CDSCO Registration for Paediatrics and Neonatology Medical Device

CDSCO Registration for Paediatrics and Neonatology Medical Device. The CDSCO Registration for Paediatrics and Neonatology Medical Device is a mandatory regulatory process governed by the Central Drugs Standard Control Organization (CDSCO). This authority operates under the Ministry of Health and Family Welfare and is led by the Drugs Controller General of India (DCGI). The registration ensures that medical devices meant for paediatric and neonatal use are safe, effective, and meet the quality standards required before being marketed in India. A detailed notification was issued by the DCGI on 23rd August 2021, listing 136 specific medical devices under this category.
Overview of Medical Device Rules, 2017
The Medical Device Rules, 2017 were introduced to regulate the manufacturing, import, clinical investigation, distribution, and sale of medical devices in India. These rules came into effect on 1st January 2018. Their primary goal is to distinguish medical devices from pharmaceutical drugs and create a dedicated framework for regulating devices. These rules apply to all medical devices and ensure their safety and performance through a well-structured classification system.
Medical devices under these rules include instruments or substances used either internally or externally for diagnosis, prevention, or treatment of diseases in humans or animals. They can also include substances that modify or affect the body’s functions or structure and items used in in-vitro diagnostics. Surgical items such as dressings, staples, ligatures, sutures, and blood-related products (even those with anticoagulants) also fall under this definition.
Classification of Medical Devices Based on Risk
To streamline the regulatory process, medical devices are classified into four classes based on the level of risk they pose:

Class A: Low-risk devices

Class B: Low to moderate risk

Class C: Moderate to high risk

Class D: High-risk devices

This classification of medical devices helps authorities evaluate the necessary safety and performance protocols depending on how important the medical device is. Devices in higher risk categories (C and D) require more detailed technical documentation and compliance checks compared to Class A and B.
Types of Medical Devices in India
In India, medical devices are grouped into two categories:

Notified Medical Devices: These are devices that have been specifically notified by the government and are already under the regulatory scope of CDSCO.

Non-Notified Medical Devices: These devices were not previously regulated but have since been brought under regulation. The government had allowed voluntary registration for such devices for a limited time.

The deadline for voluntary registration of Class A and B devices was 1st October 2022, while for Class C and D, it was 1st October 2023. After these dates, registration became mandatory for even the previously non-notified devices. Initially, only 37 devices were notified, but with the expansion of the medical device industry in India, many more have been added to ensure safety and consumer protection.
CDSCO Notification for Paediatrics and Neonatology Medical Devices
On 3rd September 2020, the Ministry of Health and Family Welfare issued a notification expanding the list of non-notified medical devices requiring CDSCO registration. This list included 24 new categories such as Anaesthesiology, Cardiovascular, ENT, Dental, and also Paediatrics and Neonatology.
Following this, a detailed classification for Paediatrics and Neonatology medical devices was issued on 23rd August 2021. A total of 136 medical devices specific to the care of infants and children were identified and placed under different risk classes ranging from A to D. Each of these devices is now subject to CDSCO Registration for Paediatrics and Neonatology Medical Device.
Classification of Paediatrics and Neonatology Medical Devices
The 136 medical devices under this category include a wide range of equipment used in neonatal and paediatric care. These devices are classified based on intended use and risk level. For example:

Class A Devices include items like infant care tables, limb immobilizers, and baby beds that pose minimal risk. These are simple, low-risk items used in day-to-day care.

Class B Devices involve moderate complexity like neonatal CPAP units, incubator control units, and warming beds. These require more stringent quality checks.

Class C Devices include sophisticated monitoring systems, ventilators, and devices like antimicrobial endotracheal tubes. These pose moderate to high risk and thus require more detailed documentation and compliance procedures.

Class D Devices are the highest-risk category and include items like bio-absorbable bone screws and complex surgical implants.

The classification helps streamline the registration process by ensuring that safety standards are matched with the device’s complexity.
List of Sample Medical Devices
To provide clarity, here are a few examples of the devices included in each class:

Class A: Infant scale, nasal aspirator, nappy changing table, open-ended urine collection bags

Class B: Anaesthesia face masks, paediatric beds, resuscitator face masks

Class C: Neonatal intensive care ventilators, internal defibrillator electrodes, heart rate monitoring software

Class D: Bio-absorbable bone screws, polyglyconate sutures

Each listed device has been assigned a risk class that determines the level of scrutiny it must undergo before getting a CDSCO Registration for Paediatrics and Neonatology Medical Device.
Documents Required for CDSCO Registration for Paediatrics and Neonatology Medical Device
To obtain the registration, manufacturers or importers must submit a detailed list of documents. These documents help prove the device’s safety, efficacy, and conformity to quality standards. The documents required include:

Application Form: The standard form used to apply for the registration.

