CDSCO License for Rectoscope/proctoscope handle

Comprehensive Guide to CDSCO Licensing for Rectoscope/Proctoscope Handle (Class A Medical Device)

As seasoned regulatory consultants with over 25 years of experience and having supported 500+ companies in navigating CDSCO licensing, we understand the specific nuances of obtaining approval for Class A medical devices like the Rectoscope/proctoscope handle. This manual device, intended as a handle to hold rectoscopes or proctoscopes during gastrointestinal examination procedures, falls under the low-risk Class A category as per the CDSCO notification 29/Misc./03/2020-DC (182) dated 27.09.2021.

Securing the appropriate CDSCO license is critical for legally manufacturing and marketing this device in India. Below, we provide a detailed, practical roadmap covering timelines, costs, document requirements, and common challenges to help manufacturers and importers achieve seamless regulatory compliance.

CDSCO Regulatory Framework for Rectoscope/Proctoscope Handle

The Central Drugs Standard Control Organization (CDSCO) governs the regulation of medical devices in India. The Rectoscope/proctoscope handle is classified as a Class A device under the Medical Device Rules due to its minimal risk profile. Compliance with these rules ensures patient safety and market authorization.

This device category is regulated by the State Licensing Authority, which issues the MD5 manufacturing license (application form MD3).

Risk Classification and License Requirements

Device: Rectoscope/proctoscope handle
Risk Class: A (Low risk)
Regulatory Pathway: MD5 Manufacturing License
Authority: State Licensing Authority
Applicable Rule: Medical Device Rules 2017, as amended by Notification 29/Misc./03/2020-DC (182)

You can verify your device’s classification on the Medical Device Classification guide.

Manufacturing License Process (MD5)

The MD5 license process for Class A devices involves several critical steps:

Test License Application (Form MD13): Before applying for the MD5 license, manufacturers must obtain a test license for 1.5 to 2 months. This allows initial product testing and evaluation.
Product Testing: Conduct tests at CDSCO-approved laboratories to validate device safety and performance. Refer to the list of testing laboratories.
Document Preparation: Compile all required documents, including technical files, quality management system (QMS) records, and risk management files.
Application Submission (Form MD3): Submit the MD5 license application through the CDSCO MD Online Portal.
Audit by Notified Body: An audit is conducted by a notified body from the CDSCO list (Notified Bodies List) to verify compliance.
Query Resolution: Address any queries raised by the authority or the notified body promptly.
License Grant (Form MD5): Upon successful audit and documentation review, the State Licensing Authority issues the MD5 manufacturing license.

For a detailed understanding of the MD5 licensing process, our MD5 License Guide provides step-by-step insights.

Manufacturing License Documents Required

To facilitate a smooth application, ensure you have the following documents ready:

Company Constitution: Certificate of incorporation, partnership deed, or LLP agreement.
Proof of Ownership or Lease of Manufacturing Premises: Legal documents confirming site control.
Technical Staff Details: Qualification and experience certificates of key personnel.
Fire NOC and Pollution Control NOC: Compliance certificates from local authorities.
Device Master File (DMF): Comprehensive documentation of device design and manufacturing processes. See our Device Master File Guide.
Plant Master File (PMF): Details on manufacturing facilities and quality control systems. Learn more in our Plant Master File Guide.
Essential Principles Checklist: Compliance with Medical Device Rules essential principles.
Risk Management File: Evidence of risk assessment and mitigation strategies. Refer to our Risk Management guide.
Test Reports: From CDSCO-approved labs confirming device safety and performance.
Labels and Instructions for Use (IFU): Device labeling and user manuals.
Quality Management System Documents: ISO 13485 certification and related policies.

Import License Process (MD15)

For importers of Class A devices like the Rectoscope/proctoscope handle, an MD15 import license must be obtained from the Central Licensing Authority. Though the focus here is manufacturing, it’s relevant for companies importing this device.

The process involves:

Document preparation including Free Sale Certificate, ISO 13485, CE Certificate, Device and Plant Master Files, and Wholesale License.
Application submission via Form MD14 on the CDSCO MD Online Portal.
Queries resolution.
License grant on Form MD15.

For detailed import guidelines, visit our Import License Guide.

Import License Documents Required

Valid Manufacturing License from the country of origin
Free Sale Certificate
ISO 13485:2016 Certification
CE Certificate (if applicable)
Device Master File and Plant Master File
Wholesale License
Company Constitution Documents

Timeline and Processing Duration

Step	Duration
Test License (MD13)	1.5 – 2 months
Product Testing	1 – 1.5 months
Document Preparation	Concurrent with Testing
MD5 License Application	Submission after test license
Notified Body Audit	2 – 4 weeks
Query Resolution	2 – 3 weeks
License Grant	Total 3 – 4 months from start

Planning for approximately 3 to 4 months ensures realistic expectations and resource allocation.

Government Fees and Costs

Test License (MD13): Included in MD5 process, nominal fees apply.
MD5 License Application Fee: Rs 5,000 per application
Product Fee: Rs 500 per product (Rectoscope/proctoscope handle)
Notified Body Audit Fees: Varies by body; typically Rs 20,000 – Rs 50,000

Budgeting for these fees upfront avoids delays. Note that audit fees are payable directly to the notified body.

Common Challenges and Solutions

Challenge 1: Incomplete Documentation

Solution: Use detailed checklists and expert templates for Device and Plant Master Files to ensure completeness.

Challenge 2: Delays in Product Testing

Solution: Engage with CDSCO-approved laboratories early and schedule testing slots in advance.

Challenge 3: Audit Non-compliance

Solution: Conduct pre-audit internal assessments and remedial training for staff.

Challenge 4: Query Resolution Delays

Solution: Assign a dedicated regulatory affairs specialist to respond promptly and accurately.

Expert Consultation and Support

Navigating the CDSCO licensing landscape can be complex, especially for first-time manufacturers. Our experience with over 500 successful licenses positions us uniquely to guide you through:

Preparing customized documentation
Liaising with notified bodies and CDSCO authorities
Managing timelines efficiently
Ensuring compliance with evolving regulations

Leveraging expert consultation significantly increases your chances of swift license approval.

Getting Started with Your CDSCO License Application

Assess Device Classification: Confirm Class A status using the official CDSCO guidelines.
Register on CDSCO MD Online Portal: Create your account at the CDSCO MD Online Portal.
Initiate Test License Application: Submit Form MD13 to begin product testing.
Schedule Product Testing: Coordinate with CDSCO-approved labs early.
Prepare Documents: Use our Device and Plant Master File guides to compile comprehensive files.
Plan for Audit: Identify and engage a notified body from the Notified Bodies List.
Submit MD5 Application: Once testing is complete, submit Form MD3.
Respond to Queries: Monitor application status regularly and respond promptly.

By following these pragmatic steps, manufacturers and importers can confidently enter the Indian market with their Rectoscope/proctoscope handle under full regulatory compliance.

For personalized assistance and end-to-end support, connect with our regulatory team to streamline your CDSCO licensing journey.

CDSCO License for Rectoscope/proctoscope handle

Medical Device Information

Important Notice for Class A Devices

Intended Use