CDSCO License for Diagnostic x-ray tube housing assembly.
Medical Device Information
Important Notice for Class A Devices
Class A Non-sterile Non Measuring devices are exempt from MD5 and MD15 licenses. Only CDSCO registration is required as per GSR 777(E).
Intended Use
A diagnostic x-ray tube housing assembly is an x-ray generating tube encased in a radiation-shielded housing that is intended for diagnostic purposes.

Comprehensive Guide to CDSCO Licensing for Diagnostic X-ray Tube Housing Assembly (Class A)
As seasoned regulatory consultants with over 25 years of experience and a track record of assisting 500+ companies, we understand the complexities manufacturers and importers face when seeking CDSCO licenses for medical devices. The Diagnostic X-ray Tube Housing Assembly is a critical component in interventional radiology, classified under Risk Class A due to its intended diagnostic use and radiation shielding features. Ensuring compliance with CDSCO regulations is paramount to accessing the Indian market.
Understanding the Diagnostic X-ray Tube Housing Assembly and Its Regulatory Importance
A Diagnostic X-ray Tube Housing Assembly is essentially an x-ray generating tube enclosed within a radiation-shielded casing. This device plays a pivotal role in diagnostic imaging by safely containing and directing x-rays. Given its function and potential radiation exposure, regulatory oversight by the Central Drugs Standard Control Organization (CDSCO) ensures safety, efficacy, and quality.
The notification governing this device is 29/Misc./03/2020-DC (146) dated 26.07.2021, which places it firmly in the scope of CDSCO’s medical devices regulations.
CDSCO Regulatory Framework for Diagnostic X-ray Tube Housing Assembly
As a Risk Class A device, the Diagnostic X-ray Tube Housing Assembly falls under the lowest risk category but still requires a thorough regulatory process. The license applicable here is the MD5 license, granted by the State Licensing Authority. This license is mandatory for manufacturing within India.
The CDSCO regulatory framework mandates adherence to quality management systems, product testing, technical documentation, and compliance with essential principles to ensure device safety and performance.
Risk Classification and License Requirements
- Risk Class: A (Low risk)
- License Type: MD5 License (Manufacturing License) using Application Form MD3
- Regulatory Authority: State Licensing Authority
- Timeline: Approx. 3-4 months for the entire process
- Fees: Rs 5000 per application + Rs 500 per product
To confirm the risk classification of your device, you can refer to our detailed Medical Device Classification guide.
Manufacturing License Process (MD5) for Diagnostic X-ray Tube Housing Assembly
The manufacturing license process involves several key steps:
Test License Application (Form MD13): Before applying for the MD5 license, manufacturers must obtain a test license, which takes about 1.5 to 2 months. This allows the device to be tested at government-approved labs.
Product Testing: Testing must be conducted at CDSCO-recognized labs. You can check the list of approved Testing Laboratories here.
Documentation Preparation: Compile all necessary documents including Device Master File, Plant Master File, Risk Management File, and more.
Application Submission: Submit the MD5 application via the CDSCO MD Online Portal.
Audit by Notified Body: An audit is conducted by a notified body listed in the official Notified Bodies List.
Query Resolution: Address any queries raised by the department or the notified body promptly.
License Grant: Upon satisfactory completion, the MD5 license is granted.
Manufacturing License Documents Required for MD5
For your Diagnostic X-ray Tube Housing Assembly, the following documents are essential:
- Company Constitution Documents: Including Memorandum and Articles of Association.
- Proof of Ownership or Lease of Manufacturing Premises: Valid legal documents.
- Technical Staff Documents: Qualification certificates and experience proofs of responsible personnel.
- Fire NOC and Pollution Control NOC: From relevant local authorities.
- Device Master File (DMF): Detailed technical specifications and design data. Refer to our Device Master File guide for preparation tips.
- Plant Master File (PMF): Manufacturing processes, quality control measures, and facility details. Learn more from our Plant Master File guide.
- Essential Principles Checklist: Compliance matrix with CDSCO’s essential principles.
- Risk Management File: Evidence of risk analysis and mitigation strategies. See our Risk Management guide for details.
- Test Reports: From government-approved testing laboratories.
- Labels and Instructions for Use (IFU): Drafts that comply with CDSCO labeling requirements.
- Quality Management System (QMS) Documents: ISO 13485 certification and related system procedures.
Import License Process (MD15) for Diagnostic X-ray Tube Housing Assembly
If you are looking to import the Diagnostic X-ray Tube Housing Assembly instead of manufacturing it locally, the import license under Form MD14 (leading to MD15 license grant) is required.
- Regulatory Authority: Central Licensing Authority (CDSCO HQ)
- Timeline: Approximately 5-6 months
- Fees: Varies by device class; for Class A devices, typically 50 per product
The process involves document preparation, submission via the CDSCO MD Online Portal, queries resolution, and license issuance. Required documents include Manufacturing License, Free Sale Certificate, ISO 13485, CE Certificate, Device and Plant Master Files, Wholesale License, and Company Constitution.
For detailed guidance, consult our Import License guide.
Timeline and Processing Duration
Step | Duration |
---|---|
Test License (MD13) | 1.5 - 2 months |
Product Testing | 1 - 1.5 months |
Document Preparation | 2 - 3 weeks |
Application Submission | Immediate upon readiness |
Notified Body Audit | 3 - 4 weeks |
Query Resolution | 2 - 3 weeks |
License Grant (MD5) | 1 week |
Total: Approximately 3-4 months from start to finish.
Government Fees and Costs
- Test License (MD13): Included within application fees.
- MD5 License Application Fee: Rs 5000 per application
- Product Fee: Rs 500 per product
- Audit Fees: Typically borne by the applicant and varies by notified body; budget INR 50,000 to 1,00,000 depending on scope.
Budgeting accurately for these costs helps avoid unexpected delays.
Common Challenges and Solutions
- Delayed Testing: Testing labs often have backlogs; early booking is essential.
- Incomplete Documentation: Missing or inconsistent documents can stall approval. Use detailed checklists aligned with CDSCO requirements.
- Audit Non-compliance: Prepare your facility and QMS thoroughly. Engage with notified bodies early for pre-audit consultations.
- Query Resolution Delays: Assign a dedicated regulatory liaison to respond promptly and comprehensively.
We recommend leveraging our expertise to navigate these hurdles efficiently.
Expert Consultation and Support
Our team has supported over 500 companies in securing CDSCO licenses for Class A devices like the Diagnostic X-ray Tube Housing Assembly. From document preparation to audit readiness and liaison with CDSCO officials, we provide end-to-end support tailored to your product’s unique needs.
Getting Started with Your CDSCO License Application
- Assess Device Classification: Confirm your device is Class A via CDSCO guidelines.
- Prepare Test License Application (MD13): Begin compiling necessary documents and schedule testing.
- Book Testing with Approved Labs: Early scheduling reduces overall timeline risks.
- Develop Comprehensive Documentation: Utilize our Device Master File and Plant Master File guides.
- Submit Application via CDSCO MD Online Portal: Register and track your application at the CDSCO MD Online Portal.
- Prepare for Notified Body Audit: Coordinate with a notified body from the official Notified Bodies List.
- Address Queries Promptly: Assign a point person to handle communications.
Taking these practical steps will position your Diagnostic X-ray Tube Housing Assembly for timely approval and market entry. Contact us to leverage our consultancy expertise and accelerate your regulatory journey.