CDSCO License for Lacrimal tube
Medical Device Information
Intended Use
A implantable, single-lumen tube intended to provide tear drainage from the front surface of the eye, and also to facilitate saline solution irrigation to a paranasal sinus to manage chronic rhinosinusitis.
Introduction to Lacrimal Tube and Regulatory Importance
Lacrimal tubes are critical ophthalmic devices designed as implantable, single-lumen tubes that facilitate tear drainage from the eye's front surface and allow saline irrigation to paranasal sinuses, particularly for managing chronic rhinosinusitis. Given their implantable nature and significant clinical impact, lacrimal tubes fall under Class C medical devices in India, signifying a moderate to high risk that demands stringent regulatory compliance.
Navigating the Central Drugs Standard Control Organization (CDSCO) regulatory framework for such devices is imperative for manufacturers and importers aiming to enter the Indian market. Proper licensing ensures patient safety, market credibility, and legal adherence, helping avoid costly delays or rejections.
CDSCO Regulatory Framework for Lacrimal Tubes (Class C)
Lacrimal tubes are regulated under the Ministry of Health and Family Welfare’s CDSCO guidelines, specifically categorized under Class C in the ophthalmology device segment, as notified in Fts No. 29/MiscJO3/2020-DC (187) dated 9.8.2021.
For Class C devices like lacrimal tubes, the CDSCO mandates obtaining a centralized manufacturing license (MD9) and an import license (MD15) if the product is to be imported. Both processes involve rigorous testing, documentation, and audits to ensure compliance with the Medical Device Rules, 2017.
Risk Classification and License Requirements for Lacrimal Tubes
Being a Class C device, lacrimal tubes require:
- MD9 Manufacturing License: Approved by CDSCO Central Licensing Authority, mandatory for domestic manufacturers.
- MD15 Import License: Required for importers to legally market lacrimal tubes in India.
Class C devices undergo a more stringent verification process due to their medium-high risk profile, focusing on safety, efficacy, and quality management.
Manufacturing License Process for Lacrimal Tubes (MD9)
The manufacturing license process for lacrimal tubes involves several distinct stages:
Test License Application (Form MD13): Manufacturers must first secure a test license, which takes approximately 1.5 to 2 months. This allows the device to be tested in government-approved laboratories.
Product Testing: Conduct testing at CDSCO-recognized labs (Testing Laboratories) to validate safety and performance.
Documentation Preparation: Compile extensive documentation including Device Master File (DMF), Plant Master File (PMF), risk management files, and quality system records.
License Application Submission (Form MD7): Submit the MD9 application through the CDSCO MD Online Portal after testing and documentation are ready.
Inspection and Audit: CDSCO officials perform a detailed audit verifying compliance with regulatory norms.
Query Resolution: Address any observations or queries raised by the inspectors or CDSCO.
License Grant (Form MD9): Upon satisfactory compliance, the manufacturing license is granted.
The entire process typically spans 4 to 5 months.
Manufacturing License Documents Required for Lacrimal Tubes
For MD9 license applications, the following documents are essential:
- Company Constitution documents (e.g., Certificate of Incorporation)
- Proof of ownership or tenancy of manufacturing premises
- Details and qualifications of technical staff
- Fire and Pollution NOCs
- Device Master File (DMF) – detailing design, manufacturing process, and quality controls (refer to our comprehensive Device Master File Guide)
- Plant Master File (PMF) – detailing manufacturing facility and equipment (see our Plant Master File Guide)
- Essential Principles Checklist as per Medical Device Rules
- Risk Management File implementing ISO 14971 principles (Risk Management Guide)
- Test Reports from government-approved labs
- Product labels and Instructions for Use (IFU)
- Quality Management System (QMS) documentation, typically ISO 13485:2016 compliant
Import License Process for Lacrimal Tubes (MD15)
For companies importing lacrimal tubes into India, obtaining an MD15 license is mandatory. The import license process includes:
Document Preparation: Assemble all regulatory and quality documentation, including manufacturing license from the country of origin, Free Sale Certificate, and CE certification.
Application Submission (Form MD14): Submit the application through the CDSCO MD Online Portal.
Departmental Review and Queries: Respond promptly to any queries or requests for additional information.
License Issuance (Form MD15): After successful review, CDSCO grants the import license.
This process generally takes around 5 to 6 months.
Import License Documents Required for Lacrimal Tubes
Key documents required include:
- Valid manufacturing license from the exporting country
- Free Sale Certificate (FSC) or Certificate of Market Authorization
- ISO 13485:2016 certification for QMS
- CE Certificate, if applicable
- Device Master File and Plant Master File
- Wholesale Drug License or equivalent local distributor license
- Company Constitution and registration documents
Timeline and Processing Duration
| License Type | Typical Timeline |
|---|---|
| Test License (MD13) | 1.5 - 2 months |
| Manufacturing License (MD9) | 4 - 5 months total (including test license and audit) |
| Import License (MD15) | 5 - 6 months |
Planning timelines realistically is critical to avoid market entry delays.
Government Fees and Costs
| License Type | Fee Details |
|---|---|
| MD9 Manufacturing License | ₹50,000 per application + ₹1,000 per product |
| MD15 Import License | 1,500 per product (approximate, subject to exchange rate) |
Additional costs include laboratory testing fees, notified body audits, and documentation preparation.
Common Challenges and Solutions
- Delay in Testing and Audit: Government-approved labs can have backlog; engage early and consider pre-assessment audits.
- Incomplete Documentation: Use detailed checklists and professional guidance to ensure all documents like DMF, PMF, and Risk Management files meet standards.
- Query Resolution Delays: Prepare to respond quickly and comprehensively to CDSCO queries to avoid prolonged processing.
- Understanding QMS Requirements: Align with ISO 13485:2016 and maintain robust internal processes.
Our experience with over 500 companies shows that proactive planning and expert consultation mitigate these challenges effectively.
Expert Consultation and Support
Navigating CDSCO regulations for Class C devices like lacrimal tubes demands expertise. Our consultancy offers:
- End-to-end license application support
- Comprehensive document preparation services
- Liaison with testing laboratories and notified bodies (Notified Bodies List)
- Post-approval compliance assistance
Partnering with experienced consultants significantly reduces the risk of rejections and accelerates time-to-market.
Getting Started with Your CDSCO License Application
To initiate your lacrimal tube licensing process:
- Classify your device accurately and confirm risk class C as per the Medical Device Classification.
- Register on the CDSCO MD Online Portal and familiarize yourself with the application forms MD7 (manufacturing) and MD14 (import).
- Arrange initial testing and prepare your Device and Plant Master Files.
- Consult with notified bodies early to schedule audits and inspections.
- Assemble your quality management documentation aligning with ISO 13485 and risk management standards.
- Submit your test license application (MD13) promptly to initiate the process.
Starting early and methodically can save months of processing time and ensure a smooth regulatory journey.
For detailed guidance and personalized support, feel free to reach out to our regulatory experts who have successfully guided 500+ companies in obtaining CDSCO licenses for ophthalmic and other medical devices.
