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What Are Good Distribution Practices for Pharmaceuticals?
Given the vital role of drugs in healthcare system, their quality and efficacy have to be regulated at every stage. Stringent guidelines are in place right from raw material procurement to the transportation of the finished product to the patients. Good distribution...
Selecting Pharmaceutical Manufacturing Equipment & Machinery
Setting up a pharmaceutical manufacturing company is a daunting task. To establish a pharma company, you need to set up a manufacturing facility equipped with various machineries and equipment. It is important to choose the appropriate pharmaceutical manufacturing...
How To Start a Pharmaceutical Manufacturing Company in India?
In this blog, we have curated a detailed guide for starting a pharmaceutical manufacturing company in India. Rise and rise of the Indian pharmaceutical industry Why should you consider starting a pharmaceutical manufacturing company in India? To answer this question,...
CDSCO Market Standing Certificate: Everything You Need to Know
Companies secure a market standing certificate to demonstrate the potential of their business. The CDSCO issues the market standing certificate for pharmaceutical and medical device companies. Read on to find out more about the CDSCO market standing certificate, its...
A Comprehensive Guide for Manufacturing Blood Bags
Blood bags are lifesaving critical medical devices. In this blog, we have detailed the process of manufacturing blood bags. We have also provided an overview of the Indian blood bag market. This will help you determine whether you should start a blood bag business in...
Manufacturing Stents in India: Types, Demand, And Regulations
Stents form the backbone of various minimally invasive surgeries, such as angioplasty. Read on to find out about the demand for stents in India. We have also provided an overview of the steps involved in manufacturing stents. What are stents? Stents are small...
How to Select the Appropriate Medical Device Manufacturing Site?
The current Indian market is conducive for setting up a medical device manufacturing business. Selecting the correct location for setting up your medical device manufacturing facility is vital for the success of your business. This blog provides some tips for...
3 Way Stop Cock Manufacturing Business : A Guide
3-way stopcocks have a paramount role in the healthcare industry. Their pivotal role in the healthcare industry ranges from controlling the flow of fluids to facilitating efficient patient care. It is important to understand the role of this device before starting a 3...
Surgical Sutures: Manufacturing, Regulations & Demand in India
Surgical sutures are essential for performing most surgeries. These medical devices are designed to facilitate the healing process. Most surgical or traumatic wound closure would require sutures. The increase in number of surgeries performed in India is boosting the...
Surgical Drapes: Details, Manufacturing & Regulations
Patients are highly susceptible to infections and infection related complications during surgery. This can have detrimental consequences. Surgical site infection or SSI has to be prevented for improved patient outcome and a successful surgery. Surgical drapes are a...
Pulse Oximeter Manufacturing Process: A Vital Medical Device
Pulse oximeters are used to monitor patients’ oxygen levels and pulse rates. They are of use to both patients and healthcare professionals. In this blog, we will highlight the vital role of pulse oximeters in the healthcare industry. Additionally, this blog will...
Disposable Syringe Manufacturing: Requirements and Regulations
Previously, glass was used for manufacturing reusable syringes. However, the healthcare industry has switched to single-use sterile plastic disposable syringes. Disposable syringes are currently in very high demand in India. Medical device manufacturing companies can...
7 Commonly Used Medical Device Sterilization Methods: A Guide
While using medical devices to diagnose, monitor, and treat patients, they come in direct contact with patients. They may be used externally or internally. Thus, proper sterilization of medical devices is necessary to reduce chances of infection caused by these...
Technology Transfer in Medical Devices: The What and Why
The Indian medical devices industry is dynamic and evolving. India is witnessing an increasing demand for technologically advanced novel medical devices. Technology transfer increases local production, thereby increasing access to advanced medical devices. Medical...
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...