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 launching pediatrics and neonatology medical devices in India. In this blog, we have discussed how to secure the CDSCO pediatrics and neonatology medical devices license. Additionally, we have mentioned the necessary documents required.
Indian pediatrics and neonatology medical devices market: An overview
The Indian pediatrics and neonatology medical devices market is expected to grow at a CAGR of 5.9% during the period 2025 to 2030. The market is expected to grow significantly and has a bright future. The key factors driving the growth of this market is: rise in preterm birth rates, increase in public awareness of the importance of prenatal and neonatal care, and technological advancements. Additionally, government initiatives to improve infant care and infrastructural development are also vital factors.
Market trend
- The incubator segment of the market has considerable potential for growth
- Prenatal monitoring devices are in high-demand
- Pediatric medical implants are in great demand
- IVDs used to diagnose various diseases in children are also in demand
- Respiratory assistance and monitoring devices segment is expected to grow significantly
Thus, the Indian pediatrics and neonatology medical devices market is projected to grow considerably. Various factors are propelling the growth of this sector of the medical device industry. Hence, this seems the right time for medical device companies to venture into the pediatrics and neonatology medical devices market.
How to secure the CDSCO pediatrics and neonatology medical devices license?
Are you planning to venture into the pediatrics and neonatology medical devices market? You need to secure the CDSCO medical device license to legally market your product in India. To apply for the CDSCO pediatrics and neonatology medical devices license, first you need to understand the CDSCO medical device classification system. The CDSCO class of your medical device will determine the course of the license application process. Hence, we have provided a brief overview.
Pediatrics and neonatology medical device classification system
The CDSCO has classified medical devices into four classes. This system is based on the risk level associated with the intended use of the device. The classes in increasing order of risk level are A, B, C, and D. This device classification system has been formulated to simplify the medical device license application process. Moreover, specific application processes and licenses are applicable for specific CDSCO medical device classes. Hence, the first step in the license application process is to check which class your device belongs to, as it will determine the next course of action.
CDSCO pediatrics and neonatology medical device classes
We have listed few examples of pediatrics and neonatology devices belonging to the different CDSCO classes.
Class A
- Assistive ergonomic chair mobility base
- Exhaled-gas oesophageal intubation detector, paediatric
- Infant care table
- Infant incubator warming hood
- Infant inguinal hernia truss
- Infant limb immobilizer, reusable
- Infant limb immobilizer, single-use
- Infant sleep positioner
- Infant-hammock bed mattress overlay
- Microlaryngeal probe
- Phototherapy eye protector, singleuse
- Birthing bath
- Newborn-infant bed
- Nasal aspirator, electric
Class B
- Anaesthesia Facemask, single use (paediatric)
- Anaesthesia Facemask, reusable (paediatric)
- Circulating-fluid whole-body heating/cooling system pad, reusable
- External counterpulsation system, paediatric
- External defibrillator electrode, paediatric, reusable
- External defibrillator electrode, paediatric, single-use
- Hepatic ultrasound elastography system applicator
- Infant bed crib top
- Infant bed restraint
- Neonatal chest percussor
- Neonatal hypothermia cot
- Flotation therapy bed, neonatal
Class C
- Antimicrobial endotracheal tube, paediatric
- Breathing circuit gas-flow sensor, reusable
- Breathing circuit gas-flow sensor, single-use
- Cuff-suction endotracheal tube
- Flexible bone nail, non-sterile
- Funnel chest remodelling bar
- Infant apnoea monitor
- Infant incubator control unit
- Infant/regional-body warmer
- Internal defibrillator electrode, paediatric
- Neonatal intensive-care ventilator
- Neonatal physiologic monitoring system
- Mobile steam washer/disinfector
- Syringe pump
- Respiratory apnoea monitoring system
- Skin transilluminator, batterypowered
Class D
- Craniofacial bone screw, bioabsorbable
- Polyglyconate suture
To check which class your medical device belongs to, you can use our free tool.
List of documents required for the CDSCO pediatrics and neonatology medical devices license application
Various supporting documents have to be prepared and submitted along with the CDSCO license application. We have listed the documents required to apply for the CDSCO pediatrics and neonatology medical devices license.
- Sale Deed/Rent Deed of the Premises
- Organization identity proof
- Building Layout with dimension
- Documents for the team of qualified and experienced staff who can manufacture and test your medical devices.
- Device Master File
- Plant Master File
- Test License, if required for testing the medical device
- Environmental regulation compliance documents
- Certificate of analysis of 3 consecutive batches
- ISO 13485 Certificate
In the above list, we have provided an overview of the documents required. For a detailed list of documents, feel free to contact us. Moreover, we have extensive expertise in CDSCO document preparation requirements. Avail our comprehensive document preparation service to have a smooth CDSCO license application process.
CDSCO pediatrics and neonatology medical devices license types and requirements
- Importing pediatrics and neonatology medical devices into India: MD 15 import license has to be secured from the CDSCO to import pediatrics and neonatology medical equipment into India.
- Manufacturing class A and B pediatrics and neonatology devices: MD 5 license will be required to manufacture class A and B pediatrics and neonatology devices in India. Moreover, a fee of Rs. 5,000 for the manufacturing license is required. Furthermore, Rs. 500 for each distinct device is required. The license has to be obtained from the state licensing authority.
- Manufacturing class C and D pediatrics and neonatology devices: MD 9 license will be required to manufacture class C and D pediatrics and neonatology devices in India. Moreover, a fee of Rs. 50,000 for the manufacturing license is required. Furthermore, Rs. 1,000 for each distinct device is required. The license has to be obtained from the central licensing authority.
CDSCO pediatrics and neonatology medical devices license validity
The CDSCO pediatrics and neonatology medical devices license is valid indefinitely. However, the license retention fee has to be paid every 5 years to maintain the license validity.
CDSCO pediatrics and neonatology medical devices license application process: A step-by-step guide
The CDSCO license application process for pediatrics and neonatology medical devices involves the following steps:
- Applicant registration: Register/login to the SUGAM portal.
- Document preparation: Compile all necessary supporting documents for license application.
- Online application: File the application online on CDSCO’s official online portal. Additionally, upload all the necessary documents.
- Query resolution: Promptly and accurately respond to all the queries raised by CDSCO.
- Inspection: The regulatory officials may visit the medical device facility to carryout inspection and audit.
- License grant: The regulatory officials will review the application and verify the documents. Once all the criteria are satisfied, CDSCO will grant the applicable medical device license.
Pharmadocx Consultants team will help you easily secure the CDSCO license for pediatrics and neonatology medical devices
Are you planning to venture into the pediatrics and neonatology medical devices sector? You need to comply with all the CDSCO regulations to secure the CDSCO pediatrics and neonatology medical devices license. Navigating the CDSCO regulatory guidelines can be a tricky task from identifying the applicable license to preparing the supporting documents. Fret not! We at Pharmadocx Consultants will be more than happy to help. Our comprehensive services are aimed to simplify the regulatory journey for medical device manufacturers and importers. Compliance with CDSCO regulatory guidelines is a testament of the manufacturer’s dedication to patient safety and product quality. Furthermore, mandatory CDSCO medical device license requirement ensures the healthcare professionals are equipped with the best tools for patient care. Additionally, staying regulatory compliant improves brand reputation and helps avoid potential negative regulatory repercussions. Email at [email protected] or call/Whatsapp on 9996859227 and we will help you easily secure the CDSCO license.
