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10-Step Guide to Hassle-free Integration of UDI into QMS
Integrating unique device identification (UDI) into your quality management system (QMS) will enhance traceability, compliance, and operational excellence. UDI will improve efficiency of the medical device supply chain as well as enhance patient safety and post-market...
8 Step Guide to FDA 510(k) Pathway for Unclassified Devices
The primary focus of FDA 510(k) pathway is Class I and Class II medical devices. However, medical devices that lack formal classification may still be eligible for 510(k) clearance. Unclassified devices can still follow the FDA 510(k) pathway, if a legally marketed...
CDSCO Mandates Risk Classification for Class A and B Medical Devices & IVDs
Recently, CDSCO has issued a notice reminding State Licensing Authorities (SLAs) that manufacturing licenses for Class A and B medical devices and IVDs must be issued only after verifying the device’s risk classification in the CDSCO’s official list. Notably, issuance...
Understanding the MDSAP Audit Cycle: A Comprehensive Guide
The Medical Device Single Audit Program (MDSAP) is one comprehensive audit for meeting the regulatory requirements of multiple participating countries. Achieving regulatory harmonization across different regulatory industries will help manufacturers easily launch...
IVD Technology Transfer in India: Key Components & Regulations
IVD technology transfer is crucial for manufacturers transitioning IVDs from development to full-scale production or relocating manufacturing between facilities. A successful transfer demands meticulous planning, comprehensive documentation, and alignment with...
10 Best Practices for Post-Market Surveillance for SaMD
Post-market surveillance (PMS) for software as a medical device (SaMD) is a critical regulatory and operational requirement. It ensures ongoing safety, performance, and compliance once the product is launched in the market. SaMDs are reshaping modern healthcare. They...
Additive Manufacturing in Medical Device Industry: The Future
Additive manufacturing is revolutionizing the medical device manufacturing industry. It can be used to create complex, customized, and patient-specific products at unprecedented speed and precision. Additive manufacturing is opening new possibilities for medical...
How to Prepare for a Successful MDSAP Audit? Your Guide
Preparing for a successful medical device single audit program (MDSAP) audit requires strategic planning, robust documentation, and cross-functional alignment. For manufacturers seeking to demonstrate regulatory compliance across multiple jurisdictions, MDSAP is a...
Global Cosmetic Regulation: Heavy Metal Limit for Cosmetics
Heavy metals, such as lead, mercury, arsenic, cadmium, and antimony, are considered toxic contaminants in cosmetics. While some may occur as unavoidable impurities due to environmental ubiquity, worldwide regulatory bodies enforce limits to mitigate health risks. To...
An 8-Step Guide to Selecting a US FDA agent for Your Company
A U.S. FDA agent is a designated representative required for foreign companies that manufacture, process, or distribute FDA-regulated products. These products, such as medical devices, drugs, or food, should be intended for import into the United States. We have...
US FDA Medical Device Registration and Listing: Complete Guide
FDA medical device registration and listing is a mandatory annual process. Medical device companies are required to register their facilities and list their specific products with FDA. It is a regulatory requirement for any company that manufactures or imports devices...
US FDA 510(k) Third Party Review: Everything You Need to Know
The FDA 510(k) Third Party Review Program is a voluntary alternative review pathway. It allows accredited third-party organizations to review certain low- to moderate-risk medical device submissions instead of the FDA itself. The Third Party Review process helps...
A Guide to US FDA De Novo Submission Process and Timeline
US FDA De Novo submission is a regulatory route for low to moderate-risk medical devices that lack a predicate device. It enables manufacturers to classify novel devices into Class I or Class II. This allows the device to be marketed in the US. Additionally, it can...
US FDA IVD Classification System: A Comprehensive Guide
In vitro diagnostics (IVDs) have a vital role in improving patient outcome and public health surveillance. IVDs are used to detect diseases, monitor health conditions, guide treatment decisions, detect diseases early on, and support precision medicine. Hence, IVDs...
US FDA Medical Device Classification System: Your Guide
The FDA classifies medical devices into three categories based on associated risk level. Each device class requires a different level of regulatory control. These guidelines are in place to ensure the safety and effectiveness of the device. Hence, manufacturers...
US FDA 510(k) Submission for Non-Active Devices: 7-Step Process
Non-active devices form the backbone of clinical practice. They are often simple in design but require rigorous validation to ensure safety, especially when used invasively or for long-term. For non-active medical devices, the 510(k) submission process is rigorous but...
FDA 510(k) Submission for Active Devices: Need & Requirement
Owing to their reliance on external energy sources, active medical devices pose moderate risk to the patients and users. Hence, they have to be regulated accordingly. They fall under the purview of FDA 510(k). Manufacturers will have to demonstrate their device is...
7 Reasons to Hire an US FDA 510(k) Consultant for SaMD
Similar to other medical devices, SaMDs will also have to comply with US FDA regulations to be launched in US. Navigating the US FDA regulations for SaMDs can be a daunting task. Hiring an US FDA 510(k) consultant for SaMD can streamline the application process. What...
Get CDSCO Import License for Hair Removal Lasers & Skin Laser
India’s laser hair removal industry is booming at an unprecedented rate. Growth of the grooming industry, rising awareness of aesthetic treatments, and technological advancements are all driving the growth. CDSCO regulates the laser hair removal and skin laser...
Best US FDA 510(k) Consultant Service for Medical Devices
Are you a medical device manufacturer seeking FDA 510(k) clearance? Well, you have landed in the right place. We are a renowned US FDA 510(k) consultant. Our team will help you navigate the FDA’s regulatory requirements with ease. Our aim is to reduce the time to...
What is the US FDA 510(k) Submission Process? Your Guide
US FDA 510(k) submission is a premarket notification required for medical devices intended for U.S. market entry. This pathway is essential for devices that are not exempt from FDA 510(K) and is not already legally marketed. Additionally, it is required for devices...
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...