CDSCO License for Surgical lamp
Medical Device Information
Important Notice for Class A Devices
Class A Non-sterile Non Measuring devices are exempt from MD5 and MD15 licenses. Only CDSCO registration is required as per GSR 777(E).
Intended Use
Identification. A surgical lamp (including a fixture) is a device intended to be used to provide visible illumination of the surgical field or the patient.
Comprehensive Guide to CDSCO Licensing for Surgical Lamps (Class A Medical Devices)
Surgical lamps are essential medical devices designed to provide clear, visible illumination of the surgical field or patient during procedures. Categorized under Dermatological & Plastic Surgery devices, these lamps play a crucial role in ensuring surgical precision and patient safety. Given their critical application, regulatory compliance with the Central Drugs Standard Control Organization (CDSCO) is mandatory for manufacturers and importers aiming to market surgical lamps in India.
With over 25 years of experience and having guided 500+ companies through the CDSCO licensing maze, we provide you with a detailed, practical roadmap for securing your CDSCO license for surgical lamps classified as Class A devices.
CDSCO Regulatory Framework for Surgical Lamps
Surgical lamps fall under the regulatory framework of medical devices notified by CDSCO under the Drugs and Cosmetics Act. The specific notification governing this device is 29/Misc./03/2020-DC (147), dated 26.7.2021, which classifies surgical lamps as Class A (low risk) devices.
As per the Medical Device Rules (MDR) 2017 and subsequent amendments, Class A devices require licensing from the State Licensing Authority through the MD5 license process. This ensures that the device meets quality and safety standards before entering the Indian market.
Risk Classification and License Requirements for Surgical Lamps
Surgical lamps are categorized as Class A devices, indicating low risk. This classification impacts the licensing process:
- License Type: MD5 Manufacturing License
- Application Form: MD3 for manufacturing license
- Licensing Authority: State Licensing Authority
- Typical Timeline: 3-4 months (including test license, product testing, audit, and final approval)
- Fees: ₹5,000 per application + ₹500 per product
This process mandates a systematic approach involving a test license, product testing at government-approved labs, documentation, and a notified body audit.
Manufacturing License Process (MD5) for Surgical Lamps
The MD5 license process for Class A surgical lamps is comprehensive, ensuring quality assurance at every step:
Obtain Test License (Form MD13): This preliminary license allows manufacturing and testing of the surgical lamp. The test license application typically takes 1.5 to 2 months to process.
Product Testing: Conduct mandatory testing at CDSCO-approved laboratories. Testing parameters include electrical safety, photometric performance, and compliance with relevant Indian standards. You can find the list of government-approved testing labs here.
Documentation Preparation: Compile required documents such as Device Master File, Plant Master File, Risk Management File, and Essential Principles Checklist.
Application Submission (Form MD3): Submit the manufacturing license application through the CDSCO MD Online Portal.
Notified Body Audit: Arrange for an audit by a CDSCO-recognized notified body to assess compliance with Good Manufacturing Practices (GMP) and QMS.
Queries Resolution: Address any queries or observations raised by the licensing authority or notified body promptly.
License Grant (Form MD5): Upon satisfactory review and audit, the State Licensing Authority grants the manufacturing license.
For detailed guidance, refer to our MD5 License Guide.
Manufacturing License Documents Required for Surgical Lamps
To streamline your application, ensure you have the following documents prepared and verified:
- Company Constitution: Incorporation certificate, partnership deed, or LLP agreement
- Proof of Ownership or Lease of Premises: Valid documents proving possession of manufacturing site
- Technical Staff Credentials: Qualification and experience certificates of key technical personnel
- Fire NOC: No Objection Certificate from Fire Department
- Pollution Control Board NOC: Environmental clearance where applicable
- Device Master File (DMF): Detailed technical dossier covering design, specifications, and materials used. Our Device Master File guide offers practical insights.
- Plant Master File (PMF): Information about manufacturing facilities and quality systems; see our Plant Master File Guide for templates and tips.
