CDSCO Registration for Radiotherapy Medical Devices

CDSCO Registration for Radiotherapy Medical Devices. The healthcare sector in India has evolved quickly, with medical devices playing an important role in modern treatment methods. Among these, radiotherapy medical devices are essential in the treatment of cancer and other serious conditions. To ensure these devices meet safety and quality standards, the Central Drugs Standard Control Organization (CDSCO) has mandated their registration under the Medical Device Rules, 2017. This article gives an explanation of the CDSCO Registration for Radiotherapy Medical Devices, highlighting regulations, classification, registration procedures, and documentation requirements.
Background on Medical Device Regulations in India
Prior to 2006, the medical device sector in India operated without structured regulatory oversight. Devices were marketed without any certification, which posed significant risks to patient safety. Recognizing this gap, the Government of India, through the CDSCO, introduced regulations for the medical device industry. Initially, only a limited set of devices were subject to mandatory registration.
On 3rd September 2020, a landmark notification was issued that included 24 new medical device categories requiring mandatory registration under CDSCO. This list included radiotherapy medical devices, reflecting the increasing need to monitor and regulate advanced therapeutic technologies.
CDSCO Classification of Medical Devices
CDSCO classifies medical devices into two categories:

Notified Medical Devices

Non-Notified Medical Devices

Initially, only notified medical devices required mandatory registration. However, as of the latest notifications, the scope has expanded to include a wider range of medical equipment.
On 1st April 2020, Notification 648(E) was issued, stating that all instruments, apparatus, appliances, materials, implants, or any tools used either alone or with another accessory for human or animal use would be classified as drugs if they fulfill specific medical functions without achieving their primary action through immunological, pharmacological, or metabolic means.
These include purposes such as:

Diagnosing or treating disease or injury

Replacing or supporting physiological functions

Life support

Contraception

Device disinfection

Notification for Radiotherapy Medical Devices
In continuation of these regulatory updates, CDSCO issued another notification on 3rd September 2020, which listed 24 new categories of medical devices, making their registration mandatory. This included Radiotherapy Medical Devices.
Further, on 6th August 2021, the Drugs Controller General of India notified the classification of radiotherapy devices under the Medical Device Rules, 2017. A total of 101 specific radiotherapy-related devices were identified and classified based on their associated risk classes (A, B, C, and D).
Risk Classification of Radiotherapy Medical Devices
Each radiotherapy medical device is assigned a risk class that determines the level of scrutiny required for registration and usage. The classification of medical devices are:

Class A – Low risk

Class B – Low to moderate risk

Class C – Moderate to high risk

Class D – High risk

Examples:

"Medical charged particle radiation therapy system" is classified as Class C.

"Absorbable tissue spacer for radiotherapy" falls under Class D.

"Light beam patient position indicator" is classified under Class A.

A detailed table was issued listing all 101 devices with corresponding risk classifications to guide manufacturers and healthcare facilities in compliance.
CDSCO Regulation on Radiotherapy Medical Devices
The inclusion of radiotherapy medical devices under CDSCO regulations ensures strict oversight in terms of device quality, design, and usage safety. With such devices being pivotal in cancer therapy, radiation planning, and patient care, the CDSCO's regulatory framework aims to prevent risks associated with substandard or unapproved devices.
Manufacturers must align their products with the standards mentioned in the Medical Device Rules, 2017. This applies to both imported and domestically manufactured radiotherapy devices.
Documents Required for CDSCO Registration for Radiotherapy Medical Devices
To obtain CDSCO Registration for Radiotherapy Medical Devices, the applicant must submit the following documents:

Application Form: The prescribed form must be duly filled with all technical and administrative details.

ISO 13485 Certificate: Demonstrates compliance with international quality management standards.

Undertaking: A self-declaration that all information provided is accurate.

TR6 Challan: Proof of payment of government fees.

Power of Attorney: Authorizes a representative to submit and manage the application.

Full Quality Assurance Certificate: Confirms that the manufacturing process meets required safety and performance standards.

Schedule D(I): Required for imported devices.

CE Certificate: Shows conformity with European Union regulations.

Declaration of Conformity: Confirms compliance with applicable standards.

Plant Master File: Contains detailed manufacturing facility information.

Device Master File: Describes the device, including specifications, intended use, and labelling.

Free Sale Certificate: Indicates that the device is freely sold in the country of origin.

