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SaMD and SiMD: The Differences and Applicable Regulations
New-age technology and software are revolutionizing healthcare. Currently, software is being used to monitor, diagnose, prevent, manage, and even treat diseases. Software used in healthcare industry are available in different types and forms. The two main categories...
CDSCO License Retention Fee: Mandatory for License Validity
In a recent circular, dated 15.5.24, CDSCO has issued a reminder for license or registration retention under MDR, 2017. This reminder for license and registration certificate renewal requirements is intended for medical device manufacturers, importers, and testing...
Medical Device Process Validation Assures the Device Quality
Regulatory bodies require medical device manufacturers to confirm whether the finished product meets the set regulatory benchmark. Manufacturers need to have strict quality control systems to ensure the devices being manufactured comply with safety and quality...
CDSCO Registration : Start Medical Device Business in India Without CDSCO License
Medical devices form the backbone of the healthcare sector. They are used to perform real time diagnosis of medical conditions as well as treat and monitor them. Medical devices industry is a booming sector in India. There is a high unmet demand for affordable,...
Medical Device Grouping: Simplifying CDSCO License Application
Medical device grouping has been introduced to enhance the license application process in India. Grouping of medical devices expedites and simplifies the CDSCO registration and license application process. In this blog, we will delve into the grouping of medical...
Choosing an Indian Authorized Agent for Medical Devices: A Guide
Authorized agent for medical devices oversees a foreign manufacturer’s regulatory compliance and import operations in India. This blog will guide you on how to choose an “Indian Authorized Agent” for launching your medical device in India. Who is an Indian authorized...
Plant Master File for Medical Devices Registration
Central Drugs Standard Control Organisation (CDSCO) regulates the safety, efficacy, and quality of all medical devices in India. The aim of this regulatory body is to ensure substandard medical devices do not enter the Indian market. To market your medical devices in...
Quality Control in the Medical Device Assembly Process
With advancement in technologies, medical devices have become complicated and intricate with several parts. Manufacturers need to assemble various parts of the medical device to produce a functioning finished product. Hence, medical device assembly quality control...
CDSCO Registration for MRI machine in India
MRI machines play a critical role in enhancing patient care. They help take informed decisions by providing a non-invasive three-dimensional internal view of the human body. In India, awareness regarding the important role ofdiagnostic imaging in early detection is...
BIS Standard for Medical Devices: Everything You Need to Know
India is witnessing a rise in prevalence of chronic, lifestyle, and age-related diseases. The need for advanced and affordable healthcare delivery system and government support are fueling the demand for medical devices. Thus, the Indian healthcare market is thriving....
CDSCO Registration for PPE: Everything You Need to Know
The COVID-19 pandemic highlighted the potential of the Indian medical devices manufacturing sector. During the pandemic, India manufactured and globally distributed medical devices, such as PPE kits, PCR kits, thermometers, and N-95 masks. India’s transformation in...
Guide to Starting a Class A Medical Device Business in India
Medical devices form the backbone of the healthcare sector. Medical devices sector of India has been recognised as the sunrise sector. Given the potential of India’s medical device industry, entities are trying to establish a medical device manufacturing business in...
Indian X-ray Machine Market: Regulations for X-ray Machine
In India, the increasing awareness of benefits of preventive healthcare and early diagnosis is fuelling the demand for medical devices. Improved understanding of the benefits of diagnostic imaging for early detection is driving the growth of Indian X-ray machine...
CDSCO Regulations for Bone Marrow Cell Separator in India
India is witnessing a high prevalence of blood and bone marrow diseases, such as aplastic anaemia, leukaemia, and multiple myeloma. Bone marrow cell separator is a standard laboratory medical device used to diagnose and monitor these diseases. The treatment and...
Medical Devices and IVDs: CDSCO Regulations in India
Medical devices and IVDs are pivotal components of the healthcare sector. They are vital for effective healthcare delivery. Demonstration of safety and efficacy of these devices is crucial prior to marketing these products for use. To ensure improved outcome and...
Dermatological and Plastic Surgery Medical Devices in India
Dermatological and plastic surgery medical devices are in high demand in India. Medical device manufacturing companies are trying to tap into the potential of this sector of the medical device industry. The Central Drugs Standard Control Organization (CDSCO) is the...
CDSCO Registration for Dental Medical Devices in India: A Guide
Dental medical devices include all the tools and equipment used by dental professionals to provide dental treatment. These devices play a vital role in treating dental issues and maintaining oral hygiene. The devices are pivotal for the dental profession. Hence,...
Factors Driving Innovation in the Medical Devices Sector of India
Innovative medical devices enhance the quality of healthcare delivered by providing real-time diagnosis and accurately treating medical conditions. This in turn reduces the overall healthcare cost and hospital stays. In India, there has been a positive shift in...
CDSCO Medical Device MD13 Test License in India: A Detailed Guide
Companies planning to test the quality and safety of medical devices before full-fledged sale need to obtain a test license. A CDSCO test license will enable manufacturers/importers to manufacture or import small quantities of medical devices for evaluation purpose....
21 FAQs on Indian Regulations for Medical Devices
India is a potential global hub for medical devices. Increase in awareness, longevity, and supportive government policies are some of the factors fuelling the demand for medical devices. Hence, entities are trying to tap into the potential of the Indian medical device...
