CDSCO Registration for MRI Machine In India

CDSCO Registration for MRI Machine In India. The Central Drugs Standard Control Organization (CDSCO) is the national regulatory authority for pharmaceuticals and medical devices in India. It functions under the Directorate General of Health Services (DGHS), Ministry of Health & Family Welfare. CDSCO ensures that medical devices sold in India are safe, effective, and of high quality. On April 18, 2021, CDSCO issued a notification declaring that all implanted devices and diagnostic machines like MRI, CT scans, PET, dialysis equipment, and defibrillators would be treated as "drugs" under the Drugs and Cosmetics Act. This move brought these devices under the Medical Devices Rules (MDR), 2017. This article provides a complete knowledge about CDSCO Registration process for MRI Machines, including the types of MRI machines, required documentation, classification, regulatory framework, step-by-step application process, and timelines involved.
What is an MRI Machine?
MRI (Magnetic Resonance Imaging) is a non-invasive diagnostic imaging technique that produces detailed three-dimensional images of the internal organs, tissues, and structures of the body. It operates on the principle of nuclear magnetic resonance. MRI uses powerful magnets and radio waves to excite hydrogen atoms in the body, primarily those in water molecules. These excited atoms emit radio waves, which are captured by sensors and converted into high-resolution images by a computer system.
MRI is widely used for brain scans, spinal imaging, musculoskeletal evaluations, and detection of tumors and internal bleeding. It does not use ionizing radiation, making it safer than CT scans in many cases. During the MRI procedure, patients are required to lie still inside a large cylindrical machine. Sometimes, intravenous contrast agents, typically gadolinium-based, are administered to improve image clarity.
Types of MRI Machines
MRI machines are available in different configurations depending on their design and intended use. The two most common types are:
1. Closed Bore MRI
Closed bore MRI machines have a narrow cylindrical tunnel where the patient is placed. These machines offer high-quality imaging and are widely used in hospitals and diagnostic centers. However, the enclosed space may cause discomfort to claustrophobic patients.
2. Open Bore MRI
Open bore MRI machines have a more open design with magnets placed above and below the patient. This type is more comfortable for patients with anxiety or claustrophobia. However, the image resolution may not be as high as that of closed bore systems.
Classification of Medical Devices under CDSCO
Medical devices in India are categorized into notified and non-notified devices and are further classified based on the level of risk associated with their use.
Notified Medical Devices
These are devices listed under the Medical Devices Rules, 2017, for which registration is mandatory. Currently, 37 types of medical devices are notified.
Non-Notified Medical Devices
These include a broader set of devices that were not previously under mandatory registration but now require approval following recent CDSCO amendments. MRI machines fall into this category.
Risk-Based Classification for MRI Machine
CDSCO classifies medical devices based on the potential risk they pose to patients:

