CDSCO Registration for MRI Machines in India – Start Your Application Now

CDSCO registration for MRI machines in India is a mandatory step for any manufacturer, importer, or distributor seeking to introduce magnetic resonance imaging (MRI) devices into the Indian market. The Central Drugs Standard Control Organisation (CDSCO) regulates all medical devices in India under the Medical Device Rules, 2017. Since MRI machines use powerful magnets and radio waves to produce detailed images of the body, they are classified as high‑risk medical devices. Proper CDSCO registration ensures these machines meet safety, quality, and performance standards before they reach hospitals and clinics.

What Is CDSCO Registration and Why Is It Needed for MRI Machines?

CDSCO registration is an official approval granted by India’s national drug and device authority. For MRI machines, registration is essential because:

• Safety Assurance: Verifies the machine’s electrical, magnetic, and radio‑frequency safety.
• Quality Control: Ensures manufacturing and performance meet global standards.
• Legal Compliance: Prevents importation or sale of unapproved devices, avoiding penalties.
• Public Trust: Hospitals and patients can have confidence in the accuracy of imaging results.

Who Must Apply for CDSCO Registration for MRI Machines?

S.No.	Stakeholder	Responsibility
1.	Foreign Manufacturer	Appoint an authorized Indian agent and apply.
2.	Indian Importer	Apply for an import license (Form MD‑14) and registration.
3.	Domestic Manufacturer	File for device registration (Form MD‑42) before sales.
4.	Authorized Distributor	Ensure the machine and documentation have a valid CDSCO approval.

What Is the Step‑by‑Step Process for CDSCO Registration of MRI Machines?

Here we have listed the easy step-by-step procedure to apply for CDSCO registration of MRI machines:

• Classification Check – Confirm MRI machines are Class C (high‑risk) under Medical Device Rules, 2017.
• Appoint Indian Agent – Foreign firms must nominate an Indian Authorized Agent with a Power of Attorney.
• Compile Technical Dossier – Gather all device details: design, manufacturing process, risk analysis, and test reports.
• Apply for an Import License or Registration
  • Imported MRI: Submit Form MD‑14 (import license) and Form MD‑15 (registration)
  • Domestic MRI: Submit Form MD‑42 (registration for local sale)
• Submit Documents & Fees – Upload the dossier and pay the prescribed fee on the CDSCO portal.
• Clinical Evaluation (if required) – CDSCO may ask for Indian clinical data or performance evaluations.
• Evaluation by CDSCO – Experts review the technical dossier, labels, and test reports.
• Grant of Registration Certificate – On satisfaction, CDSCO issues a registration certificate valid for five years.

What Documents Are Required for MRI Machine Registration?

Here, we have mentioned some of the important documents required for MRI machine registration. 

• Covering Letter
• Form MD‑14/MD‑15 or MD‑42
• Free Sale Certificate (FSC)
• ISO 13485 Certificate
• Technical Dossier
• Test Reports (Safety & Performance)
• Label & IFU (Instructions for Use)
• Power of Attorney

How Long Does CDSCO Registration Take and What Are the Fees?

Timeline:

• Import License (MD‑14): ~2–3 months
• Device Registration (MD‑15/MD‑42): 4–6 months (may vary)
• Fee Structure (approximate):
• Application fee for Class C devices: ₹90,000
• Registration certificate fee: ₹4,500 per year

Note: Fees are subject to change; always check the latest CDSCO schedule.

What Common Challenges Are Faced During Registration?

• Incomplete Technical Dossier: Missing test reports or risk analyses.
• Labeling Errors: Non‑compliant labels or missing Indian language inserts.
• Delayed Clinical Data: Requirement for local performance data.
• Agent Authorization Issues: Improper Power of Attorney format.
• Portal Submission Errors: Digital upload mistakes on the CDSCO portal.

How Can ELT Corporate Help You with CDSCO Registration for MRI Machines?

ELT Corporate, as a leading regulatory consultancy, can guide you through every step of CDSCO registration for MRI machines in India:

Device Classification & Strategy: Determine the correct risk class and route.

• Dossier Preparation: Assemble technical, clinical, and quality documents.
• Form Filing: Complete and submit MD‑14, MD‑15, or MD‑42 forms accurately.
• Testing & Labelling Review: Ensure compliance with Indian standards.
• Agent Appointment: Draft and verify the Power of Attorney for importers.
• Portal Management: Upload files and track applications on the CDSCO portal.
• Query Handling: Respond to CDSCO clarifications swiftly.
• Post‑Approval Support: Manage renewals, modifications, and audits.