CDSCO Registration for Interventional and Radiology Medical Devices

CDSCO Registration for Interventional and Radiology Medical Devices. Interventional radiology plays an important role in diagnosing and treating a wide range of diseases. This branch of medicine utilizes minimally invasive techniques, which involve the insertion of small instruments such as catheters and wires, often guided by advanced imaging machines like CT scans, X-rays, and ultrasound. These procedures provide an alternative to open surgery, minimizing risks and reducing the patient’s hospital stay. Given the importance of such medical devices, the Central Drugs Standard Control Organisation (CDSCO) mandates a strict registration process for interventional and radiology medical devices to ensure their safety and effectiveness in India.
Risk-Based Classification of Medical Devices
On 3rd September 2020, the CDSCO issued a draft for the classification of non-notified medical devices. This move was initiated by the Ministry of Health and Family Welfare to bring all medical devices under regulation. For instance, items such as gowns, adhesive drapes, and coveralls are classified as Class A (low-risk), while surgical drapes and non-notified in-vitro diagnostics (IVDs) fall under Class B (low-moderate risk).
In February 2020, the Ministry made a significant regulatory change by releasing a formal definition of medical devices and including Chapter IIIA in the Medical Device Rules, 2017. This chapter made it compulsory for all manufacturers and importers of non-notified medical devices to register their products with CDSCO, effective from 1st April 2020.
Under Chapter II, Rule 3 of the Medical Device Rules, 2017, medical devices in India are classified based on the level of risk they pose to patients:

Class A: Low risk

Class B: Low-moderate risk

Class C: Moderate-high risk

Class D: High risk

Each class determines the regulatory pathway, documentation, and approvals required for CDSCO Registration for Interventional and Radiology Medical Devices.
Categorization of Medical Devices
CDSCO has notified a wide range of medical device categories, and interventional and radiology devices are among them. The notification mandates that these categories of devices must be registered under the CDSCO regime. Some of the other categories include devices used in anesthesiology, pain management, cardiovascular treatments, dental care, ENT, gastroenterology, urology, general hospital use, operating theaters, and respiratory treatments.
Other categories also cover neurological, gynecological, ophthalmic, rehabilitation, dermatology, oncology, radiotherapy, nephrology, and software-driven devices. All these categories fall under the regulatory purview of CDSCO for registration and compliance.
Classification of Devices regarding Interventional and Radiology
The CDSCO has defined risk classes for individual interventional and radiology devices. These classifications determine the level of scrutiny and documentation required for CDSCO Registration for Interventional and Radiology Medical Devices. For example:

Devices such as Scintillation (gamma) cameras, positron cameras, and nuclear scanners are categorized under Class A, indicating low risk.

Diagnostic X-Ray systems, mammographic X-ray systems, and MRI systems are generally placed under Class C, indicating moderate to high risk.

Devices like ultrasonic Doppler imaging systems and diagnostic ultrasonic transducers are classified under Class B, showing moderate risk.

This classification ensures that the devices are thoroughly evaluated based on their potential impact on human health before they reach the market.
Documents Required for CDSCO Registration for Interventional and Radiology Medical Devices
For a successful registration with CDSCO, the manufacturer or importer must provide several essential documents. Each of these documents is critical for assessing the quality, safety, and compliance of the medical device:

A duly filled application form is required to initiate the registration process. This form includes vital details about the applicant, the device, and its specifications.

ISO 13485 Certificate demonstrates that the manufacturer follows international quality standards for medical device manufacturing.

Full Quality Assurance Certificate confirms the reliability of the manufacturing process and end-product quality.

CE Design Certificate is necessary if the device is manufactured in Europe and meets European safety and design standards.

An undertaking from the applicant confirming the authenticity of all information submitted is mandatory.

A Free Sale Certificate (FSC) or a certificate from the foreign government verifies that the device is freely sold in the country of origin.

The Plant Master Report provides an overview of the manufacturing site, processes, and facilities.

The Device Master File includes detailed technical specifications and information about the medical device.

A Declaration of Conformity affirms that the device complies with applicable regulatory requirements.

