CDSCO License for Ophthalmic working-channel cannula
Medical Device Information
Intended Use
A rigid tube designed to create a channel through the sclera for internal ocular access during posterior segment ophthalmic surgery. It is typically made of plastic materials or high-grade stainless steel and enables the introduction of ophthalmic surgical instruments; it may also be used for irrigation (i.e., the infusion of fluids to maintain the interior pressure of the eye during surgery). This is a reusable device.
Understanding Ophthalmic Working-Channel Cannula and Its Regulatory Significance
The Ophthalmic Working-Channel Cannula is a specialized Class B medical device used in posterior segment ophthalmic surgeries. Designed as a rigid tube to create a channel through the sclera, it facilitates the introduction of surgical instruments and irrigation fluids to maintain intraocular pressure. Typically manufactured from high-grade stainless steel or durable plastic, this reusable device plays a critical role in delicate eye surgeries.
Given its invasive nature and direct application in ocular surgery, obtaining proper regulatory approval from the Central Drugs Standard Control Organization (CDSCO) is essential for legal manufacturing and marketing in India. Compliance ensures patient safety, market credibility, and smooth business operations.
CDSCO Regulatory Framework for Ophthalmic Working-Channel Cannula
The CDSCO classifies medical devices into four risk classes (A, B, C, D) based on their potential risk to patients. The Ophthalmic Working-Channel Cannula falls under Class B (low-moderate risk), as specified in the notification Fts No. 29/MiscJO3/2020-DC (187) dated 9.8.2021.
Class B devices require a manufacturing license known as the MD5 license, issued by the State Licensing Authority. Importers of this device will need the MD15 import license issued by CDSCO Central Licensing Authority.
Risk Classification and License Requirements for This Device
- Risk Class: B
- License Type (Manufacturing): MD5 License (Form MD3)
- Issuing Authority: State Licensing Authority
- Timeline: Approximately 3-4 months
- Process: Includes test license (Form MD13), product testing at government-approved labs, audit by notified body, and final license grant.
For detailed classification criteria and risk management, review our Medical Device Classification guide and Risk Management best practices.
Manufacturing License Process (MD5) for Ophthalmic Working-Channel Cannula
Apply for Test License (Form MD13): This preliminary license allows you to conduct product testing. It typically takes 1.5 to 2 months for approval.
Product Testing: Conduct mandatory testing at any of the government-approved testing laboratories. Refer to the list of CDSCO-approved testing labs.
Document Preparation: Compile all necessary documentation including Device Master File, Plant Master File, risk management, and quality management system documents.
Submit MD5 License Application (Form MD3): File your manufacturing license application through the CDSCO MD Online Portal.
Audit by Notified Body: A mandatory audit is conducted by a notified body to verify compliance. Check the list of notified bodies.
Query Resolution: Address any queries or observations raised by CDSCO or the notified body promptly.
Grant of MD5 License: Upon successful compliance and audit clearance, the license is granted.
For a comprehensive walkthrough, see our detailed MD5 License guide.
Manufacturing License Documents Required
To avoid delays, manufacturers should prepare the following documents meticulously:
- Company Constitution and Incorporation Certificate
- Proof of Ownership or Lease Agreement of Manufacturing Premises
- Details and Qualifications of Technical Staff
- Fire NOC and Pollution Control Board NOC
- Device Master File (DMF) detailing design, specifications, and manufacturing process (Device Master File guide)
- Plant Master File (PMF) describing manufacturing facilities and quality systems (Plant Master File guide)
- Essential Principles Checklist confirming compliance to Indian medical device standards
- Risk Management File documenting hazard analysis and mitigation
- Product Test Reports from government-approved labs
- Product Labels and Instructions for Use (IFU)
- Quality Management System (QMS) Documentation, preferably ISO 13485:2016 certified
Import License Process (MD15) for Ophthalmic Working-Channel Cannula
If you are an importer of this device, obtaining the MD15 import license is essential. The process is as follows:
Document Compilation: Prepare all necessary documents including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016, CE Certificate (if applicable), DMF, PMF, wholesale license, and company constitution.
Application Submission: Submit the application on the CDSCO MD Online Portal.
Review and Queries: The Central Licensing Authority reviews the application and raises queries if needed.
License Grant: Upon satisfactory compliance, the MD15 license is issued.
The entire import license process takes about 5-6 months. For further details, consult our Import License guide.
Timeline and Processing Duration
| Stage | Duration |
|---|---|
| Test License (Form MD13) | 1.5 – 2 months |
| Product Testing | 1 – 1.5 months |
| Document Preparation | 2 – 4 weeks |
| MD5 License Application | 1 month |
| Audit and Query Resolution | 3 – 4 weeks |
| Total Manufacturing | 3 – 4 months |
Import license process averages 5-6 months.
Government Fees and Costs
MD5 Manufacturing License:
- Application Fee: Rs. 5,000
- Per Product Fee: Rs. 500
Test License (MD13): Nominal fees as per CDSCO norms
Import License (MD15):
- Class B devices: Approximately 1,000 per product
Note: Fees are subject to revision by CDSCO; always verify on the official portal.
Common Challenges and Practical Solutions
- Delayed Testing Reports: Plan testing in advance and select accredited government labs early to avoid bottlenecks.
- Incomplete Documentation: Use standardized templates for Device and Plant Master Files, and keep QMS documents ready.
- Audit Non-Compliance: Conduct internal mock audits using the notified body checklist to prepare for CDSCO audits.
- Query Handling Delays: Respond promptly with clear, evidence-backed explanations to minimize processing time.
Expert Consultation and Support
With over 25 years of experience assisting 500+ companies, we specialize in streamlining CDSCO licensing for ophthalmic devices. Our end-to-end support includes document preparation, audit readiness, and liaison with regulatory authorities to ensure timely approvals.
Getting Started with Your CDSCO License Application
- Assess your device classification to confirm MD5 license eligibility.
- Register your firm and key personnel on the CDSCO MD Online Portal.
- Initiate the test license application (Form MD13) and concurrently prepare your product for testing.
- Engage with a notified body early to schedule audits.
- Compile your documentation using our Device Master File and Plant Master File guides.
- Submit the MD5 application (Form MD3) once test reports and audit readiness are confirmed.
Taking these proactive steps can significantly reduce your application processing time and help you bring your ophthalmic working-channel cannula to the Indian market efficiently.
For personalized assistance and to navigate regulatory complexities with confidence, connect with our experts today.
