CDSCO Registration for Anesthesiology Medical Devices

CDSCO Registration for Anesthesiology Medical Devices. In India, the safety, quality, and efficacy of medical devices are strictly governed under the provisions of the Drugs and Cosmetics Act, 1940, and the Medical Devices Rules (MDR), 2017. One of the critical categories within medical devices includes Anesthesiology Medical Devices, also referred to as anesthesia-related devices. This branch deals with the complete perioperative management of patients, including pain medicine, intensive care, and emergency care.
From October 2022 onwards, the Government of India brought certain Anesthesiology Medical Devices under the CDSCO Licensing Regime, particularly those falling under Class A and Class B as per the risk-based classification. This article offers a detailed explanation of CDSCO Registration for Anesthesiology Medical Devices, including regulations, classification, documents, procedure, and post-registration compliances.
CDSCO Regulation on Medical Devices in India
The Central Drugs Standard Control Organisation (CDSCO) is the National Regulatory Authority of India. It is responsible for regulating Drugs, Medical Devices, and In-Vitro Diagnostic Devices. CDSCO functions under the Directorate General of Health Services, which in turn is governed by the Ministry of Health and Family Welfare, Government of India.
In January 2018, the Medical Devices Rules (MDR), 2017 came into force to strengthen the regulatory framework for medical devices. These rules introduced classification of medical devices based on the associated risk. Accordingly, the devices are categorized into four classes:

Class A: Low risk

Class B: Low to moderate risk

Class C: Moderate to high risk

Class D: High risk

The registration process and licensing requirements vary according to the risk class. For Class A and B devices, the process is comparatively simpler than for Class C and D.
Classification of Anesthesiology Medical Devices
Under the CDSCO notification, Anesthesiology Medical Devices are now classified and regulated based on their risk category and intended use. A total of 115 devices fall under this category. From October 1, 2022, only Class A and B Anesthesiology Medical Devices were brought under the CDSCO Licensing Regime.
Examples of Class A devices include Aerosol Delivery Tubing, Airway Device Cleaning Utensils, Airway protection face masks, and Anesthesia Catheter Luer Connector. These devices pose minimal risk to patients. Class B devices, like Aerosol Face Masks, Anesthesia Breathing Circuits, and Anesthesia Depth Monitors, pose slightly higher risk and thus require more regulatory scrutiny.
Manufacturers and importers of these devices are now required to obtain CDSCO Registration to sell their products in the Indian market. Without registration, their products cannot be legally marketed in India.
List of Anesthesiology Medical Devices Covered
The category includes a wide range of products like airway pressure alarms, anesthesia information systems, bronchoscopes, CPAP nasal masks, electronic esophageal stethoscopes, intubation laryngoscopes, spirometers, oxygen masks, rebreathing systems, and more. Each device has been assigned a specific class—either A or B—based on risk assessment. Devices like Ultrasonic Cough Stimulation Systems are Class A, while devices like Peak Flow Meters and Venturi Oxygen Face Masks fall under Class B. Understanding the classification of a product is the first and most important step before applying for CDSCO Registration for Anesthesiology Medical Devices.
Documents Required for CDSCO Registration for Anesthesiology Medical Devices
To ensure the quality and safety of the device, CDSCO mandates the submission of certain documents along with the registration application. These documents help the authority evaluate the credibility, safety, and conformity of the medical device.

Duly filled application form: It contains complete details about the product and applicant.

Power of Attorney: This document is needed especially for foreign manufacturers who appoint an Indian Authorized Representative.

ISO 13485 Certificate: It confirms that the manufacturer maintains a quality management system specifically for medical devices.

Certificate of Quality Assurance: This document verifies the quality practices of the manufacturing unit.

Master Plant File (MPF): This file outlines the manufacturing facility details, equipment, and procedures.

Device Master File (DMF): It includes detailed specifications, standards, testing methods, and packaging details of the product.