TR6 Challan: A payment receipt showing the government fee payment.

Power of Attorney: Required when the application is filed through an Indian Authorized Agent.

Certificate of Quality Assurance: Shows the product meets recognized quality standards.

CE Certificate: Certificate of European Conformity (if available).

ISO 13485 Certification: This is an international standard for quality management systems for medical devices.

Declaration of Conformity: A self-declaration stating that the device complies with all applicable regulations.

Schedule D(I): Information related to manufacturing sites outside India.

Plant Master File: Contains all technical data and operational details of the manufacturing site.

Device Master File: Describes the product, its composition, design, packaging, and sterilization methods.

Free Sale Certificate: Issued by regulatory authorities in the country of origin.

Undertaking: A statement declaring that all submitted information is true and correct.

Procedure for CDSCO Medical Device Registration for Paediatrics and Neonatology
The process for CDSCO Registration for Paediatrics and Neonatology Medical Device involves several key steps. It is important to follow these steps carefully to avoid delays or rejections.

Check Notification List: The first step is to check whether the medical device is listed in the notified or non-notified category. If the device is non-notified but falls under the CDSCO extended list, then voluntary registration must have been completed before the deadline.

Appoint Indian Authorized Agent (IAA): If the manufacturer is based outside India, an Indian Authorized Agent must be appointed to represent the company in all regulatory matters.

Prepare Documentation: All the required documents, including quality certificates, conformity declarations, and technical files, must be compiled.

Online Submission: The registration application is submitted via the CDSCO SUGAM portal. The form must be filled accurately with all supporting documents uploaded.

Payment of Fees: The government registration fees are paid via TR6 Challan and submitted along with the application.

Review by CDSCO: CDSCO reviews the application and supporting documents. They may ask for additional clarification if needed.

Issuance of Registration: Once the application is approved and all requirements are met, the CDSCO grants the registration license, allowing the product to be legally imported or manufactured in India.

Conclusion
The CDSCO Registration for Paediatrics and Neonatology Medical Device is now an important requirement to ensure that devices meant for infant and child healthcare in India are safe and effective. The notification issued on 23rd August 2021 specifically lists 136 such devices under various risk classes. These devices must be registered under the Medical Device Rules, 2017 before they are marketed or used in the country.
The registration process involves documentation, quality certification, risk classification, and in some cases, the appointment of an Indian Authorized Agent. Due to the technical nature of the process, it is always advisable to consult with Compliance Calendar LLP professionals who can assist with accurate application submission and avoid delays or rejections. This not only ensures legal compliance but also protects the health and well-being of paediatric and neonatal patients in India.
Email: info@ccoffice.in
Call/Whatsapp at: +91 9988424211.
FAQs
Q1. What is CDSCO Registration for Paediatrics and Neonatology Medical Device? 
Ans. CDSCO Registration for Paediatrics and Neonatology Medical Device is a regulatory process that ensures medical devices intended for use in infants and children are safe, effective, and meet the required Indian standards. It is governed by the CDSCO under the Ministry of Health and Family Welfare.
Q2. Why is this registration mandatory? 
Ans. This registration is mandatory to ensure that paediatric and neonatology medical devices are tested, validated, and meet Indian safety and quality norms before being manufactured, imported, or sold in the country. It helps in avoiding health risks associated with unregulated devices.
Q3. How many medical devices are listed under Paediatrics and Neonatology? 
Ans. A total of 136 medical devices have been classified under Paediatrics and Neonatology as per the CDSCO notification dated 23rd August 2021. These are categorized based on their intended use and associated risk.
Q4. What are the risk classes for these medical devices? 
Ans. The devices are classified into four classes: Class A (low-risk), Class B (low to moderate risk), Class C (moderate to high risk), and Class D (high-risk). The classification helps determine the level of scrutiny and documentation required.
Q5. Who needs to apply for the registration? 
Ans. Manufacturers or importers of paediatrics and neonatology medical devices must apply. If the manufacturer is not based in India, an Indian Authorized Agent (IAA) must be appointed to handle the registration and legal representation in India.
Q6. What documents are required for the application? 
Ans. Essential documents include the application form, TR6 challan, power of attorney, ISO 13485 certificate, CE accreditation (if applicable), Plant and Device Master Files, Free Sale Certificate, and a declaration of conformity. All these ensure compliance with CDSCO norms.
Q7. What happens if a device is sold without registration? 
Ans. Selling or importing a medical device without CDSCO registration is a violation of the Medical Device Rules, 2017, and can lead to penalties, cancellation of license, or legal action. It is mandatory for all manufacturers and importers to obtain proper registration before entering the Indian market.