These documents ensure that the medical device meets stringent quality, safety, and performance parameters before being approved for sale or use in India.
Procedure for CDSCO Registration for Radiotherapy Medical Devices
Step 1: Identify Device Classification
The applicant must determine whether the radiotherapy device is classified as notified or non-notified. In this case, radiotherapy devices fall under the notified category, hence requiring mandatory registration.
Step 2: Appoint an Indian Authorized Agent (IAA)
If the manufacturer is not based in India, they must appoint an Indian Authorized Agent. The IAA will act on behalf of the foreign manufacturer to complete the registration process.
Step 3: Prepare Documentation
The manufacturer or IAA must compile and submit all required documents to the CDSCO. It is important that all submissions are accurate and conform to the required formats and guidelines.
Step 4: Submission and Review
The CDSCO reviews the submitted documentation. If any discrepancies are found, clarification may be sought. The process includes a thorough evaluation of the quality, design, and compliance measures adopted by the manufacturer.
Step 5: Grant of Registration Certificate
After successful verification and satisfaction of all requirements, the CDSCO issues the registration certificate. The device can now be legally marketed or used in the Indian medical system.
Importance of CDSCO Registration for Radiotherapy Medical Devices
Radiotherapy devices directly affect patient health outcomes. An unregistered or non-compliant device could lead to serious medical errors or treatment failures. Therefore, obtaining CDSCO registration ensures:

Compliance with national safety regulations

Prevention of counterfeit or substandard devices

Improved trust among healthcare professionals and patients

Streamlined import and marketing approval process

Enhanced manufacturer accountability

Conclusion
The CDSCO Registration for Radiotherapy Medical Devices is a mandatory regulatory requirement that ensures the safety and effectiveness of devices used in critical healthcare procedures. The comprehensive list of devices and their classification, along with clearly defined documentation and registration processes, helps maintain industry standards and protects patient safety.
Given the technical complexity and strong requirements of the process, manufacturers and importers are encouraged to consult experienced regulatory professionals. Timely and correct registration not only avoids penalties and delays but also builds trust in the brand and product quality among stakeholders across India’s growing medical device industry.
If you need any help in CDSCO Registration, then you can book a consultation with the experts at Compliance Calendar LLP through email info@ccoffice.in or Call/Whatsapp at +91 9988424211.
FAQs 
Q1. What is CDSCO Registration for Radiotherapy Medical Devices?
Ans. CDSCO Registration is a mandatory regulatory approval by the Central Drugs Standard Control Organisation (CDSCO) for importing, manufacturing, or selling radiotherapy medical devices in India. It ensures these devices meet quality, safety, and performance standards set under the Medical Devices Rules, 2017.
Q2. Is CDSCO Registration mandatory for all radiotherapy equipment in India?
Ans. Yes, as per the Medical Devices Rules, 2017, all radiotherapy medical devices notified by the Ministry of Health & Family Welfare must be registered with CDSCO. This includes devices like linear accelerators, cobalt therapy units, and brachytherapy systems.
Q3. Who can apply for CDSCO Registration of radiotherapy devices?
Ans. Manufacturers (domestic or foreign), authorized Indian agents (for foreign manufacturers), and importers can apply for CDSCO registration. Foreign entities must appoint an Indian Authorized Representative (AIR) to liaise with CDSCO.
Q4. What are the documents required for CDSCO registration of radiotherapy devices?
Ans. Key documents include:

Device Master File (DMF)

Plant Master File (PMF)

Free Sale Certificate (for imports)

ISO 13485 certificate

Notified Body Certificate (if applicable)

Undertaking and power of attorney (for foreign applicants)

Test reports and clinical data (if required)

Q5. What is the process to register radiotherapy medical devices with CDSCO?
Ans. The registration process involves:

Classification of the device under the correct CDSCO risk category.

Preparing and submitting an online application via CDSCO SUGAM portal.

Uploading required documents and paying the applicable fees.

CDSCO scrutiny and, if needed, request for additional information or inspections.

Grant of registration/license upon approval.

Q6. What is the validity period of a CDSCO license for radiotherapy devices?
Ans. Once issued, a CDSCO license is typically valid for five years, subject to compliance with ongoing regulatory requirements and timely renewal before expiration.
Q7. What happens if a radiotherapy device is sold without CDSCO approval?
Ans. Selling or distributing radiotherapy medical devices without CDSCO registration is illegal and may attract penalties, including product seizure, cancellation of license, and legal action under the Drugs and Cosmetics Act, 1940 and Medical Devices Rules, 2017.