Free Sale Certificate (FSC): Issued by the competent authority in the country of origin, showing that the product is freely sold there.

CE Certificates: Including C.E. Quality Assurance and C.E. Design Accreditation to confirm compliance with European standards.

Declaration of Conformity: A signed document by the manufacturer declaring that the device complies with applicable regulatory requirements.

Challan TR6: Proof of fee payment submitted online for the registration process.

Procedure for CDSCO Registration for Anesthesiology Medical Devices in India
The registration process is methodical and must be followed strictly by manufacturers and importers of Anesthesiology Medical Devices.
Step 1: Determine Whether the Device is Notified
Before proceeding with the application, check whether the device falls under the notified list published by CDSCO. If the device is not notified but is new or unlisted, the applicant must apply for a No Objection Certificate (NOC) from the regulatory body.
Step 2: Appoint Authorized Representative (For Foreign Applicants)
If the manufacturer is a foreign entity, they must appoint an Authorized Indian Agent or business entity. This representative is responsible for handling correspondence with the regulatory body, application submissions, post-market surveillance, and any inspections.
Step 3: Submission of Application and Documents
The application must be submitted via the CDSCO online portal. Along with the application form, all the required documents and fee payment challan must be uploaded. Accuracy and completeness are essential to avoid unnecessary delays.
Step 4: Review and Issuance of Registration Certificate
After submission, CDSCO may raise queries or ask for clarifications. These should be addressed promptly within the given timeline. Once satisfied, the authority will issue the CDSCO Registration Certificate for the respective Anesthesiology Medical Device.
After receiving the certificate, the manufacturer or their representative can apply for an Import License if the device is being imported.
Validity of CDSCO Registration Certificate
The CDSCO Registration Certificate issued for Anesthesiology Medical Devices remains valid for three years from the date of issue. However, this is subject to compliance with applicable laws. If the certificate is suspended or cancelled due to non-compliance, the manufacturer or representative cannot continue to market the product.
Post-Compliance Requirements
Even after obtaining the registration certificate, manufacturers and importers must comply with specific obligations to maintain their license.

Notification of Changes: If there is any change in the constitution of the firm or address of the registered office or manufacturing site, CDSCO must be informed in writing immediately.

Timeline for Compliance: If such changes occur, the existing registration certificate remains valid for only three months from the date of change. Within this period, the manufacturer or their representative must apply for a new registration certificate.

Adverse Event Reporting: Any serious adverse event or malfunction related to the medical device must be reported to the CDSCO as part of the post-market surveillance system.

Renewal Before Expiry: Applications for renewal should be made before the expiry of the certificate to ensure uninterrupted business operations.

