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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...
CDSCO License for Foreign Medical Devices Manufacturers
With growing healthcare infrastructure and increasing demand for advanced medical technologies, the Indian medical device market provides considerable opportunities. India’s healthcare sector is one of the fastest-growing industries, with the medical device market...
New Investment Opportunities in Medical Devices Industry
Medical devices form the backbone of the healthcare industry. They are constantly being used to diagnose, treat, and monitor patients. The medical device industry is a dynamic sector buzzing with new investment opportunities. We have highlighted some key medical...
Wearable Technology in Healthcare Sector: Regulatory Guidelines
Wearable technology has revolutionised healthcare industry. Wearable technology in healthcare industry is enabling continuous and real-time monitoring, thereby empowering both patients and healthcare providers. They are having a considerable impact on improving lives,...
Health Canada Medical Device Approval: 8 Common Mistakes
If you are planning to sell medical devices in Canada, you will be required to mandatorily secure an approval. Navigating the Health Canada medical device regulations can be a cumbersome task. We have listed some of the mistakes encountered while securing the Health...
US FDA Regulatory Pathways for New Medical Devices
US FDA has stringent regulations for medical devices entering the US market. For launching a new medical device in US, you need to mandatorily comply with all FDA medical device regulatory guidelines. Additionally, you need to secure the applicable approval type for...
5 Common SFDA Medical Device Registration Challenges
Saudi Arabia is the gateway to accessing one of the fastest-growing medical device markets in the Middle East. Hence, entrepreneurs are aiming to reap the potential of the Saudi medical device market. Regulation of medical devices is a necessary requirement to ensure...
SFDA Medical Device Packaging, Assembly, And Sterilization Guide
Saudi Food and Drug Authority (SFDA), a government regulatory body, is responsible for ensuring safety and efficacy of medical devices. This regulatory body ensures the medical devices are at par with industry quality benchmark. The main goal of SFDA is to protect...
SFDA Significant and Non-Significant Changes: Detailed Guide
Saudi Food & Drug Authority (SFDA) is the regulatory authority for medical devices sold and distributed in Saudi Arabia. Prior to marketing your medical devices, you need to register your product with SFDA. Compliance with SFDA regulatory guidelines for medical...
Why Should You Hire an SFDA Regulatory Consultant?
The Saudi Arabian medical device market has a promising future. Hence, it is attracting an increasing number of medical device manufacturers. However, for entering this market, compliance with stringent Saudi Food and Drug Authority (SFDA) regulations is mandatory....
How to Register a Medical Device in Saudi Arabia?
The Saudi Arabia medical device regulations are dynamic and are constantly being updated to protect patient health. We have prepared this detailed guide to help you easily register your medical device in Saudi Arabia. Why should you choose Saudi Arabia for starting a...
Easily Get Health Canada Medical Device Registration
Health Canada reviews medical devices for safety, effectiveness, and quality before authorizing them for sale in Canada. Canada has a stringent medical device regulatory system, as it prioritises patient safety and effective healthcare delivery. If you are planning to...
Get Health Canada Medical Device Licence (MDL)
Medical devices have an indispensable role in the healthcare industry. They need to be strictly monitored and regulated for safety, efficacy, and quality to deliver high quality healthcare to patients. Their regulation plays a vital role in safeguarding the healthcare...
How to Easily Register Medical Devices in Canada? Your Guide
The Canadian medical device industry is evolving and dynamic with considerable growth potential. Entrepreneurs are showing growing interest to enter the Canadian medical device market. We have prepared this guide to help you easily register medical devices in Canada....
Regulations for Class I Medical Devices in Canada
Canada has well-balanced and strict regulations for medical devices entering its market. Health Canada regulates all medical devices in the Canadian medical device market. Health Canada’s medical devices regulations establish a comprehensive regulatory framework for...
What is the difference between US FDA 510(k) and PMA? A Guide
All medical devices entering the US market must comply with the regulatory requirements formulated by US FDA. These regulatory requirements are in place to ensure safe, effective, and high-quality medical devices reach the patients. The regulatory pathway required...