- Essential Principles Checklist: Demonstrating compliance with Indian Essential Principles of Safety and Performance
- Risk Management File: Documentation of risk analysis and mitigation strategies. Learn more about implementing risk management.
- Test Reports: From government-approved laboratories
- Labels and Instructions for Use (IFU): Compliant with CDSCO labeling requirements
- Quality Management System (QMS) Documents: ISO 13485:2016 certification and SOPs
Import License Process (MD15) for Surgical Lamps
While your surgical lamp is a Class A device, if you plan to import, an MD15 import license from CDSCO’s Central Licensing Authority is mandatory.
Key steps include:
Documentation Preparation: Including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016, CE Certificate (if applicable), Device and Plant Master Files, Wholesale License, and Company Constitution.
Application Submission: On the CDSCO MD Online Portal.
Queries Resolution: Respond to any departmental queries.
License Grant: Typically takes 5-6 months.
For a detailed roadmap, consult our Import License Guide.
Import License Documents Required
- Valid Manufacturing License from the country of origin
- Free Sale Certificate
- ISO 13485:2016 Certificate
- CE Certificate (if applicable)
- Device Master File
- Plant Master File
- Wholesale License
- Company Constitution
Timeline and Processing Duration for Surgical Lamp Licensing
| Stage | Duration |
|---|---|
| Test License (MD13) | 1.5 - 2 months |
| Product Testing | 3 - 4 weeks |
| Document Preparation | 2 - 3 weeks |
| Application Submission & Audit | 4 - 6 weeks |
| Queries Resolution | 2 - 3 weeks |
| Total Time | 3 - 4 months |
This timeline assumes prompt responses and no major deficiencies during audit.
Government Fees and Costs for Surgical Lamps
- Test License Fee: Included in application process
- MD5 Manufacturing License Fees: ₹5,000 per application + ₹500 per product
- Testing Costs: Variable based on lab and number of tests; typically ₹50,000 - ₹1,00,000
- Notified Body Audit Fees: Approximately ₹1,00,000 - ₹2,00,000 depending on scope
Budgeting for these costs early helps avoid surprises and delays.
Common Challenges and Solutions in CDSCO Licensing for Surgical Lamps
- Incomplete Documentation: Meticulously prepare your Device and Plant Master Files using expert templates.
- Delays in Testing: Engage with government-approved labs early; pre-book testing slots.
- Audit Non-Compliance: Conduct internal audits and mock inspections before notified body visits.
- Regulatory Queries: Assign a dedicated regulatory liaison to ensure timely, accurate responses.
Our hands-on experience equips us to help you navigate these hurdles efficiently.
Expert Consultation and Support
Our team has assisted over 500 manufacturers and importers in successfully obtaining CDSCO licenses. We offer:
- Customized gap analysis for your surgical lamp device
- End-to-end documentation preparation
- Coordination with notified bodies and testing labs
- Strategic scheduling to meet your market entry timelines
We ensure your licensing journey is smooth, compliant, and cost-effective.
Getting Started with Your CDSCO License Application for Surgical Lamps
Assess Your Device Classification: Confirm your surgical lamp falls under Class A. Use the Medical Device Classification resource.
Initiate Test License Application: Prepare preliminary documents and submit Form MD13 on the CDSCO MD Online Portal.
Engage Testing Laboratories: Coordinate with notified labs early; refer to the Testing Laboratories list.
Prepare Technical Documentation: Develop comprehensive Device Master and Plant Master Files.
Plan for Notified Body Audit: Identify and schedule audits with notified bodies listed here.
Submit Manufacturing License Application: Upon successful test license and testing, apply for MD5 license via the CDSCO portal.
Maintain Open Communication: Stay proactive in resolving any queries from CDSCO or notified bodies.
By following these actionable steps, your surgical lamp manufacturing or import licensing process will be efficient and compliant, setting the foundation for success in the Indian medical device market.
For personalized assistance and to leverage our 25+ years of regulatory expertise, contact us today and ensure your surgical lamp meets all CDSCO regulatory requirements seamlessly.
