CDSCO License for Phoropter
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 mechanical ophthalmic device that is used during an ophthalmic examination; typically to determine a patient's prescription for glasses.
Comprehensive Guide to CDSCO Licensing for Phoropter (Class A Ophthalmic Device)
As a trusted regulatory consultancy with over 25 years of experience and having successfully assisted 500+ companies across India, we understand the nuances of CDSCO licensing for medical devices like the Phoropter. This mechanical ophthalmic device, used extensively to determine patients' eyeglass prescriptions, is classified as a Class A medical device under the Indian regulatory framework. Securing the appropriate CDSCO license is a crucial step to legally manufacture or import Phoropters in India and ensure compliance with the Drugs and Cosmetics Act.
CDSCO Regulatory Framework for Phoropter (Ophthalmic Device)
The Central Drugs Standard Control Organization (CDSCO) regulates medical devices through a risk-based classification system. Phoropters, categorized under ophthalmology devices, fall into the lowest risk Class A category as per the notification Fts No. 29/MiscJO3/2020-DC (187) dated 9.8.2021. For Class A devices, the State Licensing Authority grants manufacturing licenses under the MD5 scheme.
Risk Classification and License Requirements for Phoropter
- Risk Class: A (Low risk)
- License Type: Manufacturing License MD5 (Form MD3)
- Licensing Authority: State Drug Controller
- Applicable Regulation: Medical Devices Rules, 2017
Manufacturers of Phoropters must obtain the MD5 license to legally produce and market this device in India. The process includes obtaining a Test License (Form MD13), product testing, documentation, audit, and final license grant.
Manufacturing License Process for Phoropter (MD5 License)
Test License (Form MD13): Initiate your journey by applying for a Test License, which authorizes you to manufacture the device on a trial basis for testing. This step generally takes 1.5 to 2 months.
Product Testing: Phoropters must be tested at CDSCO-recognized government laboratories to confirm compliance with applicable standards. You can check the list of approved testing laboratories to select an appropriate facility.
Documentation Preparation: Prepare comprehensive technical documentation, including Device Master File, Plant Master File, Essential Principles Checklist, Risk Management File, and Quality Management System (QMS) documents.
Application Submission: Submit your manufacturing license application on Form MD3 through the CDSCO MD Online Portal.
Audit by Notified Body: The State Licensing Authority will arrange an audit by a notified body to verify compliance. Refer to the list of notified bodies to understand audit procedures.
Query Resolution: Respond promptly to any queries raised by the authority or auditors to avoid delays.
Grant of License: Upon successful audit and document review, the license is granted on Form MD5.
Manufacturing License Documents Required for Phoropter
- Company Constitution (Incorporation Certificate/Partnership Deed)
- Proof of Ownership or Lease of Manufacturing Premises
- Details and Qualifications of Technical Staff
- Fire No Objection Certificate (NOC)
- Pollution Control Board NOC
- Device Master File detailing technical specifications and design (See our Device Master File guide)
- Plant Master File describing manufacturing facilities and processes (Plant Master File Guide)
- Essential Principles Compliance Checklist
- Risk Management File aligned with ISO 14971 (Risk Management Overview)
- Test Reports from approved laboratories
- Product Labels and Instructions for Use (IFU)
- Quality Management System Documents (ISO 13485:2016 certification highly recommended)
Import License Process for Phoropter (MD15 License)
While your primary focus may be manufacturing, if you plan to import Phoropters, a separate MD15 import license from the Central Licensing Authority is mandatory. This process takes approximately 5-6 months and requires submission of detailed documentation including your manufacturing license, Free Sale Certificate, ISO and CE certifications, and company documents. For comprehensive guidance, refer to our Import License guide.
Import License Documents Required
- Valid Manufacturing License from country of origin
- Free Sale Certificate
- ISO 13485:2016 Certificate
- CE Certificate
- Device Master File
- Plant Master File
- Wholesale License
- Company Constitution Documents
Timeline and Processing Duration
| Step | Duration |
|---|---|
| Test License (MD13) | 1.5 – 2 months |
| Product Testing | 2 – 3 weeks |
| Documentation Prep | 3 – 4 weeks |
| Audit & Review | 4 – 6 weeks |
| Query Resolution & Grant | 2 – 3 weeks |
| Total Approximate Time | 3 – 4 months |
Government Fees and Costs
- Application Fee: Rs. 5000 per license application
- Product Fee: Rs. 500 per product (Phoropter as a single product)
- Testing & Audit Costs: Variable depending on notified body and lab fees
Budgeting for the entire process, including regulatory consultancy, testing, and audit fees, is essential. We recommend setting aside approximately Rs. 1,00,000 to Rs. 1,50,000 for a smooth process.
Common Challenges and Practical Solutions
Incomplete Documentation: Many applicants face delays due to missing or inadequate documents. We advise preparing documents meticulously and using checklists to avoid rejections.
Delays in Testing: Selecting efficient government-approved laboratories and pre-coordinating sample submissions can reduce testing delays.
Audit Non-Compliance: Preparing your manufacturing facility and QMS proactively before the audit ensures a smooth review.
Query Management: Prompt and clear responses to regulatory queries can significantly expedite license grant.
Expert Consultation and Support
Navigating the CDSCO licensing landscape for devices like the Phoropter can be complex. Our team offers end-to-end support from initial gap analysis, document preparation, test coordination, audit preparation, to final license submission. Leveraging our extensive network of notified bodies and testing labs, we streamline the entire process.
Getting Started with Your CDSCO License Application for Phoropter
Assess Your Readiness: Review your current manufacturing setup and documentation against CDSCO requirements.
Register on CDSCO MD Online Portal: Create your account and familiarize yourself with the application process.
Engage a Regulatory Expert: Consider partnering with experienced consultants to avoid common pitfalls.
Initiate Test License Application (Form MD13): This is your gateway to begin manufacturing trials and testing.
Plan for Product Testing: Schedule your product testing at a CDSCO-recognized laboratory early on.
By following these actionable steps and leveraging expert assistance, manufacturers and importers can successfully obtain the MD5 license for Phoropter and establish a compliant presence in the Indian market.
For detailed guidance, visit the official CDSCO MD Online Portal and explore related resources to ensure up-to-date compliance.
We look forward to supporting your journey in bringing high-quality ophthalmic devices like the Phoropter to the Indian healthcare ecosystem.