The healthcare sector in India has evolved quickly, with medical devices playing an important role in modern treatment methods. Among these, radiotherapy medical devices are essential in the treatment of cancer and other serious conditions. To ensure these devices meet safety and quality standards, the Central Drugs Standard Control Organization (CDSCO) has mandated their registration under the Medical Device Rules, 2017. This article gives an explanation of the CDSCO Registration for Radiotherapy Medical Devices, highlighting regulations, classification, registration procedures, and documentation requirements.

Background on Medical Device Regulations in India

Prior to 2006, the medical device sector in India operated without structured regulatory oversight. Devices were marketed without any certification, which posed significant risks to patient safety. Recognizing this gap, the Government of India, through the CDSCO, introduced regulations for the medical device industry. Initially, only a limited set of devices were subject to mandatory registration.

On 3rd September 2020, a landmark notification was issued that included 24 new medical device categories requiring mandatory registration under CDSCO. This list included radiotherapy medical devices, reflecting the increasing need to monitor and regulate advanced therapeutic technologies.

CDSCO Classification of Medical Devices

CDSCO classifies medical devices into two categories:

Notified Medical Devices
Non-Notified Medical Devices

Initially, only notified medical devices required mandatory registration. However, as of the latest notifications, the scope has expanded to include a wider range of medical equipment.

On 1st April 2020, Notification 648(E) was issued, stating that all instruments, apparatus, appliances, materials, implants, or any tools used either alone or with another accessory for human or animal use would be classified as drugs if they fulfill specific medical functions without achieving their primary action through immunological, pharmacological, or metabolic means.

These include purposes such as:

Diagnosing or treating disease or injury
Replacing or supporting physiological functions
Life support
Contraception
Device disinfection

Notification for Radiotherapy Medical Devices

In continuation of these regulatory updates, CDSCO issued another notification on 3rd September 2020, which listed 24 new categories of medical devices, making their registration mandatory. This included Radiotherapy Medical Devices.

Further, on 6th August 2021, the Drugs Controller General of India notified the classification of radiotherapy devices under the Medical Device Rules, 2017. A total of 101 specific radiotherapy-related devices were identified and classified based on their associated risk classes (A, B, C, and D).

Risk Classification of Radiotherapy Medical Devices

Each radiotherapy medical device is assigned a risk class that determines the level of scrutiny required for registration and usage. The classification of medical devices are:

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

Examples:

"Medical charged particle radiation therapy system" is classified as Class C.
"Absorbable tissue spacer for radiotherapy" falls under Class D.
"Light beam patient position indicator" is classified under Class A.

A detailed table was issued listing all 101 devices with corresponding risk classifications to guide manufacturers and healthcare facilities in compliance.

CDSCO Regulation on Radiotherapy Medical Devices

The inclusion of radiotherapy medical devices under CDSCO regulations ensures strict oversight in terms of device quality, design, and usage safety. With such devices being pivotal in cancer therapy, radiation planning, and patient care, the CDSCO's regulatory framework aims to prevent risks associated with substandard or unapproved devices.

Manufacturers must align their products with the standards mentioned in the Medical Device Rules, 2017. This applies to both imported and domestically manufactured radiotherapy devices.

Documents Required for CDSCO Registration for Radiotherapy Medical Devices

To obtain CDSCO Registration for Radiotherapy Medical Devices, the applicant must submit the following documents:

Application Form: The prescribed form must be duly filled with all technical and administrative details.
ISO 13485 Certificate: Demonstrates compliance with international quality management standards.
Undertaking: A self-declaration that all information provided is accurate.
TR6 Challan: Proof of payment of government fees.
Power of Attorney: Authorizes a representative to submit and manage the application.
Full Quality Assurance Certificate: Confirms that the manufacturing process meets required safety and performance standards.
Schedule D(I): Required for imported devices.
CE Certificate: Shows conformity with European Union regulations.
Declaration of Conformity: Confirms compliance with applicable standards.
Plant Master File: Contains detailed manufacturing facility information.
Device Master File: Describes the device, including specifications, intended use, and labelling.
Free Sale Certificate: Indicates that the device is freely sold in the country of origin.

