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 from the blood. Thus, nephrology medical devices have vital lifesaving roles as well as are crucial for improving patient’s quality of life. India has an inadequacy in meeting the demand for specialized healthcare services, especially in the field of nephrology. Hence, specialised nephrology medical devices are in high demand. Thus, CDSCO has laid down stringent guidelines to regulate and monitor the quality of nephrology medical devices entering the Indian market. The goal is to prevent substandard medical devices from entering the Indian market. Therefore, maintaining regulatory compliance is a mandatory requirement for nephrology medical device companies. We have prepared this guide to help you easily secure the CDSCO nephrology medical devices license.
Demand for nephrology medical devices in India
The demand for specialized nephrology medical devices mostly remains underserved in India. Early diagnosis and treatment also occur at a low rate due to lack of screening devices. Furthermore, the implementation of secondary and tertiary prevention measures is low, as patients mostly seek medical care when they exhibit symptoms. This is when the condition has progressed to advanced stages of the illness. Thus, the nephrology segment of the Indian healthcare sector is in dire need of specialized as well as monitoring nephrology medical devices.
Diabetes and hypertension are on the rise in India. Hence, India is facing a rise in incidence of chronic kidney diseases that is propelling the growth of the Indian nephrology medical devices sector. Furthermore, ongoing innovation and advancement in the medical device sector is boosting the market growth. For example, haemodialysis machines, essential for patients with end-stage renal disease, fitted with advanced features are in high demand. These advanced machines offering precise dialysis treatment with safety mechanisms, monitoring capabilities, and improved user interfaces are fuelling the growth of the nephrology medical devices market. Moreover, an increase in awareness of the importance of early diagnosis in the treatment of kidney diseases is increasing the demand for screening and diagnostic devices. Finally, the government has launched various initiatives to facilitate early detection and screening of kidney diseases. Therefore, all these factors are driving the demand for nephrology medical devices in India.
Medical device companies can focus on nephrology medical devices to cater to the underserved demand for specialized nephrology medical devices. Additionally, they can focus on screening and diagnostic nephrology devices, which are vital for early intervention and treatment of kidney diseases. Hence, entrepreneurs venturing into the Indian nephrology medical devices sector have a bright future.
CDSCO regulations for nephrology medical devices: Mandatory compliance
Venturing into the Indian nephrology medical devices sector is a lucrative option. However, medical device companies should be mindful of the applicable CDSCO medical device regulations. As the demand for nephrology medical devices is high in India, there are chances of substandard devices entering the Indian market. These substandard devices can have a detrimental impact on patient outcome. CDSCO prioritises improved patient outcome and safety as well as effective healthcare delivery. Therefore, given the vital role of these devices and their high demand, CDSCO has formulated stringent regulations for nephrology devices in India. Securing the CDSCO nephrology medical devices license is a mandatory requirement.
CDSCO nephrology medical device classification system
The CDSCO medical device classification system has been formulated to simplify the medical device license application process. Based on the risk level associated with their intended use, the CDSCO has classified medical devices into four classes, A, B, C, and D. Specific application processes and licenses are applicable for specific CDSCO medical device classes. Hence, an understanding of the CDSCO medical device classification system is required to apply for CDSCO medical device licenses. We have provided few examples of nephrology medical devices belonging to the different CDSCO classes.
Class A
- Crimp for plier, Haemodialysis
- Chair, Haemodialysis, Electrically powered/Manual
Class B
- Urinary stone retrieval basket
- Dialyser connector
- Laser lithotripsy fibre/suction guide
- Peritoneal dialysis catheter guidewire
- Peritoneal dialysis ultraviolet irradiation unit
- Shunt thrombus suction set
- Citric acid haemodialysis system cleaning cartridge
- Extracorporeal circuit waste bag
- Haemodialysis dialysate water chlorine test kit/strip
Class C
- Automated peritoneal dialysis system
- Dialysis apheresis unit, Therapeutic
- Haemodialyzer reprocessing system
- Haemofilters
- Hemodiafiltration system
- Hollow-fibre haemodialysis dialyser
- Kidney donor-organ preservation/transport system
- Kidney stone filter
- Multi-patient dialysis fluid delivery system
- Peritoneal dialysis catheter adaptor
- Sodium carbonate haemodialysis system cleaning cartridge
- Peritoneal dialysis system dialysate filter
- Haemodialysis system plasma filtration unit
- Haemodialysis system central monitor
- Haemodialysis system bicarbonate mixer
- Haemodialysis system air/foam detector
Class D
- Absorbable peritoneum catheter cuff
- Collagen-containing peritoneum absorbable catheter cuff
To check which class your medical device belongs to, you can use our free tool.
Documents required for securing the CDSCO nephrology medical devices license
To apply for the CDSCO nephrology medical devices license, you have to prepare some supporting documents. We have listed the documents required to apply for the CDSCO medical device license.
- Organization identity proof
- Sale Deed/Rent Deed of the premises
- Building Layout with dimension
- Plant Master File
- Device Master File
- Documents for the team of qualified staff who will manufacture and test your medical devices.
- Environmental regulation compliance documents
- Certificate of analysis of 3 consecutive batches
- ISO 13485 Certificate
- Test License, if required for testing the device
We have provided an overview of the documents required. For a detailed list of documents, feel free to contact us. Furthermore, our team of experts will help you prepare and compile the documents as per CDSCO guidelines.
What are the different CDSCO nephrology medical devices license types?
- Manufacturing class A and B nephrology devices: MD 5 license will be required to manufacture class A and B nephrology devices. Moreover, a fee of Rs. 5,000 for the manufacturing license is required. Additionally, Rs. 500 for each distinct device is required. The license has to be obtained from the state licensing authority.
- Manufacturing class C and D nephrology devices: MD 9 license will be required to manufacture class C and D nephrology devices. Moreover, a fee of Rs. 50,000 for the manufacturing license is required. Additionally, Rs. 1,000 for each distinct device is required. The license has to be obtained from the central licensing authority.
- Importing nephrology devices into India: MD 15 Import License has to be secured from the CDSCO to import nephrology devices into India.
Step-by-step guide to CDSCO nephrology medical devices license application process
- Document preparation: Compile all necessary documents required for the license application. All supporting documents have to be meticulously prepared.
- Application submission: File the application online on CDSCO’s official online portal. Additionally, carefully attach all the necessary supporting documents.
- Query resolution: CDSCO may raise queries that have to be promptly and accurately addressed.
- Inspection: The regulatory officials may visit the medical device facility for inspection to ensure regulatory compliance.
- License approval: Once all the criteria are satisfied, CDSCO will grant the applicable medical device license.
Validity of the CDSCO nephrology medical devices license
The CDSCO nephrology medical devices license is valid indefinitely. However, the license retention fee has to be paid every 5 years; otherwise, the license will be cancelled automatically.
Pharmadocx Consultants: Your trusted regulatory ally for nephrology medical devices in India
Securing the CDSCO nephrology medical devices license is a mammoth task. Extensive knowledge of the CDSCO regulatory guidelines is required. Furthermore, various supporting documents have to be prepared. Thus, the CDSCO medical device license application process is arduous and time-consuming. Drop an email at [email protected] or call/Whatsapp on 9996859227 to streamline your CDSCO medical device license application process. With the help of the Pharmadocx Consultants team, your regulatory journey will be a cake walk.
