CDSCO License for Colorectal sizer

Comprehensive Guide to CDSCO Licensing for Colorectal Sizer (Class B Medical Device)

As seasoned regulatory consultants with over 25 years of industry experience and having supported 500+ companies in successfully obtaining CDSCO licenses, we understand the nuances of bringing specialized medical devices like the Colorectal Sizer to the Indian market. This hand-held, manual surgical instrument designed to measure colon and rectal lumen diameter plays a critical role in gastroenterology, aiding surgeons in selecting the optimal intraluminal stapler size for bowel anastomosis. Given its classification as a Class B device under the CDSCO framework, specific regulatory pathways and documentation are required to ensure compliance and timely market access.

CDSCO Regulatory Framework for Colorectal Sizers

The Colorectal Sizer falls under the gastroenterology category and is regulated in accordance with the CDSCO notification 29/Misc./03/2020-DC (182) dated 27.09.2021. As a Class B medical device, it is subject to a moderate risk classification, necessitating a manufacturing license under the MD5 category granted by the State Licensing Authority.

Risk Classification and License Requirements

According to the CDSCO medical device classification, Class B includes devices with low to moderate risk. The Colorectal Sizer’s intended use in surgical settings makes it essential to comply with the MD5 licensing process. This entails obtaining a test license, conducting product testing in government-approved laboratories, undergoing a notified body audit, and finally securing the manufacturing license.

For a detailed understanding of device classification, manufacturers can refer to the Medical Device Classification guide.

Manufacturing License Process (MD5)

The MD5 license process for Class B devices like the Colorectal Sizer is managed by the respective State Licensing Authority and typically spans 3 to 4 months. Here’s a step-by-step breakdown:

1. Test License on Form MD13: Initially, the manufacturer must apply for a test license (MD13) through the CDSCO MD Online Portal. This stage takes approximately 1.5 to 2 months and permits limited manufacture for testing.

2. Product Testing: The device must undergo testing at government-approved labs listed on the CDSCO portal to validate safety and performance.

3. Document Preparation: Comprehensive documentation including quality management system (QMS) files, Device Master File (DMF), Plant Master File (PMF), risk management files, and essential principles checklist are compiled.

4. Application Submission: The manufacturing license application is submitted on Form MD3 for MD5 licensing.

5. Audit by Notified Body: An audit is conducted by a notified body listed on the Notified Bodies List. This evaluation examines compliance with QMS and regulatory requirements.

6. Query Resolution: Any queries from the licensing authority or notified body must be addressed promptly.

7. Grant of License: Upon satisfactory review, the license is granted on Form MD5.

For comprehensive guidance, consult our MD5 License Guide.

Manufacturing License Documents Required

To ensure a smooth application process, manufacturers should prepare the following documents meticulously:

• Certificate of Incorporation/Company Constitution
• Proof of ownership or lease of manufacturing premises
• Details and qualifications of technical staff
• Fire and Pollution NOCs
• Device Master File (DMF) detailing design, manufacturing process, and specifications (Device Master File Guide)
• Plant Master File (PMF) covering manufacturing facilities and processes (Plant Master File Guide)
• Essential Principles Checklist confirming product compliance
• Risk Management File documenting hazard analysis and mitigation (Risk Management)
• Test Reports from CDSCO-approved testing laboratories (Testing Laboratories)
• Device labels and Instructions for Use (IFU)
• Quality Management System (QMS) documents, preferably ISO 13485:2016 certification

Import License Process (MD15)

If you are an importer of the Colorectal Sizer, obtaining an MD15 import license from the Central Licensing Authority is mandatory. The process generally takes 5 to 6 months and involves:

• Preparation of documents including manufacturing license, Free Sale Certificate from the country of origin, ISO 13485:2016, CE Certificate, DMF, PMF, wholesale license, and company constitution
• Application submission on Form MD14 via the CDSCO MD Online Portal
• Resolution of queries raised by the department
• Grant of MD15 import license

For detailed procedures, see our Import License Guide.

Import License Documents Required

Key documents for the import license include:

• Valid manufacturing license for the Colorectal Sizer
• Free Sale Certificate or equivalent from the country of origin
• ISO 13485:2016 certificate
• CE Certificate or other international conformity certificates
• Device Master File and Plant Master File
• Wholesale Drug License
• Company Constitution or Certificate of Incorporation

Timeline and Processing Duration

Total: Approximately 3 to 4 months for the complete manufacturing license process.

Government Fees and Costs

• MD5 Manufacturing License: Rs 5,000 per application + Rs 500 per product
• Test License (MD13): No separate fee but included in the overall process

These fees cover application processing, audit, and issuance of the license.

Common Challenges and Solutions

Challenge: Delays in product testing due to limited slots at government-approved labs.

Solution: Schedule testing appointments early and consider labs with shorter turnaround times listed on the Testing Laboratories portal.

Challenge: Incomplete or inconsistent documentation leading to queries and rejections.

Solution: Engage expert regulatory consultants to prepare and cross-verify all documents; utilize templates and checklists from our guides to ensure completeness.

Challenge: Audit non-compliance due to inadequate QMS implementation.

Solution: Implement ISO 13485:2016 standards and conduct internal audits before notified body inspections.

Expert Consultation and Support

Navigating the CDSCO licensing landscape can be complex, especially for specialized devices like the Colorectal Sizer. Our team offers end-to-end support—from initial classification and documentation preparation to audit facilitation and query resolution. Leveraging our experience with 500+ successful applications, we streamline your licensing journey and minimize regulatory risks.

Getting Started with Your CDSCO License Application

1. Assess Device Classification: Confirm your Colorectal Sizer as Class B using official CDSCO resources.
2. Initiate Test License Application: Register and apply through the CDSCO MD Online Portal.
3. Plan Product Testing: Schedule testing with government-approved labs early to avoid bottlenecks.
4. Prepare Documentation: Utilize our detailed guides to compile comprehensive DMF, PMF, risk management, and QMS documents.
5. Engage a Notified Body: Choose an accredited notified body from the Notified Bodies List for your audit.
6. Submit Manufacturing License Application: File Form MD3 once testing and audit are satisfactorily completed.
7. Respond Promptly to Queries: Maintain communication channels open for quick resolution of any regulatory questions.

Embarking on this structured approach ensures your Colorectal Sizer meets all regulatory mandates, enabling confident entry into the Indian healthcare market. For personalized assistance, feel free to contact our expert team.