Conclusion
The CDSCO Registration for Anesthesiology Medical Devices is a mandatory regulatory requirement for both domestic and foreign manufacturers who wish to sell such devices in India. As per the Medical Devices Rules, 2017, the classification and licensing are strictly based on the risk levels of the devices. From October 2022, Class A and Class B Anesthesiology Medical Devices fall under the purview of CDSCO regulation.
Applicants must ensure they have accurate classification details, complete documentation, and proper representation if operating from outside India. Also, post-compliance responsibilities must be taken seriously to avoid penalties or suspension of the license.
By adhering to the CDSCO guidelines and following the outlined procedure, manufacturers and importers can ensure their products reach the Indian healthcare market lawfully and safely, benefitting patients and healthcare providers alike.
If you need any support in CDSCO Registration, book a consultation with Compliance Calendar LLP Experts through email at info@ccoffice.in or Call/Whatsapp at +91 9988424211.
FAQs
Q1. What is CDSCO Registration for Anesthesiology Medical Devices?
Ans. CDSCO Registration for Anesthesiology Medical Devices is a regulatory approval process mandated by the Central Drugs Standard Control Organisation. It ensures that Class A and B anesthesia-related medical devices meet safety, quality, and performance standards before being sold in the Indian market.
Q2. Which Anesthesiology Medical Devices need CDSCO Registration in India?
Ans. Only Class A (low-risk) and Class B (low to moderate-risk) anesthesiology medical devices require registration from October 1, 2022. Examples include Anesthesia Masks, CPAP Nasal Masks, Bronchoscopy Tubes, Intubation Laryngoscopes, and Venturi Oxygen Face Masks.
Q3. Who can apply for CDSCO Registration for Anesthesiology Devices?
Ans. Both Indian manufacturers and foreign manufacturers (through an Authorized Indian Representative) can apply. Foreign manufacturers must appoint a local representative who will be responsible for registration, communication, and regulatory compliance in India.
Q4. What documents are required for CDSCO Registration of Anesthesiology Medical Devices?
Ans. Applicants must submit a filled application form, Power of Attorney, ISO 13485 Certificate, Device Master File (DMF), Master Plant File (MPF), CE Certificates, Free Sale Certificate, Declaration of Conformity, and fee payment challan (TR6), among others.
Q5. What is the validity of the CDSCO Registration Certificate?
Ans. The CDSCO Registration Certificate for Anesthesiology Medical Devices is valid for 3 years from the date of issue unless cancelled or suspended by the authority due to non-compliance or regulatory violations.
Q6. What is the timeline for obtaining CDSCO Registration for Anesthesiology Medical Devices?
Ans. The timeline varies based on the completeness of the documents and the queries raised by the authority. Generally, it takes between 6 to 12 weeks after submission of a complete and compliant application.
Q7. What happens if there is a change in the manufacturing address or company structure?
Ans. The manufacturer or Authorized Representative must inform CDSCO in writing. The existing certificate will remain valid for a maximum of 3 months from the date of change, within which a fresh registration must be obtained.
Q8. Can a manufacturer sell Anesthesiology Medical Devices in India without CDSCO Registration?
Ans. No. From October 1, 2022, all Class A and B anesthesiology medical devices must be registered under CDSCO to be legally sold or distributed in India. Non-compliance may lead to product seizure and legal action.

In India, the safety, quality, and efficacy of medical devices are strictly governed under the provisions of the Drugs and Cosmetics Act, 1940, and the Medical Devices Rules (MDR), 2017. One of the critical categories within medical devices includes Anesthesiology Medical Devices, also referred to as anesthesia-related devices. This branch deals with the complete perioperative management of patients, including pain medicine, intensive care, and emergency care.

From October 2022 onwards, the Government of India brought certain Anesthesiology Medical Devices under the CDSCO Licensing Regime, particularly those falling under Class A and Class B as per the risk-based classification. This article offers a detailed explanation of CDSCO Registration for Anesthesiology Medical Devices, including regulations, classification, documents, procedure, and post-registration compliances.

CDSCO Regulation on Medical Devices in India

The Central Drugs Standard Control Organisation (CDSCO) is the National Regulatory Authority of India. It is responsible for regulating Drugs, Medical Devices, and In-Vitro Diagnostic Devices. CDSCO functions under the Directorate General of Health Services, which in turn is governed by the Ministry of Health and Family Welfare, Government of India.

In January 2018, the Medical Devices Rules (MDR), 2017 came into force to strengthen the regulatory framework for medical devices. These rules introduced classification of medical devices based on the associated risk. Accordingly, the devices are categorized into four classes:

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

The registration process and licensing requirements vary according to the risk class. For Class A and B devices, the process is comparatively simpler than for Class C and D.

Classification of Anesthesiology Medical Devices

Under the CDSCO notification, Anesthesiology Medical Devices are now classified and regulated based on their risk category and intended use. A total of 115 devices fall under this category. From October 1, 2022, only Class A and B Anesthesiology Medical Devices were brought under the CDSCO Licensing Regime.

