regulatory authorities....
How to Import Cosmetics from China to India? Your Guide
Chinese cosmetics offer a wide range of products and are at par with global trends. Additionally, cruelty-free, eco-friendly, and vegan Chinese cosmetics are available, which is making them in demand in India. Chinese cosmetics are especially attractive to Indian...
ISO 13485 Guidelines: 8 Steps to Securing ISO 13485 Certification
Medical device manufacturers, suppliers, and service providers need to have a clear understanding of ISO 13485 guidelines. ISO 13485 is the internationally recognized standard for quality management systems (QMS) for the medical device industry. In this blog, we have...
How to Secure CDSCO Import License for Lipsticks? COS-2
Lipstick is a staple cosmetic product. The demand for imported lipstick in India is on a steep rise. Increase in disposable incomes, influence of beauty trends driven by social media, and expanding e-commerce footprint are driving the growth. Furthermore, a...
10 Benefits of Automating Medical Device Regulatory Compliance
With multiple complex regulatory compliance requirements, automation will be beneficial for managing regulatory compliance in medical device industry. By automating medical device regulatory compliance, companies will be placed in an advantageous position. Medical...
9 Key Differences Between Clinical Study and Clinical Evaluation of Medical Device
Clinical study and clinical evaluation of medical devices are common regulatory requirements for market approval. These terms are often used interchangeably. However, they have different purposes, are used in different situations, and have different protocols. Hence,...
Correction, Corrective Action, and Preventive Action (CAPA): Scope & Differences
Having a robust correction, corrective action, and preventive action system will help ensure regulatory compliance. Hence, most regulatory guidelines recommend implementation of a CAPA system. Our blog post on correction vs corrective action vs preventive action will...
6 Differences Between US FDA De Novo and FDA 510(k) Pathways
The US FDA offers multiple regulatory pathways for medical devices entering its market. In this blog, we have highlighted the differences between US FDA De Novo and FDA 510(k) pathways. FDA De Novo and FDA 510(k) To understand the differences between FDA De Novo and...
5 Step Guide to Manufacturing Dental Cement: Global Regulations
Dental cements are materials used in dentistry to bond restorations, fill cavities or act as liners, and provide temporary/permanent adhesion. Hence, they have a crucial role in modern dentistry. As dental cements are of pivotal importance in dentistry and are...
What are Good Documentation Practices (GDP)? Basics & Pro Tips
Good documentation practices (GDP) describe best practices for creating and maintaining documentation in both paper and electronic format. These practices are used in pharmaceutical industry, medical device industry, and laboratories. It is basically a set of good...
Difference Between CE mark and FDA Approval: Detailed Guide
In this blog, we have highlighted the key differences between CE mark and FDA approval. Additionally, we have discussed which is easier to secure and the required timelines for approval. This blog will be especially helpful for those entering new international...
Laboratories for IVD Performance Evaluation: Updated List
Given their important role in healthcare industry, in-vitro diagnostic devices (IVDs) have to be strictly regulated and monitored. CDSCO has formulated strict guidelines for IVDs in India. This apex regulatory body is aimed at enforcing these regulations to monitor...
Kerala’s Medtech Industry Set to Become a Global Hub in 5 Years
With skilled professionals and strong academic and research infrastructure supporting innovation, Kerala’s medtech industry is rapidly growing. Additionally, the Kerala government is providing considerable support to the medical device industry. Withing 5 years,...
Get CDSCO License for Manufacturing Hospital Beds in India
Hospital beds are specialized beds that are designed for use in healthcare facilities, like hospitals, clinics, and long-term care centres. Medical-surgical bed, hydraulic bed, manual bed, electric bed, bariatric bed, birthing bed, orthopedic traction bed, etc....
Medical Devices Design and Development: Key Points & Hurdles
Medical devices design and development is an intricate procedure with multiple parameters to keep in mind. Moreover, medical devices are strictly regulated. Hence, regulatory compliance should be at the core of the design and development process. ISO 13485:2016...
Get CDSCO License for Hospital Furniture in Delhi
Hospital furniture is a staple requirement in any healthcare setting. As they impact how patient care is delivered and patient safety, they have to regulated similar to medical devices. Hospital furniture is in high demand in Delhi. Hence, medical device companies are...
India’s First Indigenous MRI Machine to Reduce Treatment Costs
Most critical care equipment used in India, such as ICU devices, robotic surgery tools, and MRI scanners, are currently imported. Hence, most of these devices are inaccessible, making healthcare unaffordable for many. India is aiming to reduce its import dependency in...
India will Reduce Import Duties on PLI-Covered Medtech
The Indian medical device market is dynamic with high potential. In a recent policy update, India has stated it will reduce import duties on medical devices covered by PLI schemes. This update can be attributed to the new free trade agreement (FTA) with the United...
CDSCO Loan License Rules Relaxed for Sterilisation of Medical Devices
Proper sterilization of medical devices is necessary to reduce chances of infection caused by using these devices. A contaminated medical device will lead to device-induced infection, thereby do more harm than good to the patient. Hence, while manufacturing medical...
CDSCO GCP Guidelines: Good Clinical Practice Guidelines
Good clinical practice (GCP) provides guidelines for designing, conducting, recording, and reporting clinical trials that involve human participants. GCP sets standards that need to be followed by conducting clinical trials. It ensures that the rights, safety, and...
How to Deal with Medical Device Industry Quality Challenges?
In this blog, we have discussed common medical device industry quality challenges. Additionally, we have provided some tips on how to overcome them. What are medical device industry quality challenges? Medical device industry quality challenges are technical,...
CDSCO License for Clinical Chemistry Reagents or Kits
Clinical chemistry reagents and kits are considered in-vitro diagnostic devices (IVDs) per CDSCO guidelines. They are regulated by the Medical Device Rules, 2017. To manufacture or import clinical chemistry reagents and kits, you need to comply with CDSCO...