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What is Medical Device Biocompatibility? 5 Common Tests
Medical devices play a pivotal role in the healthcare sector. Hence, device safety is a key consideration for ensuring patient safety. Biocompatibility is the cornerstone of medical device safety. It ensures that a device performs its intended function without causing...
MDEL Annual License Review: Everything You Need to Know
To continue operating under an active MDEL, holders must apply for an annual license review (ALR). This renewal is mandated under Section 46.1 of the Canadian Medical Devices Regulations. In this blog, we have discussed the MDEL annual license review process....
Health Canada Updates: 4 Proposed Changes in Phase II of MDEL
Canada has classified medical devices into four classes based on risk level associated with the device. Although Class I medical devices are lowest risk devices, companies are still required to abide by certain regulatory obligations. To operate legally in Canada,...
Health Canada MDL Technical File Preparation: 7 Pro Tips
Health Canada is the apex regulatory body for ensuring safety, effectiveness, and quality of medical devices entering the Canadian market. Complying with Health Canada medical device regulations is a must to launch your product in Canada. Moreover, you have to secure...
Separate Provision for Subsequent Importers of Approved Medical Devices
To simplify and expedite the import process for already-approved medical devices and IVDs, CDSCO has implemented a new provision. A circular dated 15.9.25, states that w.e.f 11.9.25 a separate provision for "Subsequent Importers" of already-approved medical devices...
Health Canada Medical Device Labelling Guidelines: A Guide
Health Canada medical device labelling guidelines are designed to ensure the device’s use is clearly understood by users. These guidelines help patients and practitioners use the device as intended. Hence, the medical device labelling guidelines have a role in device...
What are the Differences Between Health Canada MDL and MDEL?
Health Canada issues two types of licenses, medical device establishment licence (MDEL) and medical device licence (MDL). Medical devices are categorised into Class I, II, III, and IV, based on risk level. It is important to determine the class to which your medical...
A Guide to CE Mark For Medical Devices: What, How, & Why
To secure CE mark, the manufacturer is expected to ensure all EU-wide requirements for the medical device have been complied. If the device complies with strict safety, health, and environmental protection benchmarks, it may be granted the CE mark certification....
Dynamic Risk Management for Software-Enabled Medical Devices
An increasing number of software-enabled medical devices are being used in the healthcare industry. Manufacturers face unique challenges with the rise in use of software-enabled medical devices. Rapid design iterations, cybersecurity threats, integration of software...
Medical Device Packaging Shelf Life Testing and Validation
Medical device packaging aims to ensure sterility, safety, and effectiveness of the device from manufacture to the point of use. A tiered system of packaging is used for medical devices. The packaging level is defined by the proximity to the device. Primary...
8 Common Medical Device Biological Testing Methods
Medical device biological testing is a critical part of the regulatory approval process. In this blog, we have discussed the various medical device biological testing methods. Additionally, we have mentioned the parameters used to choose the appropriate test method...
IOL Cast Moulding Technology and Regulatory Guidelines
Intraocular lenses (IOLs) are tiny artificial lenses implanted inside the eye during cataract surgery. They are used to replace the natural lens that become cloudy as we age. In this blog, we will discuss why IOL cast moulding technology is becoming the gold...
5 Key Elements of an Effective CAPA System
An effective corrective and preventive action (CAPA) system is the backbone of a robust quality management system (QMS). It ensures that systemic issues are not only corrected but prevented from recurring. An effective CAPA system improves product quality and customer...
Role of Regulatory Affairs in the Medical Device Industry
The regulatory affairs team creates tailored regulatory strategies to ensure smooth market entry and compliance with international standards. They analyze product classification, applicable regulatory guidelines, and submission requirements. Moreover, they prepare and...
Role of Cleanrooms in Manufacturing Sterile Medical Devices
Cleanrooms have a vital role in maintaining the controlled environments necessary for manufacturing sterile medical devices. They offer a sterile and specialised environment. Medical device manufacturers will have to establish effective clean rooms to maintain a...
How to Import Medical Devices from Japan? Comprehensive Guide
Japan is a top global exporter of medical devices, especially in diagnostic and imaging equipment. Japan has a reputation for manufacturing high-quality and reliable products. India has a growing medical device market and increasing demand for advanced healthcare...
How to Import Medical Devices from USA? Your Guide
Planning to import medical devices from USA? With over 27 years of experience and more than 600 clients, we have extensive knowledge of the CDSCO regulations. We will leverage our expertise and industry knowledge to help you easily get the CDSCO MD 15 import license....
Why Does Strategic Timing of US FDA 510(k) Submission Matter?
Compliance with US FDA regulations is mandatory for marketing and distributing medical devices in the U.S. The US FDA 510(k) approval process authorizes the marketing of medical devices in the US. Timing, completion, and accuracy are of paramount...
Regulations for Manufacturing Wearable Defibrillators: A Guide
Wearable defibrillators are non-invasive lifesaving medical devices. Hence, their manufacturing process is strictly regulated. In this blog, we have discussed the wearable defibrillator manufacturing process. Additionally, we have highlighted the regulations for...
How to Import Medical Devices from UK? Comprehensive Guide
Currently, India's medical device market heavily relies on imports. UK is among the top countries from which India imports medical devices. The demand for UK-imported medical devices is strong and projected to grow. Furthermore, the India-UK Free Trade Agreement (FTA)...
10 Key Components of Medical Device Quality Assurance System
Quality assurance (QA) has a pivotal role in ensuring the safety, efficacy, and reliability of medical devices throughout their entire lifecycle. It covers conception and development to manufacturing, distribution, and post-market surveillance of medical devices....
10 Common Quality Challenges in the Medical Device Industry
Quality cannot be compromised in medical device production. Maintaining consistent and high product quality is of paramount importance in the medical device industry. Common quality challenges in the medical device industry are production, technical, regulatory, and...
How to Import Medical Devices from China? A Step-by-step Guide
India is aiming to reduce its import dependency and boost domestic medical device manufacturing. However, a major supply of India’s medical device requirements comes from China. India is still heavily import dependant for fulfilling its medical device demands....
9 Key Components of a Clean Room & Their Functions: A Guide
Cleanrooms are specialized and controlled environments vital for the manufacturing and packaging of medical devices. They are designed to reduce airborne particles, microbes, and other contaminants that could compromise device quality, efficacy, and safety. This...
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...