These documents ensure that the medical device meets stringent quality, safety, and performance parameters before being approved for sale or use in India.

Procedure for CDSCO Registration for Radiotherapy Medical Devices

Step 1: Identify Device Classification

The applicant must determine whether the radiotherapy device is classified as notified or non-notified. In this case, radiotherapy devices fall under the notified category, hence requiring mandatory registration.

Step 2: Appoint an Indian Authorized Agent (IAA)

If the manufacturer is not based in India, they must appoint an Indian Authorized Agent. The IAA will act on behalf of the foreign manufacturer to complete the registration process.

Step 3: Prepare Documentation

The manufacturer or IAA must compile and submit all required documents to the CDSCO. It is important that all submissions are accurate and conform to the required formats and guidelines.

Step 4: Submission and Review

The CDSCO reviews the submitted documentation. If any discrepancies are found, clarification may be sought. The process includes a thorough evaluation of the quality, design, and compliance measures adopted by the manufacturer.

Step 5: Grant of Registration Certificate

After successful verification and satisfaction of all requirements, the CDSCO issues the registration certificate. The device can now be legally marketed or used in the Indian medical system.

Importance of CDSCO Registration for Radiotherapy Medical Devices

Radiotherapy devices directly affect patient health outcomes. An unregistered or non-compliant device could lead to serious medical errors or treatment failures. Therefore, obtaining CDSCO registration ensures:

Compliance with national safety regulations
Prevention of counterfeit or substandard devices
Improved trust among healthcare professionals and patients
Streamlined import and marketing approval process
Enhanced manufacturer accountability

Conclusion

The CDSCO Registration for Radiotherapy Medical Devices is a mandatory regulatory requirement that ensures the safety and effectiveness of devices used in critical healthcare procedures. The comprehensive list of devices and their classification, along with clearly defined documentation and registration processes, helps maintain industry standards and protects patient safety.

Given the technical complexity and strong requirements of the process, manufacturers and importers are encouraged to consult experienced regulatory professionals. Timely and correct registration not only avoids penalties and delays but also builds trust in the brand and product quality among stakeholders across India’s growing medical device industry.

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

FAQs

Q1. What is CDSCO Registration for Radiotherapy Medical Devices?

Ans. CDSCO Registration is a mandatory regulatory approval by the Central Drugs Standard Control Organisation (CDSCO) for importing, manufacturing, or selling radiotherapy medical devices in India. It ensures these devices meet quality, safety, and performance standards set under the Medical Devices Rules, 2017.

Q2. Is CDSCO Registration mandatory for all radiotherapy equipment in India?

Ans. Yes, as per the Medical Devices Rules, 2017, all radiotherapy medical devices notified by the Ministry of Health & Family Welfare must be registered with CDSCO. This includes devices like linear accelerators, cobalt therapy units, and brachytherapy systems.

Q3. Who can apply for CDSCO Registration of radiotherapy devices?

Ans. Manufacturers (domestic or foreign), authorized Indian agents (for foreign manufacturers), and importers can apply for CDSCO registration. Foreign entities must appoint an Indian Authorized Representative (AIR) to liaise with CDSCO.

Q4. What are the documents required for CDSCO registration of radiotherapy devices?

Ans. Key documents include:

Device Master File (DMF)
Plant Master File (PMF)
Free Sale Certificate (for imports)
ISO 13485 certificate
Notified Body Certificate (if applicable)
Undertaking and power of attorney (for foreign applicants)
Test reports and clinical data (if required)

Q5. What is the process to register radiotherapy medical devices with CDSCO?

Ans. The registration process involves:

Classification of the device under the correct CDSCO risk category.
Preparing and submitting an online application via CDSCO SUGAM portal.
Uploading required documents and paying the applicable fees.
CDSCO scrutiny and, if needed, request for additional information or inspections.
Grant of registration/license upon approval.

Q6. What is the validity period of a CDSCO license for radiotherapy devices?

Ans. Once issued, a CDSCO license is typically valid for five years, subject to compliance with ongoing regulatory requirements and timely renewal before expiration.

Q7. What happens if a radiotherapy device is sold without CDSCO approval?

Ans. Selling or distributing radiotherapy medical devices without CDSCO registration is illegal and may attract penalties, including product seizure, cancellation of license, and legal action under the Drugs and Cosmetics Act, 1940 and Medical Devices Rules, 2017.