Procedure for CDSCO Registration for Interventional and Radiology Medical Devices
The CDSCO Registration for Interventional and Radiology Medical Devices follows a structured and step-wise process. Each step involves specific actions and documentation to ensure complete transparency and compliance.
Step 1: Identify Whether the Device is Notified Before applying for registration, the manufacturer or importer must first determine if the medical device is part of the notified list released by CDSCO. If it is a notified device, registration is mandatory. For non-notified or new devices, the applicant may be required to obtain a No Objection Certificate (NOC) before proceeding further.
Step 2: Appoint an Authorized Representative (For Foreign Manufacturers) Foreign manufacturers must appoint an Authorized Representative in India. This representative acts as the local point of contact for all regulatory communications. They are responsible for addressing queries from CDSCO, coordinating inspections, and ensuring that the product complies with Indian laws.
Step 3: Filing the Application Once the necessary documents are ready, the applicant must file the registration application through the CDSCO online portal. This includes uploading the regulatory dossier and paying the applicable registration fee. The application is then submitted to the Directorate General of Health Services (DGHS) for review.
Step 4: Registration Review and Approval CDSCO may raise queries during the review process. These could be requests for clarification or additional documentation. In some cases, the authority may even ask for a technical presentation or demonstration. If the CDSCO is satisfied with the provided details, it will issue a CDSCO Registration Certificate.
Note: The validity of the CDSCO Registration for Interventional and Radiology Medical Devices is three years from the date of issuance unless suspended or cancelled earlier by the authority.
Post-Compliance After Getting CDSCO Registration
Once the CDSCO Registration Certificate is granted, the manufacturer or importer must ensure continuous compliance with regulatory requirements.
If there is any change in the constitution of the company or the address of its registered office or manufacturing unit, the Licensing Authority must be informed in writing. This ensures that the CDSCO database is always updated with the correct information.
Moreover, when such changes occur, the existing registration certificate remains valid for only three months. Within this time, the applicant must apply for a new CDSCO Registration Certificate. Failure to do so can result in penalties or suspension of existing registration.
Conclusion
The medical device industry of India is growing with increasing reliance on technology-driven diagnostic and treatment solutions. Interventional and radiology medical devices form a crucial part of this ecosystem. Given their direct application to human health, it becomes essential for manufacturers and importers to follow the proper legal framework for bringing these devices into the Indian market.
CDSCO Registration for Interventional and Radiology Medical Devices not only ensures compliance with Indian laws but also guarantees that the devices used are safe, effective, and of high quality. By following the step-by-step registration process, maintaining up-to-date documentation, and ensuring post-registration compliance, medical device companies can contribute to a robust and reliable healthcare system in India.
If you need any support in getting CDSCO Registration, then you can 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 Interventional and Radiology Medical Devices?
Ans. CDSCO Registration for Interventional and Radiology Medical Devices is a mandatory regulatory process in India that ensures such devices are safe, effective, and meet the quality standards prescribed under the Medical Device Rules, 2017. Devices like MRI systems, X-ray machines, and Doppler ultrasound systems must be registered before being sold or used in India.
Q2. Who needs to apply for CDSCO Registration for Interventional and Radiology Medical Devices?
Ans. Both Indian manufacturers and foreign manufacturers (through an Indian Authorized Representative) need to apply for CDSCO registration if they produce or import interventional and radiology medical devices falling under the notified list issued by CDSCO.
Q3. What are the documents required for CDSCO Registration of these devices?
Ans. Essential documents include a duly filled application form, ISO 13485 certificate, CE Design Certificate, Free Sale Certificate, Plant Master Report, Device Master File, Declaration of Conformity, and an undertaking about the authenticity of submitted data.
Q4. How are Interventional and Radiology Medical Devices classified for registration?
Ans. These devices are classified based on their risk level:

Class A (low risk) – e.g., Nuclear Whole Body Scanner

Class B (moderate risk) – e.g., Ultrasonic Doppler Imaging System

Class C (moderate-high risk) – e.g., MRI Systems, CT Scanners

Class D (high risk) – e.g., Transilluminator for Breast Evaluation

Q5. What is the validity period of the CDSCO Registration Certificate?
Ans. The registration certificate issued by CDSCO for interventional and radiology medical devices is valid for 3 years from the date of issuance unless suspended or cancelled by the authority for regulatory violations or non-compliance.
Q6. Is CDSCO registration needed for non-notified interventional devices as well?
Ans. Yes, as per the February 2020 notification and subsequent updates, even non-notified interventional and radiology devices are required to be registered under CDSCO starting from April 1, 2020, based on their classification under the Medical Device Rules.
Q7. What happens if there is a change in the manufacturer’s company details after registration?
Ans. In case of any changes in company constitution or address, the Licensing Authority must be informed in writing. The existing certificate remains valid for 3 months from the date of change, during which the manufacturer or authorized representative must obtain a new registration certificate.