MDR Labelling Requirements for Medical Devices in India
Medical device labelling is essential for conveying vital information related to the medical device. The labels guide users, thereby play a pivotal role in patient safety. Medical devices are one of the pillars of the healthcare industry. Regulatory guidelines are in...
CDSCO Registration for Defibrillators in India
Defibrillators are lifesaving medical devices for emergency situations. With the rise in sudden cardiac arrest incidences in India, defibrillators are in high demand. Medical device companies are viewing this increased demand as a potential business option. With...
CDSCO Regulations for Dialysis Machine Manufacturing in India
In the recent past, there has been an increasing prevalence of chronic and acute kidney failure incidences in India. Dialysis treatment can help improve the quality of life of these patients. However, owing to the paucity of low-cost dialysis machines in India, most...
CDSCO Loan License for Medical Devices
The Medical Devices Act of 2017, provides a regulatory framework governing medical devices marketed in India. The regulations ensure safe, effective, and high-quality medical devices enter the market. This ensures medical devices meeting certain quality benchmark are...
Regulatory Approval for Software as A Medical Device in India
Medical devices are pivotal for diagnosis, treatment, and patient care. Recently, software is being used to monitor, diagnose, prevent, and even treat diseases. New-age technologies, namely wearables and clinical decision-making tools based on artificial intelligence...
Neutral Code for Medical Device Export
India has gained a reputation for manufacturing high-quality medical devices at competitive prices. The country has supportive regulatory requirements, skilled workforce, and cheap labour offering cost advantages. This has made India a potential global hub for...
Sampling of Medical Devices, Drugs, and Cosmetics
Substandard medical devices and counterfeit drugs can have detrimental impact on patients, thereby paralyze the healthcare system. Recently, Central Drugs Standard Control Organization (CDSCO) issued new guidelines for sampling of medical devices, drugs, and...
Medical Devices Quality Control: A Vital Manufacturing Step
The health and safety of individuals depend on the proper functioning of the medical devices. Medical devices are aimed at improving the lives of their users. However, any malfunction of these devices can pose as a serious health threat for individuals and can be life...
An Overview of CDSCO Medical Devices Classification
Medical devices have a vital role in the healthcare industry. These devices are used to diagnose, monitor, and treat patients. India is one of the top global medical device markets. Government bodies usually regulate these devices, used by healthcare professionals, to...
Indian Medical Devices Industry: A Lucrative Sector
Indian medical devices industry, one of the top 20 markets in the world, is the 4th largest market in Asia. Large multinationals and small and medium enterprises (SMEs) comprise the medical devices industry in India. This industry is growing at an unprecedented scale....
14 Tips for Starting a Medical Device Startup in India
Currently, India is one of the top three nations with respect to the number of startups. The medical devices sector is gaining attention owing to increased demand for high quality medical devices and large market size. High cost of imported medical devices and...
Post Market Surveillance of Medical Device in India
Medical devices are essential components of the healthcare system. Hence, strict vigilance of their efficacy and safety is necessary. All safety concerns cannot be identified during the pre-market testing phase. Post market surveillance helps identify any potential...
Basics and Tips for Medical Devices Registration in India
India is a lucrative market for medical devices business. Indian medical devices industry, one of the top 20 markets in the world, is the 4th largest market in Asia. The Indian government is aimed at establishing India as a hub for manufacturing affordable,...
Pharmaceutical Plant Design
What is a pharmaceutical plant layout? A pharmaceutical plant layout refers to the strategic floor plan of a pharmaceutical manufacturing facility, which encompasses the arrangement of spaces, machinery, and equipment to streamline the production process and ensure...
Risk Management in Medical Devices: Navigating CDSCO Regulations
Medical devices are integral to modern healthcare. From simple tools to complex machinery, they aid in diagnosis, treatment, and overall patient care. However, with this utility comes the undeniable responsibility of ensuring their safety. In India, the Central Drugs...
CDSCO Classification of Rehabilitation Medical Devices
The Central Drugs Standard Control Organisation (CDSCO) is the regulatory authority for the medical device industry in India. On 13 September 2021, CDSCO specified 60 Rehabilitation medical devices. This list includes devices such as Exothermic heat therapy packs,...
CDSCO Classification of ENT Medical Devices
The Central Drugs Standard Control Organisation (CDSCO) is the regulatory authority for the medical device industry in India. On 13 September 2021, CDSCO specified 67 ENT medical devices. This list includes devices such as Nasal septum straightening forceps, ENT...
CDSCO Sugam Portal: A Comprehensive Guide
The Central Drugs Standard Control Organization (CDSCO) is India's primary regulatory body for ensuring the safety, efficacy, and quality of drugs, cosmetics, and medical devices. To streamline its operations and make the process of applications and approvals more...
CDSCO Classification of Radiology Medical Devices
The Central Drugs Standard Control Organisation (CDSCO) is the regulatory authority for the medical device industry in India. On 13 September 2021, CDSCO specified 66 radiology medical devices. This list includes devices such as X-ray machines, MRI Machines, and...
CDSCO Classification of General Hospital / Orthopaedic Medical Devices
The Central Drugs Standard Control Organisation (CDSCO) is the regulatory authority for the medical device industry in India. On 13 September 2021, CDSCO specified 146 General Hospital/Orthopaedic medical devices. This list includes devices such as Forceps, Bone...