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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...
10 Tips for Outsourcing Regulatory Affairs Team
Outsourcing is becoming increasingly common in pharmaceutical, medical device, and biotechnology, industries, especially in regulatory affairs and pharmacovigilance domains. Large and small companies alike are now turning to outsourcing vendors to manage...
Get CDSCO License for Surgical Instruments for General Use
As general use surgical instruments are intended for general surgical procedures, they have to be strictly regulated. The Central Drugs Standard Control Organization (CDSCO) is at the helm of medical device regulation in India. It aims to protect public health,...
Get CDSCO Radiotherapy Medical Devices License in India
Clinicians use radiotherapy medical devices to deliver targeted and effective cancer treatments. These specialised devices have a vital role in radiation oncology. Radiotherapy medical devices deliver precise doses of radiation to target tumors. They offer precise and...
Get CDSCO Pediatrics and Neonatology Medical Devices License
The Central Drugs Standard Control Organisation is India's top regulatory body for medical devices. Similar to other medical devices, pediatrics and neonatology medical devices are heavily regulated. Securing the CDSCO medical device license is a perquisite for...
Get CDSCO Oncology Medical Devices License in India
With increase in prevalence of cancer in India, the demand for oncology medical devices is increasing. To manufacture or import oncology medical devices, you need to secure the CDSCO medical device license. We have curated this guide to help you secure the CDSCO...
Get CDSCO Nephrology Medical Devices License
Nephrology focuses on kidney health and prevention, diagnosis, and treatment of kidney disease. Nephrologists specialize in the medical management of kidney diseases. Most kidney diseases result from the inability of the kidneys to properly filter waste products...
Get CDSCO Cardiovascular Medical Device License
Cardiovascular medical devices are vital for the diagnosis and treatment of cardiovascular diseases. Given their vital role in the healthcare industry, they have to be stringently regulated. Hence, CDSCO, the apex medical device regulatory body, has formulated...
Snus: Growth Opportunity for Nicotine Manufacturers
Snus and nicotine pouches have become a preferred alternative to traditional smoking for many consumers. Owing to increasing awareness, changing consumer preference, and product innovation, the snus market is rapidly evolving. Thus, globally, snus and nicotine pouches...
Manufacturing Nicotine Pouches and Snus: 6 Key Steps
Nicotine pouches and snus have surged in popularity as alternatives to traditional smoking. With increase in awareness, health-conscious individuals are switching to nicotine pouches and snus. In this blog, we have detailed the process of manufacturing nicotine...
Comprehensive Nicotine Pouches and Snus Project Report
Starting a nicotine pouches and snus manufacturing business is a lucrative option. However, it requires proper planning. Hence, a well-crafted detailed project report can be an invaluable tool for launching a nicotine pouches and snus manufacturing business. The...
Setting Up a Snus Manufacturing Factory in India: A Comprehensive Guide
Snus is a cleaner alternative to cigarettes. It is an excellent choice for individuals who want to enjoy tobacco without smoking. Starting a snus manufacturing business can be profitable, owing to the increasing demand for the product. However, setting up a snus...
Navigating US FDA 510(k) Database: A Step-by-step Guide
The US FDA 510(k) database is a centralized repository of all US FDA 510(k) submissions, clearances, and approvals. Hence, medical device manufacturers are required to refer to the US FDA 510(k) database preparing for FDA 510(k) clearance. Information from the...
CDSCO License for Breathalyser in India: Your Quick Guide
Breathalysers are in high demand in India. Hence, manufacturing or importing breathalyser is a lucrative business opportunity for medical device companies. To ensure poor quality and ineffective products do not reach the Indian market, CDSCO has formulated stringent...
CDSCO License for X-ray Machines in India
Owing to high demand for X-ray machines in India, the Indian government has chalked out stringent regulations for them. Central Drugs Standard Control Organisation (CDSCO) is the apex regulatory body for all medical devices. CDSCO regulations for X-ray machines are in...
CDSCO License for MRI Machines in India
Are you planning to enter the Indian MRI machine market? Are you unclear of the CDSCO regulations for MRI machine? Need guidance and support for securing the CDSCO license for MRI machines in India? Well, look no beyond. We have prepared this guide to help you sort...
CDSCO implements new auto-generated MSC and NCC workflows
The Indian medical device industry is strictly regulated. Medical device manufacturers or importers are required to comply with regulatory guidelines as well secure the necessary certificates and licenses. The regulatory approval pathways for medical devices are being...
CDSCO License for Pulse Oximeters
Pulse oximeters are cheap, easy to carry, safe, and effective blood oxygen saturation level monitoring devices. Precise measurement of oxygen saturation and pulse rate is required, as treatment and diagnosis will depend on these findings. Substandard or low-quality...
Secure US FDA 510(k) Approval for IVDs in a Hassle-free Manner
The US FDA 510(k) approval process authorizes the marketing of IVDs in the US. Through this process the Food and Drug Administration (FDA) evaluates device safety and effectiveness before releasing it in the market. Hence, compliance with US FDA...
