CDSCO License for Contact lens disinfecting solution
Medical Device Information
Intended Use
An aqueous formulation containing appropriate agents for loosening debris from contact lenses, and that contains a disinfectant intended to act on contact lens.
Comprehensive Guide to CDSCO Licensing for Contact Lens Disinfecting Solution (Class B Medical Device)
Contact lens disinfecting solutions play a critical role in ophthalmology by ensuring the safe and effective disinfection of contact lenses, thereby preventing eye infections and maintaining ocular health. Given their direct application in the eye, regulatory compliance is paramount to guarantee product safety and efficacy for Indian consumers. With over 25 years of experience and having assisted 500+ companies in CDSCO licensing, we provide you with an expert roadmap to navigate the regulatory landscape successfully.
CDSCO Regulatory Framework for Contact Lens Disinfecting Solutions
The Central Drugs Standard Control Organization (CDSCO) governs the import, manufacture, and sale of medical devices in India. Contact lens disinfecting solutions fall under the ophthalmology category and are classified as Class B devices, which represent a low to moderate risk level. These devices are regulated under the Medical Device Rules (MDR) 2017 notified by the Government of India, specifically referenced under the notification Fts No. 29/MiscJO3/2020-DC (187) dated 9.8.2021.
Risk Classification and License Requirements for Contact Lens Disinfecting Solutions
According to CDSCO's risk-based classification system, contact lens disinfecting solutions are Class B devices. This classification mandates obtaining a Manufacturing License MD5 issued by the State Licensing Authority for domestic manufacturing. For importers, the Import License MD15 issued by the Central Licensing Authority is applicable.
Manufacturing License Process for Class B Devices (MD5)
Manufacturing contact lens disinfecting solutions in India requires obtaining the MD5 license, which involves a multi-step process:
- Test License Application (Form MD13): Initially, apply for a test license to manufacture and test the product for compliance. This stage takes approximately 1.5 to 2 months.
- Product Testing: Conduct mandatory product testing through CDSCO-approved government laboratories. You can refer to the list of testing laboratories approved by CDSCO for validated testing.
- Preparation of Documentation: Prepare comprehensive technical documentation including Device Master File, Plant Master File, Risk Management File, and Essential Principles Checklist.
- Application for MD5 License (Form MD3): Submit the manufacturing license application through the CDSCO MD Online Portal.
- Audit by Notified Body: Undergo an audit by a CDSCO notified body. Check the list of notified bodies for an authorized auditor.
- Resolution of Queries: Address any issues or queries raised by the licensing authority or notified body.
- Grant of Manufacturing License (Form MD5): Upon successful compliance, the license is granted.
Manufacturing License Documents Required
For contact lens disinfecting solutions under Class B, prepare the following documents meticulously:
- Company Constitution Documents (Incorporation Certificate, Memorandum & Articles of Association)
- Proof of Ownership or Lease of Manufacturing Premises
- Details and Qualification Certificates of Technical Staff
- Fire NOC and Pollution Control Board NOC
- Device Master File (DMF) detailing product specifications and formulation (see our Device Master File guide)
- Plant Master File (PMF) outlining manufacturing processes and facilities (refer to our Plant Master File guide)
- Essential Principles Checklist demonstrating compliance with MDR 2017
- Risk Management File compliant with ISO 14971 standards (learn more about risk management)
- Product Test Reports from CDSCO-approved labs
- Product Labels and Instructions for Use (IFU) conforming to regulatory norms
- Quality Management System (QMS) documentation, preferably ISO 13485 certified
Import License Process for Contact Lens Disinfecting Solutions (MD15)
For companies importing contact lens disinfecting solutions into India, the MD15 import license issued by the Central Licensing Authority is mandatory. The process is as follows:
- Documentation Preparation: Collate 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, and Wholesale License.
- Application Submission: Apply online through the CDSCO MD Online Portal using Form MD14.
- Query Resolution: Respond promptly to any queries raised by CDSCO officials.
- License Grant: On satisfactory review, the MD15 import license is issued.
Import License Documents Required
- Valid Manufacturing License from the country of origin
- Free Sale Certificate confirming the product’s market approval abroad
- ISO 13485:2016 Certificate for QMS
- CE Certificate (if applicable)
- Device Master File
- Plant Master File
- Wholesale License for distribution in India
- Company Constitution
Timeline and Processing Duration
| License Type | Duration | Process Highlights |
|---|---|---|
| MD5 (Manufacturing) | 3 to 4 months total | Includes test license (1.5-2 months), testing, audit |
| MD15 (Import) | 5 to 6 months | Documentation review and query resolution |
Government Fees and Costs
- MD5 License for Class B:
- Application Fee: ₹5,000
- Per Product Fee: ₹500
- MD15 Import License for Class B:
- Site Fee: Approx. $2,000
- Per Product Fee: $1,000
Please note that these fees are subject to change and additional costs may incur for testing, consultancy, and audits.
Common Challenges and Solutions
Challenge 1: Delay in product testing due to backlog at government labs.
Solution: Engage early with notified testing laboratories and consider private labs approved by CDSCO to expedite testing.
Challenge 2: Incomplete documentation leading to query overload.
Solution: Utilize comprehensive checklists for documentation preparation. Our MD5 License Guide offers detailed insights.
Challenge 3: Audit non-compliance due to inadequate QMS.
Solution: Implement ISO 13485:2016 certified QMS prior to audit and conduct internal pre-audits.
Expert Consultation and Support
Navigating CDSCO licensing for contact lens disinfecting solutions can be complex. Our seasoned regulatory consultants have facilitated over 500 successful license grants, ensuring optimized timelines and compliance. We assist with:
- Gap analysis of documentation
- Preparation of Device and Plant Master Files
- Coordination with notified bodies and testing labs
- End-to-end license application management
Getting Started with Your CDSCO License Application
To initiate your journey:
- Assess your product classification: Confirm your device as Class B via the Medical Device Classification tool.
- Prepare your documentation: Begin compiling the Device Master File and Plant Master File using our detailed guides.
- Apply for the Test License (Form MD13): Submit your application on the CDSCO MD Online Portal.
- Plan for product testing: Schedule testing with a CDSCO-approved laboratory.
- Engage a notified body: Select a notified body from the official list for audit readiness.
Early preparation and expert guidance can shorten approval times and prevent costly delays. Contact us today to leverage our 25+ years of regulatory expertise and accelerate your market entry for contact lens disinfecting solutions in India.