Class
Risk Level
Examples

A
Low 
Surgical dressings, thermometers

B 
Moderate low
Blood pressure monitors, pregnancy kits

C 
Moderate high
MRI Machines, Anaesthesia machines

D 
High 
Pacemakers, Heart-Lung Bypass machines

MRI machines are classified as Class C devices due to their high magnetic field strength, use of contrast agents, and sophisticated technology. Hence, the registration and licensing process is more stringent for these devices.
Forms Required for MRI Machine Registration
For Manufacturers:
• Form MD-7: For obtaining manufacturing license.
• Form MD-9: License issued post-approval.
• Fees: Rs.50,000 per site and Rs.1,000 per device.
For Manufacturers (Loan License):
• Form MD-8: Application form.
• Form MD-10: License issued under loan license provision.
For Importers:
• Form MD-14: Import application.
• Form MD-15: Import license.
Documents Required for MRI Machine Registration
For Manufacturers:
1. Cover Letter.
2. Application Fees Proof.
3. Company Constitution Details.
4. Site Ownership or Tenancy Agreement.
5. ISO 13485 Certificate.
6. Quality Management System Documents as per MDR 2017.
7. Plant Master File (PMF).
8. Device Master File (DMF).
9. Test License (for domestic manufacturing).
10. Undertaking regarding compliance with MDR 2017.
11. Predicate Device Reference (if applicable).
For Importers:
1. Cover Letter.
2. Power of Attorney.
3. Wholesale License of Indian Agent.
4. Free Sale Certificate from Country of Origin.
5. Additional FSCs from countries like USA, UK, EU, Japan, Australia, Canada.
6. Audit or Inspection Reports.
7. ISO and CE Certificates.
8. Declaration of Conformity.
9. Label and Instructions for Use (IFU).
10. Plant Master File.
11. Device Master File.
12. Constitution Details of Authorized Indian Agent.
Step-by-Step CDSCO Registration Process for MRI Machine
The following is the complete process for CDSCO Registration for MRI Machine:
Step 1: Identify Medical Device Classification
The applicant must determine if the MRI machine is a notified or non-notified device. As per CDSCO notification dated April 18, 2021, MRI machines are considered non-notified but still require registration.
Step 2: Risk-Based Classification
MRI machines are classified as Class C devices due to the moderate to high risk involved in their use.
Step 3: Submit Application Form
The applicant must submit the relevant application form depending on the purpose:
• Form MD-7 for manufacturing.
• Form MD-8 for loan license manufacturing.
• Form MD-14 for import license.
Step 4: Appointment of Indian Authorized Agent
Foreign manufacturers must appoint an Indian authorized agent under MDR 2017 to represent them in all matters related to CDSCO licensing.
Step 5: Submission of Documents
Applicants must prepare and upload all necessary documents, including technical, legal, and quality assurance files.
Step 6: Site Inspection and Audit
For Class C domestic manufacturers, a site audit is conducted by a notified body within 60 days of submission. The audit report is forwarded to the Central Licensing Authority (CLA) within 30 days. For importers, audit reports are submitted from foreign inspections or previous audits. If required, CLA may conduct its own inspection at the importer’s expense.
Step 7: License Issuance
Upon successful evaluation of documents and inspection reports, the CDSCO issues:
• Form MD-9: Manufacturing license.
• Form MD-10: Loan license.
• Form MD-15: Import license.
Step 8: Market Authorization
Once the license is issued, the MRI machines can be imported or manufactured and distributed across the Indian market.
Time Required for CDSCO Registration
The average time taken for CDSCO to approve a medical device registration application for MRI machines is 3 to 4 months from the date of application submission. If the application requires a technical presentation or subject expert committee (SEC) review, it may take an additional 3 to 6 months.
Renewal of CDSCO License for MRI Machine
The registration certificate is valid for a specified period, after which it must be renewed. The renewal application must be filed at least nine months before the license expiry date. No major changes in documentation are required unless there are changes in the Device Master File (DMF) or Plant Master File (PMF). In such cases, updated documents must be submitted. If there are no changes, existing documents can be re-submitted with the renewal application.
Importance of CDSCO License for MRI Machines
Obtaining a CDSCO license ensures that the MRI machine complies with Indian safety and performance standards. The registration process validates that the machine is manufactured or imported with appropriate quality control systems and is safe for use. CDSCO's monitoring ensures public health protection and transparency in the medical device industry.
Conclusion
The Indian medical device market is growing rapidly, and MRI machines play a crucial role in diagnostic imaging. According to market estimates, the MRI machine segment stood at $251.59 million in 2022 and is projected to grow at a CAGR of 6% until 2027. To capture a share of this expanding market, manufacturers and importers must ensure timely registration and compliance with CDSCO regulations. A valid license not only provides market access but also boosts credibility and patient trust. With proper documentation, adherence to quality standards, and expert guidance, the CDSCO registration process for MRI machines can be completed smoothly.
If you need any support in obtaining CDSCO Registration Certificate, then you can connect with the experts through mail info@ccoffice.in or Call/Whatsapp at +91 9988424211.
Frequently Asked Questions (FAQs)
Q1. Why is CDSCO registration necessary for MRI machines in India? 
Ans. CDSCO registration is mandatory because MRI machines are classified as medical devices in India. This regulatory oversight by the Central Drugs Standard Control Organization (CDSCO) ensures their safety, quality, and performance within the healthcare sector.
Q2. What is the primary role of CDSCO in relation to MRI machines? 
Ans. CDSCO, as the primary regulatory body in India, is responsible for overseeing the registration of medical devices, including MRI machines. This involves establishing the framework, classifying the devices, outlining the registration process, defining required documentation, and managing the renewal procedure.
Q3. What are the key applications of MRI technology in the healthcare sector? 
Ans. MRI plays a critical role in diagnosing various medical conditions, particularly in areas such as: neurological disorders (tumors, strokes, spinal cord injuries), musculoskeletal diseases (joint, ligament, and muscle injuries), cardiovascular diseases (heart conditions and blood vessel abnormalities), and oncology (detection of various types of cancer).
Q4. What is the current market size and projected growth of the MRI machine market in India? 
Ans. The Indian MRI machine market is currently valued at USD 308.03 million and is projected to grow at a CAGR of 6.11% between 2024 and 2029, reaching USD 414.35 million by 2029. This growth is primarily driven by the expansion of healthcare infrastructure and the increasing adoption of advanced MRI machines.
Q5. What factors are contributing to the growth and demand for MRI machines in India? 
Ans. Several factors are fueling the growth of the MRI market in India, including the expansion of healthcare infrastructure, the increasing prevalence of chronic conditions like Alzheimer's and brain injuries, and the technological advancements leading to very-high-field MRI systems with enhanced image quality and diagnostic capabilities.