The CDSCO Registration for Paediatrics and Neonatology Medical Device is a mandatory regulatory process governed by the Central Drugs Standard Control Organization (CDSCO). This authority operates under the Ministry of Health and Family Welfare and is led by the Drugs Controller General of India (DCGI). The registration ensures that medical devices meant for paediatric and neonatal use are safe, effective, and meet the quality standards required before being marketed in India. A detailed notification was issued by the DCGI on 23rd August 2021, listing 136 specific medical devices under this category.

Overview of Medical Device Rules, 2017

The Medical Device Rules, 2017 were introduced to regulate the manufacturing, import, clinical investigation, distribution, and sale of medical devices in India. These rules came into effect on 1st January 2018. Their primary goal is to distinguish medical devices from pharmaceutical drugs and create a dedicated framework for regulating devices. These rules apply to all medical devices and ensure their safety and performance through a well-structured classification system.

Medical devices under these rules include instruments or substances used either internally or externally for diagnosis, prevention, or treatment of diseases in humans or animals. They can also include substances that modify or affect the body’s functions or structure and items used in in-vitro diagnostics. Surgical items such as dressings, staples, ligatures, sutures, and blood-related products (even those with anticoagulants) also fall under this definition.

Classification of Medical Devices Based on Risk

To streamline the regulatory process, medical devices are classified into four classes based on the level of risk they pose:

Class A: Low-risk devices
Class B: Low to moderate risk
Class C: Moderate to high risk
Class D: High-risk devices

Types of Medical Devices in India

In India, medical devices are grouped into two categories:

Notified Medical Devices: These are devices that have been specifically notified by the government and are already under the regulatory scope of CDSCO.
Non-Notified Medical Devices: These devices were not previously regulated but have since been brought under regulation. The government had allowed voluntary registration for such devices for a limited time.

CDSCO Notification for Paediatrics and Neonatology Medical Devices

On 3rd September 2020, the Ministry of Health and Family Welfare issued a notification expanding the list of non-notified medical devices requiring CDSCO registration. This list included 24 new categories such as Anaesthesiology, Cardiovascular, ENT, Dental, and also Paediatrics and Neonatology.

Following this, a detailed classification for Paediatrics and Neonatology medical devices was issued on 23rd August 2021. A total of 136 medical devices specific to the care of infants and children were identified and placed under different risk classes ranging from A to D. Each of these devices is now subject to CDSCO Registration for Paediatrics and Neonatology Medical Device.

Classification of Paediatrics and Neonatology Medical Devices

The 136 medical devices under this category include a wide range of equipment used in neonatal and paediatric care. These devices are classified based on intended use and risk level. For example:

Class A Devices include items like infant care tables, limb immobilizers, and baby beds that pose minimal risk. These are simple, low-risk items used in day-to-day care.
Class B Devices involve moderate complexity like neonatal CPAP units, incubator control units, and warming beds. These require more stringent quality checks.
Class C Devices include sophisticated monitoring systems, ventilators, and devices like antimicrobial endotracheal tubes. These pose moderate to high risk and thus require more detailed documentation and compliance procedures.
Class D Devices are the highest-risk category and include items like bio-absorbable bone screws and complex surgical implants.

The classification helps streamline the registration process by ensuring that safety standards are matched with the device’s complexity.

List of Sample Medical Devices

To provide clarity, here are a few examples of the devices included in each class:

Class A: Infant scale, nasal aspirator, nappy changing table, open-ended urine collection bags
Class B: Anaesthesia face masks, paediatric beds, resuscitator face masks
Class C: Neonatal intensive care ventilators, internal defibrillator electrodes, heart rate monitoring software
Class D: Bio-absorbable bone screws, polyglyconate sutures

Each listed device has been assigned a risk class that determines the level of scrutiny it must undergo before getting a CDSCO Registration for Paediatrics and Neonatology Medical Device.