Examples of Class A devices include Aerosol Delivery Tubing, Airway Device Cleaning Utensils, Airway protection face masks, and Anesthesia Catheter Luer Connector. These devices pose minimal risk to patients. Class B devices, like Aerosol Face Masks, Anesthesia Breathing Circuits, and Anesthesia Depth Monitors, pose slightly higher risk and thus require more regulatory scrutiny.

Manufacturers and importers of these devices are now required to obtain CDSCO Registration to sell their products in the Indian market. Without registration, their products cannot be legally marketed in India.

List of Anesthesiology Medical Devices Covered

The category includes a wide range of products like airway pressure alarms, anesthesia information systems, bronchoscopes, CPAP nasal masks, electronic esophageal stethoscopes, intubation laryngoscopes, spirometers, oxygen masks, rebreathing systems, and more. Each device has been assigned a specific class—either A or B—based on risk assessment. Devices like Ultrasonic Cough Stimulation Systems are Class A, while devices like Peak Flow Meters and Venturi Oxygen Face Masks fall under Class B. Understanding the classification of a product is the first and most important step before applying for CDSCO Registration for Anesthesiology Medical Devices.

Documents Required for CDSCO Registration for Anesthesiology Medical Devices

To ensure the quality and safety of the device, CDSCO mandates the submission of certain documents along with the registration application. These documents help the authority evaluate the credibility, safety, and conformity of the medical device.

Duly filled application form: It contains complete details about the product and applicant.
Power of Attorney: This document is needed especially for foreign manufacturers who appoint an Indian Authorized Representative.
ISO 13485 Certificate: It confirms that the manufacturer maintains a quality management system specifically for medical devices.
Certificate of Quality Assurance: This document verifies the quality practices of the manufacturing unit.
Master Plant File (MPF): This file outlines the manufacturing facility details, equipment, and procedures.
Device Master File (DMF): It includes detailed specifications, standards, testing methods, and packaging details of the product.
Free Sale Certificate (FSC): Issued by the competent authority in the country of origin, showing that the product is freely sold there.
CE Certificates: Including C.E. Quality Assurance and C.E. Design Accreditation to confirm compliance with European standards.
Declaration of Conformity: A signed document by the manufacturer declaring that the device complies with applicable regulatory requirements.
Challan TR6: Proof of fee payment submitted online for the registration process.

Procedure for CDSCO Registration for Anesthesiology Medical Devices in India

The registration process is methodical and must be followed strictly by manufacturers and importers of Anesthesiology Medical Devices.

Step 1: Determine Whether the Device is Notified

Before proceeding with the application, check whether the device falls under the notified list published by CDSCO. If the device is not notified but is new or unlisted, the applicant must apply for a No Objection Certificate (NOC) from the regulatory body.

Step 2: Appoint Authorized Representative (For Foreign Applicants)

If the manufacturer is a foreign entity, they must appoint an Authorized Indian Agent or business entity. This representative is responsible for handling correspondence with the regulatory body, application submissions, post-market surveillance, and any inspections.

Step 3: Submission of Application and Documents

The application must be submitted via the CDSCO online portal. Along with the application form, all the required documents and fee payment challan must be uploaded. Accuracy and completeness are essential to avoid unnecessary delays.

Step 4: Review and Issuance of Registration Certificate

After submission, CDSCO may raise queries or ask for clarifications. These should be addressed promptly within the given timeline. Once satisfied, the authority will issue the CDSCO Registration Certificate for the respective Anesthesiology Medical Device.

After receiving the certificate, the manufacturer or their representative can apply for an Import License if the device is being imported.

Validity of CDSCO Registration Certificate

The CDSCO Registration Certificate issued for Anesthesiology Medical Devices remains valid for three years from the date of issue. However, this is subject to compliance with applicable laws. If the certificate is suspended or cancelled due to non-compliance, the manufacturer or representative cannot continue to market the product.

Post-Compliance Requirements

Even after obtaining the registration certificate, manufacturers and importers must comply with specific obligations to maintain their license.