The Central Drugs Standard Control Organization (CDSCO) is the national regulatory authority for pharmaceuticals and medical devices in India. It functions under the Directorate General of Health Services (DGHS), Ministry of Health & Family Welfare. CDSCO ensures that medical devices sold in India are safe, effective, and of high quality. On April 18, 2021, CDSCO issued a notification declaring that all implanted devices and diagnostic machines like MRI, CT scans, PET, dialysis equipment, and defibrillators would be treated as "drugs" under the Drugs and Cosmetics Act. This move brought these devices under the Medical Devices Rules (MDR), 2017. This article provides a complete knowledge about CDSCO Registration process for MRI Machines, including the types of MRI machines, required documentation, classification, regulatory framework, step-by-step application process, and timelines involved.

What is an MRI Machine?

MRI (Magnetic Resonance Imaging) is a non-invasive diagnostic imaging technique that produces detailed three-dimensional images of the internal organs, tissues, and structures of the body. It operates on the principle of nuclear magnetic resonance. MRI uses powerful magnets and radio waves to excite hydrogen atoms in the body, primarily those in water molecules. These excited atoms emit radio waves, which are captured by sensors and converted into high-resolution images by a computer system.

MRI is widely used for brain scans, spinal imaging, musculoskeletal evaluations, and detection of tumors and internal bleeding. It does not use ionizing radiation, making it safer than CT scans in many cases. During the MRI procedure, patients are required to lie still inside a large cylindrical machine. Sometimes, intravenous contrast agents, typically gadolinium-based, are administered to improve image clarity.

Types of MRI Machines

MRI machines are available in different configurations depending on their design and intended use. The two most common types are:

1. Closed Bore MRI

Closed bore MRI machines have a narrow cylindrical tunnel where the patient is placed. These machines offer high-quality imaging and are widely used in hospitals and diagnostic centers. However, the enclosed space may cause discomfort to claustrophobic patients.

2. Open Bore MRI

Open bore MRI machines have a more open design with magnets placed above and below the patient. This type is more comfortable for patients with anxiety or claustrophobia. However, the image resolution may not be as high as that of closed bore systems.

Classification of Medical Devices under CDSCO

Medical devices in India are categorized into notified and non-notified devices and are further classified based on the level of risk associated with their use.

Notified Medical Devices

These are devices listed under the Medical Devices Rules, 2017, for which registration is mandatory. Currently, 37 types of medical devices are notified.

Non-Notified Medical Devices

These include a broader set of devices that were not previously under mandatory registration but now require approval following recent CDSCO amendments. MRI machines fall into this category.

Risk-Based Classification for MRI Machine

CDSCO classifies medical devices based on the potential risk they pose to patients:

Class	Risk Level	Examples
A	Low	Surgical dressings, thermometers
B	Moderate low	Blood pressure monitors, pregnancy kits
C	Moderate high	MRI Machines, Anaesthesia machines
D	High	Pacemakers, Heart-Lung Bypass machines

Forms Required for MRI Machine Registration

For Manufacturers:

• Form MD-7: For obtaining manufacturing license.

• Form MD-9: License issued post-approval.

• Fees: Rs.50,000 per site and Rs.1,000 per device.

For Manufacturers (Loan License):

• Form MD-8: Application form.

• Form MD-10: License issued under loan license provision.

For Importers:

• Form MD-14: Import application.

• Form MD-15: Import license.

Documents Required for MRI Machine Registration

For Manufacturers:

1. Cover Letter.

2. Application Fees Proof.

3. Company Constitution Details.

4. Site Ownership or Tenancy Agreement.

5. ISO 13485 Certificate.

6. Quality Management System Documents as per MDR 2017.

7. Plant Master File (PMF).

8. Device Master File (DMF).

9. Test License (for domestic manufacturing).

10. Undertaking regarding compliance with MDR 2017.

11. Predicate Device Reference (if applicable).

For Importers:

1. Cover Letter.

2. Power of Attorney.

3. Wholesale License of Indian Agent.

4. Free Sale Certificate from Country of Origin.

5. Additional FSCs from countries like USA, UK, EU, Japan, Australia, Canada.

6. Audit or Inspection Reports.

7. ISO and CE Certificates.

8. Declaration of Conformity.

9. Label and Instructions for Use (IFU).

10. Plant Master File.

11. Device Master File.

12. Constitution Details of Authorized Indian Agent.

Step-by-Step CDSCO Registration Process for MRI Machine

The following is the complete process for CDSCO Registration for MRI Machine:

Step 1: Identify Medical Device Classification

The applicant must determine if the MRI machine is a notified or non-notified device. As per CDSCO notification dated April 18, 2021, MRI machines are considered non-notified but still require registration.