Documents Required for CDSCO Registration for Paediatrics and Neonatology Medical Device

To obtain the registration, manufacturers or importers must submit a detailed list of documents. These documents help prove the device’s safety, efficacy, and conformity to quality standards. The documents required include:

Application Form: The standard form used to apply for the registration.
TR6 Challan: A payment receipt showing the government fee payment.
Power of Attorney: Required when the application is filed through an Indian Authorized Agent.
Certificate of Quality Assurance: Shows the product meets recognized quality standards.
CE Certificate: Certificate of European Conformity (if available).
ISO 13485 Certification: This is an international standard for quality management systems for medical devices.
Declaration of Conformity: A self-declaration stating that the device complies with all applicable regulations.
Schedule D(I): Information related to manufacturing sites outside India.
Plant Master File: Contains all technical data and operational details of the manufacturing site.
Device Master File: Describes the product, its composition, design, packaging, and sterilization methods.
Free Sale Certificate: Issued by regulatory authorities in the country of origin.
Undertaking: A statement declaring that all submitted information is true and correct.

Procedure for CDSCO Medical Device Registration for Paediatrics and Neonatology

The process for CDSCO Registration for Paediatrics and Neonatology Medical Device involves several key steps. It is important to follow these steps carefully to avoid delays or rejections.

Check Notification List: The first step is to check whether the medical device is listed in the notified or non-notified category. If the device is non-notified but falls under the CDSCO extended list, then voluntary registration must have been completed before the deadline.
Appoint Indian Authorized Agent (IAA): If the manufacturer is based outside India, an Indian Authorized Agent must be appointed to represent the company in all regulatory matters.
Prepare Documentation: All the required documents, including quality certificates, conformity declarations, and technical files, must be compiled.
Online Submission: The registration application is submitted via the CDSCO SUGAM portal. The form must be filled accurately with all supporting documents uploaded.
Payment of Fees: The government registration fees are paid via TR6 Challan and submitted along with the application.
Review by CDSCO: CDSCO reviews the application and supporting documents. They may ask for additional clarification if needed.
Issuance of Registration: Once the application is approved and all requirements are met, the CDSCO grants the registration license, allowing the product to be legally imported or manufactured in India.

Conclusion

The CDSCO Registration for Paediatrics and Neonatology Medical Device is now an important requirement to ensure that devices meant for infant and child healthcare in India are safe and effective. The notification issued on 23rd August 2021 specifically lists 136 such devices under various risk classes. These devices must be registered under the Medical Device Rules, 2017 before they are marketed or used in the country.

The registration process involves documentation, quality certification, risk classification, and in some cases, the appointment of an Indian Authorized Agent. Due to the technical nature of the process, it is always advisable to consult with Compliance Calendar LLP professionals who can assist with accurate application submission and avoid delays or rejections. This not only ensures legal compliance but also protects the health and well-being of paediatric and neonatal patients in India.

Email: info@ccoffice.in

Call/Whatsapp at: +91 9988424211.

FAQs

Q1. What is CDSCO Registration for Paediatrics and Neonatology Medical Device?

Ans. CDSCO Registration for Paediatrics and Neonatology Medical Device is a regulatory process that ensures medical devices intended for use in infants and children are safe, effective, and meet the required Indian standards. It is governed by the CDSCO under the Ministry of Health and Family Welfare.

Q2. Why is this registration mandatory?

Ans. This registration is mandatory to ensure that paediatric and neonatology medical devices are tested, validated, and meet Indian safety and quality norms before being manufactured, imported, or sold in the country. It helps in avoiding health risks associated with unregulated devices.

Q3. How many medical devices are listed under Paediatrics and Neonatology?

Ans. A total of 136 medical devices have been classified under Paediatrics and Neonatology as per the CDSCO notification dated 23rd August 2021. These are categorized based on their intended use and associated risk.

Q4. What are the risk classes for these medical devices?

Ans. The devices are classified into four classes: Class A (low-risk), Class B (low to moderate risk), Class C (moderate to high risk), and Class D (high-risk). The classification helps determine the level of scrutiny and documentation required.

Q5. Who needs to apply for the registration?

Ans. Manufacturers or importers of paediatrics and neonatology medical devices must apply. If the manufacturer is not based in India, an Indian Authorized Agent (IAA) must be appointed to handle the registration and legal representation in India.

Q6. What documents are required for the application?

Ans. Essential documents include the application form, TR6 challan, power of attorney, ISO 13485 certificate, CE accreditation (if applicable), Plant and Device Master Files, Free Sale Certificate, and a declaration of conformity. All these ensure compliance with CDSCO norms.

Q7. What happens if a device is sold without registration?

Ans. Selling or importing a medical device without CDSCO registration is a violation of the Medical Device Rules, 2017, and can lead to penalties, cancellation of license, or legal action. It is mandatory for all manufacturers and importers to obtain proper registration before entering the Indian market.