ISO 13485 Design Changes: Device Design Change Control
Design changes in medical devices could be modifications made to the design, materials, functionality, or intended use of the device. Moreover, changes in medical device design, manufacturing processes, or regulatory requirements are inevitable in the industry. Hence,...
Revised Risk-Based Classification List for Cardiovascular & Neurological Medical Devices
Central Drugs Standard Control Organisation (CDSCO) is the apex regulatory body for medical devices, drugs, and cosmetics in India. The CDSCO works under the guidance of Medical Devices Rules (MDR), 2017. The Drug Controller General of India (DCGI) is the governing...
Medical Device Transport Validation: Everything You Need to Know
Transport validation is performed to demonstrate the device will remain safe during transportation. Additionally, it ensures the device will perform as intended when they reach the end user. Hence, performing transport validation is a mandatory requirement for most...
Process Validation for Medical Devices: Your Detailed Guide
Process validation for medical devices is performed to demonstrate the finished product will consistently meet quality specifications and user requirements. Hence, regulatory authorities require manufacturers to perform process validation to demonstrate their finished...
Medical Device Packaging Validation: What, Why, & How?
In this blog, we have discussed what is medical device packaging validation and how to perform it. Additionally, we have highlighted the need for performing packaging validation for medical devices. What is medical device packaging validation? Medical device packaging...
Indian Cosmetics Labelling Requirements: A Comprehensive Guide
The Indian cosmetics industry is booming. Hence, all cosmetics products have to be strictly regulated to ensure the safety of Indian consumers. Cosmetics products have to be manufactured by a licensed manufacturer and labelled and packed in accordance with Cosmetics...
Performance Qualification in Pharmaceutical Industry: Your Guide
Performance qualification focuses on the practical application of the pharma equipment and system during manufacturing processes. Certain minor issues do not show up during the operational qualification phase. However, they can cause serious setbacks when the...
Operational Qualification in Pharmaceutical Industry
Operational qualification has a vital role in ensuring high-quality products are being consistently manufactured. It is the third stage in the equipment qualification process. Operational qualification in pharmaceutical industry validates all equipment and sub systems...
Installation Qualification in Pharmaceutical Industry: A Guide
The equipment qualification process in pharmaceutical industry has four stages, design, installation, operational, and performance qualification. Installation qualification is the second stage of the pharmaceutical equipment qualification process. It lays the...
Design Qualification in Pharmaceutical Industry: 10 Tips
Equipment and machinery have an indispensable role in pharmaceutical manufacturing and quality control. Hence, they must pass the design qualification stage fulfilling predetermined user requirement specifications. Design qualification is the first step of the...
Revised Schedule M Deadline Extension Application Process
The CDSCO has now opened the portal for Revised Schedule M deadline extension application. Revised Schedule M deadline extension will be applicable only for small and medium scale businesses having a turnover of less than 250 crore. We have prepared a detailed guide...
DQ, IQ, OQ, and PQ in Pharmaceutical Industry
All pharmaceutical companies are required to abide by stringent regulations to ensure their products are safe and effective. Regulatory authorities specifically emphasize on qualification processes in pharma manufacturing facilities. The process of qualification aims...
20 Key Changes for Ayurvedic Manufacturers in Revised Schedule T Draft
The Schedule T guidelines for ayurvedic medicine manufacturers are being revised to improve the way ayurvedic medicines are manufactured. The aim is to ensure high-quality, safe, and effective ayurvedic medicines are being consistently manufactured. In this blog, we...
GMP and Schedule M Audit Service for Pharmaceutical Facilities
All pharmaceutical manufacturing facilities in India are required to comply with the Schedule M guidelines. The guidelines are intended to change the way pharmaceuticals are manufactured in India bringing them at par with global standards. However, ensuring compliance...
Manufacturing Orthopaedic Implants in India: 5 Key Points
Orthopaedic implants are medical devices commonly used to replace or support damaged or missing bones and joints. Different types of orthopedic implants are used in the healthcare sector. Each implant is designed for specific purposes and anatomical locations....
6 Reasons to opt for Medical Device Contract Manufacturing
In this blog, we have discussed medical device contract manufacturing service. Additionally, we have highlighted why new medical device companies or startups should opt for this service. Furthermore, we have tried to answer some common FAQs. Contract...
Manufacturing MRI Machines in India: Process & License Required
Magnetic Resonance Imaging (MRI) is an excellent non-invasive diagnostic imaging tool. It is used for detection of various diseases by providing precise contrast resolution. Additionally, it is used for treatment monitoring. MRI uses a sophisticated technology....
Common ISO 13485 Audit Mistakes You Can Avoid: 5 Easy Steps
In this blog, we have curated a detailed step-by-step guide to help you avoid the common ISO 13485 audit mistakes. Additionally, we have highlighted why should you bother with ISO 13485 certification and how to secure it. What is ISO 13485? ISO 13485 provides...