Interventional radiology plays an important role in diagnosing and treating a wide range of diseases. This branch of medicine utilizes minimally invasive techniques, which involve the insertion of small instruments such as catheters and wires, often guided by advanced imaging machines like CT scans, X-rays, and ultrasound. These procedures provide an alternative to open surgery, minimizing risks and reducing the patient’s hospital stay. Given the importance of such medical devices, the Central Drugs Standard Control Organisation (CDSCO) mandates a strict registration process for interventional and radiology medical devices to ensure their safety and effectiveness in India.

Risk-Based Classification of Medical Devices

On 3rd September 2020, the CDSCO issued a draft for the classification of non-notified medical devices. This move was initiated by the Ministry of Health and Family Welfare to bring all medical devices under regulation. For instance, items such as gowns, adhesive drapes, and coveralls are classified as Class A (low-risk), while surgical drapes and non-notified in-vitro diagnostics (IVDs) fall under Class B (low-moderate risk).

In February 2020, the Ministry made a significant regulatory change by releasing a formal definition of medical devices and including Chapter IIIA in the Medical Device Rules, 2017. This chapter made it compulsory for all manufacturers and importers of non-notified medical devices to register their products with CDSCO, effective from 1st April 2020.

Under Chapter II, Rule 3 of the Medical Device Rules, 2017, medical devices in India are classified based on the level of risk they pose to patients:

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

Each class determines the regulatory pathway, documentation, and approvals required for CDSCO Registration for Interventional and Radiology Medical Devices.

Categorization of Medical Devices

CDSCO has notified a wide range of medical device categories, and interventional and radiology devices are among them. The notification mandates that these categories of devices must be registered under the CDSCO regime. Some of the other categories include devices used in anesthesiology, pain management, cardiovascular treatments, dental care, ENT, gastroenterology, urology, general hospital use, operating theaters, and respiratory treatments.

Other categories also cover neurological, gynecological, ophthalmic, rehabilitation, dermatology, oncology, radiotherapy, nephrology, and software-driven devices. All these categories fall under the regulatory purview of CDSCO for registration and compliance.

Classification of Devices regarding Interventional and Radiology

The CDSCO has defined risk classes for individual interventional and radiology devices. These classifications determine the level of scrutiny and documentation required for CDSCO Registration for Interventional and Radiology Medical Devices. For example:

Devices such as Scintillation (gamma) cameras, positron cameras, and nuclear scanners are categorized under Class A, indicating low risk.
Diagnostic X-Ray systems, mammographic X-ray systems, and MRI systems are generally placed under Class C, indicating moderate to high risk.
Devices like ultrasonic Doppler imaging systems and diagnostic ultrasonic transducers are classified under Class B, showing moderate risk.

This classification ensures that the devices are thoroughly evaluated based on their potential impact on human health before they reach the market.

Documents Required for CDSCO Registration for Interventional and Radiology Medical Devices

For a successful registration with CDSCO, the manufacturer or importer must provide several essential documents. Each of these documents is critical for assessing the quality, safety, and compliance of the medical device:

A duly filled application form is required to initiate the registration process. This form includes vital details about the applicant, the device, and its specifications.
ISO 13485 Certificate demonstrates that the manufacturer follows international quality standards for medical device manufacturing.
Full Quality Assurance Certificate confirms the reliability of the manufacturing process and end-product quality.
CE Design Certificate is necessary if the device is manufactured in Europe and meets European safety and design standards.
An undertaking from the applicant confirming the authenticity of all information submitted is mandatory.
A Free Sale Certificate (FSC) or a certificate from the foreign government verifies that the device is freely sold in the country of origin.
The Plant Master Report provides an overview of the manufacturing site, processes, and facilities.
The Device Master File includes detailed technical specifications and information about the medical device.
A Declaration of Conformity affirms that the device complies with applicable regulatory requirements.

Procedure for CDSCO Registration for Interventional and Radiology Medical Devices

The CDSCO Registration for Interventional and Radiology Medical Devices follows a structured and step-wise process. Each step involves specific actions and documentation to ensure complete transparency and compliance.

Step 1: Identify Whether the Device is Notified Before applying for registration, the manufacturer or importer must first determine if the medical device is part of the notified list released by CDSCO. If it is a notified device, registration is mandatory. For non-notified or new devices, the applicant may be required to obtain a No Objection Certificate (NOC) before proceeding further.

