CDSCO License for Ophthalmic refractometer

Comprehensive CDSCO Licensing Guide for Ophthalmic Refractometer – Class B Medical Device

As seasoned regulatory consultants with over 25 years of experience and having successfully assisted 500+ companies, we understand the critical importance of securing your CDSCO license to market ophthalmic devices such as the Ophthalmic Refractometer in India. This automatic, AC-powered ophthalmic instrument, designed to measure refractive power by analyzing retinal light reflexes, falls under Class B risk category as per CDSCO notification Fts No. 29/MiscJO3/2020-DC (187) dated 9.8.2021.

Navigating the regulatory landscape efficiently ensures timely market access, compliance with Indian Medical Device Rules, and uninterrupted business operations. This detailed guide covers the regulatory framework, license types, documentation, timelines, fees, and practical tips tailored for your Ophthalmic Refractometer.

CDSCO Regulatory Framework for Ophthalmic Refractometer

The Central Drugs Standard Control Organization (CDSCO) regulates medical devices in India under the Medical Device Rules, 2017, enforced by the Ministry of Health and Family Welfare. The Ophthalmic Refractometer is categorized under ophthalmology devices and classified as a Class B device due to moderate risk.

Since it is a Class B device, the applicable manufacturing license is the MD5 license granted by the State Licensing Authority. Importers will require the MD15 import license from the Central Licensing Authority.

Manufacturers and importers must comply with the Medical Device Rules, including product testing, quality management system implementation, and audit requirements.

Risk Classification and License Requirements for Ophthalmic Refractometer

• Device Risk Class: Class B (Moderate risk)
• Applicable License for Manufacturing: MD5 License (Application Form MD3)
• Applicable License for Import: MD15 License (Application Form MD14)
• Regulatory Authority: State Licensing Authority for manufacturing, Central Licensing Authority for import

You can verify the device classification and notifications on the official Medical Device Classification page.

Manufacturing License Process for Ophthalmic Refractometer (MD5 License)

The MD5 license process is comprehensive and typically takes 3-4 months, involving several crucial steps:

1. Test License Application (Form MD13): Before manufacturing license submission, manufacturers must obtain a test license to validate the product through government-approved testing laboratories. This takes approximately 1.5 to 2 months.

2. Product Testing: Conduct product testing at CDSCO notified labs to generate mandatory test reports. You can find the list of authorized Testing Laboratories here.

3. Document Preparation and Compilation: Prepare the complete dossier including Device Master File, Plant Master File, Risk Management File, Essential Principles Checklist, and QMS documentation.

4. Application Submission: Submit Form MD3 via the CDSCO MD Online Portal along with prescribed fees.

5. Notified Body Audit: The facility undergoes an audit by a notified body to verify compliance. Refer to the List of Notified Bodies for audit agencies.

6. Resolution of Queries: Address any deficiencies or queries raised by the licensing authority or notified body promptly.

7. License Grant: Upon satisfactory compliance, the MD5 License is issued in Form MD5 allowing manufacturing of the Ophthalmic Refractometer.

For in-depth guidance, refer to our MD5 License Guide.

Manufacturing License Documents Required for Ophthalmic Refractometer

The documentation package is extensive and must be meticulously prepared:

• Company Constitution (Incorporation Certificate, MOA/AOA)
• Proof of ownership or valid lease agreement of manufacturing premises
• Technical staff qualifications and experience certificates
• Fire safety NOC
• Pollution control NOC
• Device Master File detailing design, specifications, and manufacturing processes (Guide to Device Master File)
• Plant Master File describing manufacturing facility and quality controls (Plant Master File Guide)
• Essential Principles Checklist ensuring compliance with safety and performance standards
• Risk Management File highlighting identified risks and mitigation steps (Risk Management)
• Product Test Reports from CDSCO-approved labs
• Labels and Instructions for Use (IFU) complying with CDSCO requirements
• Quality Management System (QMS) documents aligned with ISO 13485:2016

Import License Process for Ophthalmic Refractometer (MD15 License)

For importers, the MD15 license is mandatory and granted by the Central Licensing Authority. The process generally takes around 5-6 months and entails:

1. Document Preparation: Assemble requisite documents including manufacturing license, Free Sale Certificate from the country of origin, ISO 13485:2016 certificate, CE Certificate (if applicable), Device and Plant Master Files, wholesale license, and company constitution.

2. Application Submission: File Form MD14 on the CDSCO MD Online Portal.

3. Evaluation and Queries: The authority reviews the documents and may request clarifications.

4. License Issuance: Upon successful review, the MD15 import license is granted.

For detailed procedural insights, see our Import License Guide.

Import License Documents Required for Ophthalmic Refractometer

• Manufacturing License of the device in the country of origin
• Free Sale Certificate or Certificate of Marketability
• ISO 13485:2016 Certification
• CE Certificate or equivalent (if applicable)
• Device Master File
• Plant Master File
• Wholesale License for distribution
• Company Constitution and legal documents

Timeline and Processing Duration for Ophthalmic Refractometer CDSCO Licenses

Timely submission of complete and accurate documents can help avoid delays.

Government Fees and Costs for Ophthalmic Refractometer Licensing

• MD5 Manufacturing License:

  • Application Fee: ₹5,000 per application
  • Product Fee: ₹500 per product

• MD15 Import License:

  • Class B Device Fees: Approximately $2,000 per site and$1,000 per product

Investing in professional assistance for documentation and audit preparation can save costs associated with rejections or delays.

Common Challenges and Solutions

• Incomplete Documentation: Missing or inconsistent documents cause prolonged queries. Solution: Use comprehensive checklists and pre-audit reviews.

• Testing Delays: Delays in scheduling tests at notified labs. Solution: Book slots early and maintain good communication with labs.

• Audit Non-compliance: Facility or QMS gaps identified during audit. Solution: Conduct internal audits and gap assessments before notified body inspections.

• Query Resolution Delays: Slow response to CDSCO queries extends timelines. Solution: Have a dedicated regulatory team promptly address queries.

Expert Consultation and Support

With our extensive experience, we assist manufacturers and importers through every step—from test license acquisition, dossier preparation, navigating audits by notified bodies, to final license issuance. Our proactive approach minimizes rejections and accelerates approvals.

We also provide tailored training on risk management, QMS compliance, and post-market surveillance requirements to ensure continuous regulatory adherence.

Getting Started with Your CDSCO License Application

1. Assess Device Classification: Confirm your Ophthalmic Refractometer’s Class B status using official classification resources.

2. Engage Early with Testing Labs: Initiate contact with CDSCO-approved testing laboratories to schedule testing.

3. Prepare Device & Plant Master Files: Develop detailed technical documentation and facility descriptions.

4. Implement QMS: Ensure ISO 13485:2016 aligned QMS is operational.

5. Submit Test License Application: File Form MD13 through the CDSCO MD Online Portal.

6. Plan for Notified Body Audit: Identify and liaise with a notified body from the official List of Notified Bodies.

7. Compile and Submit Manufacturing License Application: Complete Form MD3 and submit once test license and product testing are complete.

8. Prepare for Query Management: Assign a regulatory liaison for timely response.

By following these actionable steps and leveraging expert support, your path to CDSCO approval for the Ophthalmic Refractometer can be smooth and efficient, unlocking the vast Indian ophthalmology market.

For personalized assistance, contact our regulatory consultants who have empowered 500+ companies to succeed in the Indian medical device sector.