Step 2: Risk-Based Classification

MRI machines are classified as Class C devices due to the moderate to high risk involved in their use.

Step 3: Submit Application Form

The applicant must submit the relevant application form depending on the purpose:

• Form MD-7 for manufacturing.

• Form MD-8 for loan license manufacturing.

• Form MD-14 for import license.

Step 4: Appointment of Indian Authorized Agent

Foreign manufacturers must appoint an Indian authorized agent under MDR 2017 to represent them in all matters related to CDSCO licensing.

Step 5: Submission of Documents

Applicants must prepare and upload all necessary documents, including technical, legal, and quality assurance files.

Step 6: Site Inspection and Audit

For Class C domestic manufacturers, a site audit is conducted by a notified body within 60 days of submission. The audit report is forwarded to the Central Licensing Authority (CLA) within 30 days. For importers, audit reports are submitted from foreign inspections or previous audits. If required, CLA may conduct its own inspection at the importer’s expense.

Step 7: License Issuance

Upon successful evaluation of documents and inspection reports, the CDSCO issues:

• Form MD-9: Manufacturing license.

• Form MD-10: Loan license.

• Form MD-15: Import license.

Step 8: Market Authorization

Once the license is issued, the MRI machines can be imported or manufactured and distributed across the Indian market.

Time Required for CDSCO Registration

The average time taken for CDSCO to approve a medical device registration application for MRI machines is 3 to 4 months from the date of application submission. If the application requires a technical presentation or subject expert committee (SEC) review, it may take an additional 3 to 6 months.

Renewal of CDSCO License for MRI Machine

The registration certificate is valid for a specified period, after which it must be renewed. The renewal application must be filed at least nine months before the license expiry date. No major changes in documentation are required unless there are changes in the Device Master File (DMF) or Plant Master File (PMF). In such cases, updated documents must be submitted. If there are no changes, existing documents can be re-submitted with the renewal application.

Importance of CDSCO License for MRI Machines

Obtaining a CDSCO license ensures that the MRI machine complies with Indian safety and performance standards. The registration process validates that the machine is manufactured or imported with appropriate quality control systems and is safe for use. CDSCO's monitoring ensures public health protection and transparency in the medical device industry.

Conclusion

The Indian medical device market is growing rapidly, and MRI machines play a crucial role in diagnostic imaging. According to market estimates, the MRI machine segment stood at $251.59 million in 2022 and is projected to grow at a CAGR of 6% until 2027. To capture a share of this expanding market, manufacturers and importers must ensure timely registration and compliance with CDSCO regulations. A valid license not only provides market access but also boosts credibility and patient trust. With proper documentation, adherence to quality standards, and expert guidance, the CDSCO registration process for MRI machines can be completed smoothly.

If you need any support in obtaining CDSCO Registration Certificate, then you can connect with the experts through mail info@ccoffice.in or Call/Whatsapp at +91 9988424211.

Frequently Asked Questions (FAQs)

Q1. Why is CDSCO registration necessary for MRI machines in India?

Ans. CDSCO registration is mandatory because MRI machines are classified as medical devices in India. This regulatory oversight by the Central Drugs Standard Control Organization (CDSCO) ensures their safety, quality, and performance within the healthcare sector.

Q2. What is the primary role of CDSCO in relation to MRI machines?

Ans. CDSCO, as the primary regulatory body in India, is responsible for overseeing the registration of medical devices, including MRI machines. This involves establishing the framework, classifying the devices, outlining the registration process, defining required documentation, and managing the renewal procedure.

Q3. What are the key applications of MRI technology in the healthcare sector?

Ans. MRI plays a critical role in diagnosing various medical conditions, particularly in areas such as: neurological disorders (tumors, strokes, spinal cord injuries), musculoskeletal diseases (joint, ligament, and muscle injuries), cardiovascular diseases (heart conditions and blood vessel abnormalities), and oncology (detection of various types of cancer).

Q4. What is the current market size and projected growth of the MRI machine market in India?

Ans. The Indian MRI machine market is currently valued at USD 308.03 million and is projected to grow at a CAGR of 6.11% between 2024 and 2029, reaching USD 414.35 million by 2029. This growth is primarily driven by the expansion of healthcare infrastructure and the increasing adoption of advanced MRI machines.

Q5. What factors are contributing to the growth and demand for MRI machines in India?

Ans. Several factors are fueling the growth of the MRI market in India, including the expansion of healthcare infrastructure, the increasing prevalence of chronic conditions like Alzheimer's and brain injuries, and the technological advancements leading to very-high-field MRI systems with enhanced image quality and diagnostic capabilities.