Step 2: Appoint an Authorized Representative (For Foreign Manufacturers) Foreign manufacturers must appoint an Authorized Representative in India. This representative acts as the local point of contact for all regulatory communications. They are responsible for addressing queries from CDSCO, coordinating inspections, and ensuring that the product complies with Indian laws.

Step 3: Filing the Application Once the necessary documents are ready, the applicant must file the registration application through the CDSCO online portal. This includes uploading the regulatory dossier and paying the applicable registration fee. The application is then submitted to the Directorate General of Health Services (DGHS) for review.

Step 4: Registration Review and Approval CDSCO may raise queries during the review process. These could be requests for clarification or additional documentation. In some cases, the authority may even ask for a technical presentation or demonstration. If the CDSCO is satisfied with the provided details, it will issue a CDSCO Registration Certificate.

Note: The validity of the CDSCO Registration for Interventional and Radiology Medical Devices is three years from the date of issuance unless suspended or cancelled earlier by the authority.

Post-Compliance After Getting CDSCO Registration

Once the CDSCO Registration Certificate is granted, the manufacturer or importer must ensure continuous compliance with regulatory requirements.

If there is any change in the constitution of the company or the address of its registered office or manufacturing unit, the Licensing Authority must be informed in writing. This ensures that the CDSCO database is always updated with the correct information.

Moreover, when such changes occur, the existing registration certificate remains valid for only three months. Within this time, the applicant must apply for a new CDSCO Registration Certificate. Failure to do so can result in penalties or suspension of existing registration.

Conclusion

The medical device industry of India is growing with increasing reliance on technology-driven diagnostic and treatment solutions. Interventional and radiology medical devices form a crucial part of this ecosystem. Given their direct application to human health, it becomes essential for manufacturers and importers to follow the proper legal framework for bringing these devices into the Indian market.

CDSCO Registration for Interventional and Radiology Medical Devices not only ensures compliance with Indian laws but also guarantees that the devices used are safe, effective, and of high quality. By following the step-by-step registration process, maintaining up-to-date documentation, and ensuring post-registration compliance, medical device companies can contribute to a robust and reliable healthcare system in India.

If you need any support in getting CDSCO Registration, then you can 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 Interventional and Radiology Medical Devices?

Ans. CDSCO Registration for Interventional and Radiology Medical Devices is a mandatory regulatory process in India that ensures such devices are safe, effective, and meet the quality standards prescribed under the Medical Device Rules, 2017. Devices like MRI systems, X-ray machines, and Doppler ultrasound systems must be registered before being sold or used in India.

Q2. Who needs to apply for CDSCO Registration for Interventional and Radiology Medical Devices?

Ans. Both Indian manufacturers and foreign manufacturers (through an Indian Authorized Representative) need to apply for CDSCO registration if they produce or import interventional and radiology medical devices falling under the notified list issued by CDSCO.

Q3. What are the documents required for CDSCO Registration of these devices?

Ans. Essential documents include a duly filled application form, ISO 13485 certificate, CE Design Certificate, Free Sale Certificate, Plant Master Report, Device Master File, Declaration of Conformity, and an undertaking about the authenticity of submitted data.

Q4. How are Interventional and Radiology Medical Devices classified for registration?

Ans. These devices are classified based on their risk level:

Class A (low risk) – e.g., Nuclear Whole Body Scanner
Class B (moderate risk) – e.g., Ultrasonic Doppler Imaging System
Class C (moderate-high risk) – e.g., MRI Systems, CT Scanners
Class D (high risk) – e.g., Transilluminator for Breast Evaluation

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

Ans. The registration certificate issued by CDSCO for interventional and radiology medical devices is valid for 3 years from the date of issuance unless suspended or cancelled by the authority for regulatory violations or non-compliance.

Q6. Is CDSCO registration needed for non-notified interventional devices as well?

Ans. Yes, as per the February 2020 notification and subsequent updates, even non-notified interventional and radiology devices are required to be registered under CDSCO starting from April 1, 2020, based on their classification under the Medical Device Rules.

Q7. What happens if there is a change in the manufacturer’s company details after registration?

Ans. In case of any changes in company constitution or address, the Licensing Authority must be informed in writing. The existing certificate remains valid for 3 months from the date of change, during which the manufacturer or authorized representative must obtain a new registration certificate.