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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...
CDSCO Classification of Dental 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 91 dental medical devices. This list includes devices such as Dental excavators, Dental collar/crown...
CDSCO Classification of Cardiovascular 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 36 cardiovascular medical devices. This list includes devices such as Electrocardiographs (ECG), Cardiac...
CDSCO Classification of Medical Devices for Anesthesiology
The Central Drugs Standard Control Organisation (CDSCO) is the regulatory authority for the medical device industry in India. On 13 September 2021, CDSCO notified 112 specific medical devices for classification under Anesthesiology devices. This list includes devices...
CDSCO Classification of Medical Devices in Operation Theatre
The Central Drugs Standard Control Organisation (CDSCO) stands as the pivotal regulatory authority for the medical device industry in India. On 13 September 2021, CDSCO specified 26 specific medical devices for classification in Operation Theatres. This list includes...
Device Master Files (DMFs) in Medical Device Manufacturing
Importance of Device Master Files (DMF) in Medical Device Manufacturing The medical device industry is a rapidly evolving sector, with innovations and advancements emerging regularly. However, with innovation comes the responsibility of ensuring that these devices are...
CDSCO Registration for ENT Medical Devices in India
Otolaryngology is commonly known as the ENT (Ear, Nose, and Throat) field of medicine. It is a specialized field dedicated to diagnosing, treating, and managing conditions related to the ear, nose, and throat. When individuals encounter issues with their head or neck,...
How to get a CDSCO License for Nebulizer Manufacturing and Import
The Central Drugs Standard Control Organization (CDSCO) is the apex body in India that oversees the production and import of medical devices, including nebulizers. To either manufacture or import a nebulizer in India, a specific license, commonly referred to as the...
How To Get Medical Device Manufacturing License In India?
The medical device industry in India has witnessed exponential growth over the past few years. With advancements in technology and increasing demand for quality healthcare, the sector is poised for further expansion. However, to ensure the safety and efficacy of...
Understanding CDSCO’s Role in Medical Device Regulation in India
Introduction to CDSCO and Its Significance The Central Drugs Standard Control Organization (CDSCO) is India's premier national regulatory body for pharmaceuticals and medical devices. Governed by the Directorate General of Health Services under the Ministry of Health...
Comprehensive Guide to WHO GMP: Ensuring Global Drug Safety and Quality
The pharmaceutical industry plays a pivotal role in global health. With the increasing demand for medicines, ensuring their safety and quality becomes paramount. Enter the World Health Organization's Good Manufacturing Practices (WHO GMP) - a set of guidelines that...
Ultimate Guide to Refurbishing Outdated Pharmaceutical Plants
Breathing new life into an old pharmaceutical plant not only enhances its aesthetic appeal but also significantly boosts its value. Here's a step-by-step guide to transforming your facility into a modern, regulatory compliant, and visually appealing space. Fresh Paint...
Secure CDSCO Registration for Rehabilitation Medical Devices
Rehabilitation medical devices play a pivotal role in enhancing the quality of life of individuals with disabilities. Additionally, they are used to help those recovering from injuries. These devices have a crucial role in improving the patient’s quality of life and...
CDSCO Registration for Imaging Medical Devices: Your Guide
Imaging medical devices have revolutionized the way healthcare professionals diagnose and treat various conditions. They offer non-invasive insights into the human body. Hence, it is vital they perform as intended. Given that diagnosis depends on imaging findings,...
CDSCO License for Diabetes Management Medical Devices
Diabetes management devices are at the forefront of revolutionizing care for diabetic patients. With the rise in prevenance of diabetes in India, patients need to access high-quality devices. Hence, the Central Drugs Standard Control Organization (CDSCO), the apex...
CDSCO Ophthalmic Medical Devices Registration: Your Guide
Ophthalmic devices, pivotal in diagnosing and treating eye-related conditions, are subject to rigorous regulatory standards in India. Central Drugs Standard Control Organization (CDSCO) regulates all medical devices entering the healthcare market. Similar to all other...
CDSCO Registration for Neurological Medical Devices
Neurological devices, instrumental in diagnosing and treating conditions related to the nervous system, are under stringent regulatory oversight in India. These devices have to be strictly regulated to ensure they are safe and effective. The Central Drugs Standard...
CDSCO Registration for Orthopedic Medical Devices: Your Guide
Orthopedic and prosthetic devices are indispensable in the medical world, aiding countless individuals in mobility and improving their quality of life. These devices play a pivotal role in surgeries, rehabilitation, and enhancing mobility. The Central Drugs Standard...
CDSCO Registration for Class C & Class D Cardiovascular Medical Devices: A Comprehensive Overview
Cardiovascular devices play a pivotal role in diagnosing, treating, and managing heart-related conditions. With the Central Drugs Standard Control Organization (CDSCO) overseeing the regulatory landscape of medical devices in India, it's crucial for manufacturers and...
CDSCO License for Respiratory Medical Devices: Your Guide
CDSCO is at the forefront of ensuring that medical devices in India meet the highest standards of safety and efficacy. The Central Drugs Standard Control Organization (CDSCO), apex regulatory body for medical devices, has laid down stringent regulatory guidelines....
CDSCO Anaesthesia Medical Devices Registration in India
The Central Drugs Standard Control Organization (CDSCO) steers the medical device regulatory ship in India. Anaesthesia devices, vital for surgeries and various medical procedures, are under the spotlight for their important role in healthcare sector. In this blog, we...
CDSCO Oncology Medical Devices Registration and License
The medical device landscape in India is stringently regulated, with the Central Drugs Standard Control Organization (CDSCO) at the helm. CDSCO ensures that medical devices, especially those as critical as oncology devices, meet stringent standards to guarantee...
CDSCO Deadline for Class C & D Medical Device Licensing
The Implications for Manufacturers and Importers This shift from mandatory registration to a licensing regime is not just a change in nomenclature. It brings with it a set of responsibilities and requirements that manufacturers and importers must be prepared for: An...
Steam Sterilizer (Autoclave) CDSCO MD 9 License
A license to Manufacture or Import Steam Sterilizers or Autoclaves has been made compulsory by the CDSCO on forms MD 9 and MD 15. For Manufacturing Steam Sterilizers or Autoclaves a license on MD 9 is required and for Importing Steam Sterilizers or Autoclaves a...
ETO Sterilizer CDSCO MD 9 and MD15 License
A license to Manufacture or Import ETO Sterilizers has been made compulsory by the CDSCO. For Mnaufacutirng ETO a license on MD 9 is required and for Importing ETO Sterilizers a License on Form MD 15 is required from the CDSCO. The CDSCO with its notification date of...
Intravenous Set: The Complete Guide to Its Use in Medical Devices
As a medical professional or patient, you may have come across an intravenous (IV) set at some point. IV sets are a critical component in medical devices, providing a safe and effective way to deliver fluids, medications, and nutrients directly into the bloodstream....
License to Manufacture Thermometer
Complete information regarding various licenses and approvals which are required in order to Manufacture and import different types of Thermometers.
Latex and Nitrile Gloves CDSCO Medical Device License (MD5 MD15)
In order to manufacture and import gloves, you need to get a license from CDSCO. Here you will find answers to various questions on latex and nitrile gloves license requirements. We will answer the following questions - What are the various types of gloves as per...