CDSCO License for Colonic cytology sampling set
Medical Device Information
Intended Use
A collection of non-sterile devices intended to collect exfoliated colonic cells (colonocytes) from the surface of human rectal mucosa for colorectal cancer investigation and/or patient screening.
Comprehensive Guide to CDSCO Licensing for Colonic Cytology Sampling Set (Class B Medical Device)
Entering the Indian medical device market with your Colonic Cytology Sampling Set requires meticulous adherence to the Central Drugs Standard Control Organization (CDSCO) regulatory framework. This device, designed to collect exfoliated colonocytes from the rectal mucosa for colorectal cancer screening, falls under Risk Class B due to its moderate risk profile in oncology diagnostics. With over 25 years of experience and having assisted 500+ companies, we provide you with a detailed, practical roadmap to secure your CDSCO manufacturing or import license efficiently.
Understanding the CDSCO Regulatory Framework for Class B Devices
The CDSCO classifies medical devices into four risk categories—Class A (low risk), Class B (low moderate risk), Class C (moderate high risk), and Class D (high risk). Your Colonic Cytology Sampling Set is categorized as Class B, meaning it requires a State Licensing Authority-issued manufacturing license (MD5) and a stringent compliance process to ensure patient safety and product efficacy.
The official notification for this device is File No. 29/Misc./03/2020-DC (153) — Part 1, dated 11.10.2022, confirming its regulated status under the medical devices rules.
Risk Classification and License Requirements for Colonic Cytology Sampling Set
- Risk Class: B (Low Moderate Risk)
- License Required: Manufacturing License MD5 (Application Form MD3) for manufacturers
- Regulatory Authority: State Licensing Authority
- License for Import: MD15 (Central Licensing Authority) if importing
Manufacturing License Process for Class B Devices (MD5 License)
The pathway for obtaining an MD5 license involves several critical steps:
Test License (Form MD13): Initiate with a test license application, which typically takes 1.5 to 2 months. This allows product testing and validation.
Product Testing: Conduct testing at CDSCO-approved laboratories to ensure compliance with Indian standards. Refer to the list of testing laboratories for authorized centers.
Document Preparation: Compile comprehensive technical documentation including Device Master File and Plant Master File.
License Application (Form MD3): Submit your manufacturing license application through the CDSCO MD Online Portal.
Audit by Notified Body: A mandatory audit by an accredited notified body to assess your facility and quality management system. You can check the notified bodies list here.
Query Resolution: Address any queries from the licensing authority or notified body promptly.
Grant of License: Once all requirements are met, the license is granted on Form MD5.
Manufacturing License Documents Required
For your Colonic Cytology Sampling Set, ensure the following documents are meticulously prepared:
- Company Constitution (e.g., MOA, AOA)
- Proof of ownership or lease agreement for manufacturing premises
- Qualification and experience certificates for technical staff
- Fire NOC and Pollution Control Board NOC
- Device Master File (DMF): Detailed device specifications, manufacturing process, and design controls. Our Device Master File guide can help streamline this.
- Plant Master File (PMF): Comprehensive overview of your manufacturing facility. Learn more from our Plant Master File guide.
- Essential Principles Checklist demonstrating compliance with safety and performance requirements
- Risk Management File addressing potential hazards, mitigation, and clinical evaluation. Refer to our Risk Management implementation guide.
- Test Reports from CDSCO-approved laboratories
- Sample Labels and Instructions for Use (IFU)
- Quality Management System (QMS) documentation, preferably ISO 13485:2016 certified
Import License Process for Colonic Cytology Sampling Set (MD15 License)
If you are importing this Class B device, the MD15 import license is mandatory. The process includes:
Document Compilation: Prepare all required documents including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016 certification, CE Certificate, Device and Plant Master Files, wholesale license, and company constitution.
Application Submission: Apply via the CDSCO MD Online Portal using Form MD14.
Query Resolution: Promptly respond to any departmental queries.
License Grant: The central licensing authority issues the MD15 license.
Import License Documents Required
- Valid Manufacturing License of the foreign manufacturer
- Free Sale Certificate or Certificate of Marketability
- ISO 13485:2016 Certification
- CE Marking Certificate (if applicable)
- Device Master File and Plant Master File
- Wholesale License (if applicable)
- Company Constitution documents
- Detailed product description and labeling
Timeline and Processing Duration
| License Type | Process Duration | Key Milestones |
|---|---|---|
| MD5 (Manufacturing, Class B) | 3-4 months | 1.5-2 months test license, lab testing, audit, documentation, license grant |
| MD15 (Import) | 5-6 months | Document preparation, application, queries, license grant |
Planning ahead for these timelines can prevent project delays. For example, initiating your test license application and lab testing simultaneously can save valuable time.
Government Fees and Costs
MD5 Manufacturing License:
- Application Fee: Rs 5,000 per application
- Per Product Fee: Rs 500
MD15 Import License:
- Class B Fee Structure: 1,000 per product (approximate INR conversion applies)
These fees are payable online at the time of application submission via the CDSCO portal.
Common Challenges and Practical Solutions
Delayed Test License Approval: Submit a complete application with all required documents upfront. Engage with notified bodies early for audit scheduling.
Inadequate Documentation: Utilize our detailed checklists and expert guidance to prepare your Device and Plant Master Files accurately.
Audit Non-compliance: Conduct a pre-audit internal assessment and implement a robust QMS aligned with ISO 13485 to ensure smooth audits.
Query Management Delays: Assign a dedicated regulatory liaison to respond to CDSCO queries promptly, minimizing approval timeline extensions.
Expert Consultation and Support
Navigating CDSCO’s regulatory landscape requires expertise and strategic planning. Our team, with 25+ years of regulatory consulting and over 500 successful licensing projects, offers tailored support—from document preparation to audit facilitation and query resolution—to streamline your licensing journey.
Getting Started with Your CDSCO License Application
Assess Your Product Classification: Confirm your device’s classification as Class B using resources like the Medical Device Classification guide.
Register on CDSCO MD Online Portal: Create your account at the CDSCO MD Online Portal and familiarize yourself with the application workflow.
Initiate Test License Application (MD13): Prepare and submit your test license application to begin product testing.
Engage a Notified Body Early: Select an accredited notified body from the official list to schedule your audit.
Prepare Comprehensive Documentation: Leverage our guides on Device Master Files and Plant Master Files to build a robust technical dossier.
Plan for Timelines and Fees: Budget for the fees and anticipate the 3-4 month timeline for MD5 license acquisition.
By following these actionable steps and partnering with experienced consultants, manufacturers and importers can significantly reduce regulatory risks and achieve timely market access for their Colonic Cytology Sampling Set in India.
For detailed assistance or to discuss your specific requirements, contact us today and let our regulatory experts guide you toward CDSCO compliance success.
