CDSCO License for Neonatal eye pad.
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
A neonatal eye pad is an opaque device used to cover and protect the eye of an infant during therapeutic procedures, such as phototherapy.

Comprehensive Guide to CDSCO Licensing for Neonatal Eye Pads (Class A Medical Device)
Neonatal eye pads serve a vital role in protecting infant eyes during therapeutic procedures like phototherapy. Classified as Class A under the CDSCO framework, these general hospital instruments require strict regulatory compliance to ensure safety and market access in India. With over 25 years of experience and having assisted 500+ companies, we present a detailed, step-by-step guide to securing your CDSCO manufacturing license (MD5) for neonatal eye pads.
CDSCO Regulatory Framework for Neonatal Eye Pads
The Central Drugs Standard Control Organization (CDSCO) regulates medical devices in India under the Medical Devices Rules 2017. Neonatal eye pads fall under the category of General Hospital or Orthopaedic Instruments, specifically notified under Notification 29/Misc./03/2020-DC (193)- Part-3 dated 16.03.2022.
Being a Class A device (low risk), the licensing authority is the State Licensing Authority, and the applicable manufacturing license is the MD5 license. The process mandates compliance with quality standards, product testing, and audit by a notified body.
Risk Classification and License Requirements
- Risk Class: A (Low Risk)
- License Type: MD5 (Manufacturing License for Class A & B devices)
- Licensing Authority: State Licensing Authority
- Application Form: MD3 for license application, MD13 for test license
- Notification Reference: 29/Misc./03/2020-DC (193)- Part-3
Understanding your device’s classification is crucial. For detailed classification guidance, you may refer to the Medical Device Classification resource.
Manufacturing License Process (MD5) for Neonatal Eye Pads
The MD5 license acquisition is a multi-step process:
Apply for Test License (Form MD13): This initial license allows you to manufacture the device for testing purposes. The test license processing time is approximately 1.5 to 2 months.
Conduct Product Testing: The neonatal eye pad samples must be tested in CDSCO-approved laboratories to validate compliance with Indian standards. Refer to the Testing Laboratories for government-approved labs.
Document Preparation: Compile all required documents including Device Master File and Plant Master File.
Apply for MD5 License (Form MD3): Submit your application along with test reports and necessary documents via the CDSCO MD Online Portal.
Audit by Notified Body: A notified body will conduct a facility audit. Check the list of notified bodies prior to audit scheduling.
Query Resolution: Address any observations or queries from the regulatory authority or notified body.
Grant of License: Upon satisfactory compliance, the MD5 license will be issued on Form MD5.
Manufacturing License Documents Required for Neonatal Eye Pads
The following documents are essential to support your MD5 license application:
- Constitution of the company (e.g., Partnership deed, MOA/ AOA)
- Proof of ownership or lease agreement of manufacturing premises
- Qualification and experience details 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 (Plant Master File Guide)
- Essential Principles Compliance Checklist
- Risk Management File demonstrating risk assessment and mitigation (Risk Management)
- Test Reports from CDSCO-approved labs
- Product labels and Instructions for Use (IFU)
- Quality Management System (QMS) documentation (ISO 13485:2016 compliance)
Import License Process (MD15) for Neonatal Eye Pads
For importers intending to bring neonatal eye pads into India, the MD15 license is mandatory. It is issued by the Central Licensing Authority and typically takes 5-6 months. The process involves:
- Preparation of documents including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016 certification, CE certificate, Device Master File, Plant Master File, and Wholesale License.
- Submission of application on the CDSCO MD Online Portal.
- Resolution of queries from CDSCO.
- Final grant of import license (MD15).
Refer to our detailed Import License Guide for comprehensive assistance.
Timeline and Processing Duration
Stage | Approximate Duration |
---|---|
Test License (MD13) | 1.5 - 2 months |
Product Testing | 3 - 4 weeks |
Document Preparation | 2 - 4 weeks |
License Application (MD5) | Submission to audit: 1 month |
Audit by Notified Body | Within 1 month post-application |
Query Resolution | 2 - 4 weeks |
Total Estimated Time | 3 - 4 months |
Government Fees and Costs for MD5 License
- Application Fee: INR 5,000 per application
- Per Product Fee: INR 500 per product
Additional costs may include test lab fees, notified body audit charges, and consultancy fees if applicable.
Common Challenges and Solutions
- Delayed Testing Reports: Engage with CDSCO-approved laboratories early and confirm their testing timelines.
- Incomplete Documentation: Use detailed checklists to ensure all files like Device Master File and Risk Management are thorough.
- Audit Non-Compliance: Conduct pre-audit internal assessments and ensure your QMS is ISO 13485 certified.
- Query Delays: Maintain prompt communication with CDSCO and prepare comprehensive responses.
Expert Consultation and Support
Our extensive experience in CDSCO licensing enables us to streamline your application process, avoid common pitfalls, and ensure timely approvals. We assist in document preparation, audit readiness, and communication with regulatory authorities.
Getting Started with Your CDSCO License Application for Neonatal Eye Pads
Assess and Confirm Device Classification: Verify your neonatal eye pad as Class A under CDSCO regulations.
Register on the CDSCO MD Online Portal: Create your account and familiarize yourself with the application interface.
Engage a CDSCO-Approved Testing Laboratory: Initiate sample testing early to avoid delays.
Prepare Comprehensive Documentation: Utilize our guides on Device Master Files and Plant Master Files to ensure completeness.
Apply for Test License (MD13): Submit your test license application and await approval.
Plan for Notified Body Audit: Schedule your audit with a notified body from the official list.
Submit MD5 License Application: Once test reports and audit outcomes are satisfactory, apply for the manufacturing license.
By following these actionable steps, manufacturers can confidently navigate the CDSCO licensing landscape and bring neonatal eye pads to the Indian market efficiently and compliantly.