Notification of Changes: If there is any change in the constitution of the firm or address of the registered office or manufacturing site, CDSCO must be informed in writing immediately.
Timeline for Compliance: If such changes occur, the existing registration certificate remains valid for only three months from the date of change. Within this period, the manufacturer or their representative must apply for a new registration certificate.
Adverse Event Reporting: Any serious adverse event or malfunction related to the medical device must be reported to the CDSCO as part of the post-market surveillance system.
Renewal Before Expiry: Applications for renewal should be made before the expiry of the certificate to ensure uninterrupted business operations.

Conclusion

The CDSCO Registration for Anesthesiology Medical Devices is a mandatory regulatory requirement for both domestic and foreign manufacturers who wish to sell such devices in India. As per the Medical Devices Rules, 2017, the classification and licensing are strictly based on the risk levels of the devices. From October 2022, Class A and Class B Anesthesiology Medical Devices fall under the purview of CDSCO regulation.

Applicants must ensure they have accurate classification details, complete documentation, and proper representation if operating from outside India. Also, post-compliance responsibilities must be taken seriously to avoid penalties or suspension of the license.

By adhering to the CDSCO guidelines and following the outlined procedure, manufacturers and importers can ensure their products reach the Indian healthcare market lawfully and safely, benefitting patients and healthcare providers alike.

If you need any support in CDSCO Registration, book a consultation with Compliance Calendar LLP Experts through email at info@ccoffice.in or Call/Whatsapp at +91 9988424211.

FAQs

Q1. What is CDSCO Registration for Anesthesiology Medical Devices?

Ans. CDSCO Registration for Anesthesiology Medical Devices is a regulatory approval process mandated by the Central Drugs Standard Control Organisation. It ensures that Class A and B anesthesia-related medical devices meet safety, quality, and performance standards before being sold in the Indian market.

Q2. Which Anesthesiology Medical Devices need CDSCO Registration in India?

Ans. Only Class A (low-risk) and Class B (low to moderate-risk) anesthesiology medical devices require registration from October 1, 2022. Examples include Anesthesia Masks, CPAP Nasal Masks, Bronchoscopy Tubes, Intubation Laryngoscopes, and Venturi Oxygen Face Masks.

Q3. Who can apply for CDSCO Registration for Anesthesiology Devices?

Ans. Both Indian manufacturers and foreign manufacturers (through an Authorized Indian Representative) can apply. Foreign manufacturers must appoint a local representative who will be responsible for registration, communication, and regulatory compliance in India.

Q4. What documents are required for CDSCO Registration of Anesthesiology Medical Devices?

Ans. Applicants must submit a filled application form, Power of Attorney, ISO 13485 Certificate, Device Master File (DMF), Master Plant File (MPF), CE Certificates, Free Sale Certificate, Declaration of Conformity, and fee payment challan (TR6), among others.

Q5. What is the validity of the CDSCO Registration Certificate?

Ans. The CDSCO Registration Certificate for Anesthesiology Medical Devices is valid for 3 years from the date of issue unless cancelled or suspended by the authority due to non-compliance or regulatory violations.

Q6. What is the timeline for obtaining CDSCO Registration for Anesthesiology Medical Devices?

Ans. The timeline varies based on the completeness of the documents and the queries raised by the authority. Generally, it takes between 6 to 12 weeks after submission of a complete and compliant application.

Q7. What happens if there is a change in the manufacturing address or company structure?

Ans. The manufacturer or Authorized Representative must inform CDSCO in writing. The existing certificate will remain valid for a maximum of 3 months from the date of change, within which a fresh registration must be obtained.

Q8. Can a manufacturer sell Anesthesiology Medical Devices in India without CDSCO Registration?

Ans. No. From October 1, 2022, all Class A and B anesthesiology medical devices must be registered under CDSCO to be legally sold or distributed in India. Non-compliance may lead to product seizure and legal action.