CDSCO License for Electronic occlusion spectacles

Comprehensive Guide to CDSCO Licensing for Electronic Occlusion Spectacles (Class A Ophthalmic Device)

Electronic occlusion spectacles are specialized ophthalmic devices designed to test and train vision, particularly for patients experiencing decreased visual acuity due to unequal vision in the eyes. As a Class A medical device under Indian regulations, these spectacles require compliance with the Central Drugs Standard Control Organization (CDSCO) for manufacturing and import licensing. With over 25 years of experience and having assisted 500+ companies, we provide a detailed roadmap to help you navigate the CDSCO licensing process effectively.

CDSCO Regulatory Framework for Electronic Occlusion Spectacles

The CDSCO classifies medical devices into Classes A, B, C, and D based on risk, with Class A representing low risk devices like Electronic Occlusion Spectacles. This classification follows the notification Fts No. 29/MiscJO3/2020-DC (187) dated 9.8.2021. For Class A devices, manufacturing licenses are granted by the State Licensing Authority, while import licenses are issued by the Central Licensing Authority.

Risk Classification and License Requirements

Electronic Occlusion Spectacles fall under Class A, requiring an MD5 manufacturing license when produced domestically. This involves submitting Application Form MD3 on the CDSCO MD Online Portal. If you plan to import, an MD15 import license (Form MD14) from the central authority is mandatory. The low-risk classification means the licensing process is relatively straightforward but requires strict adherence to documentation and testing.

Manufacturing License Process for Electronic Occlusion Spectacles (MD5 License)

Step 1: Obtain Test License (Form MD13)

Before applying for the MD5 license, manufacturers must first obtain a test license, which typically takes 1.5 to 2 months. This license allows sample testing of the product in government-approved laboratories.

Step 2: Product Testing

Testing is critical and must be conducted in CDSCO-recognized labs. For a list of these labs, manufacturers can refer to the Testing Laboratories directory.

Step 3: Document Preparation

Prepare comprehensive documents including the Device Master File, Plant Master File, Risk Management File, and Quality Management System (QMS) documentation. Our Device Master File guide and Plant Master File guide provide practical templates and tips.

Step 4: License Application (Form MD3)

Submit your application through the CDSCO MD Online Portal. Ensure all documents are accurate and complete to avoid delays.

Step 5: Audit by Notified Body

An audit by an approved notified body is required. Find the appropriate auditor from the Notified Bodies list.

Step 6: Query Resolution

Be prepared to respond promptly to any queries from the CDSCO or the notified body.

Step 7: Grant of License

Once compliance is confirmed, the MD5 license (Form MD5) will be granted, typically within 3-4 months from the initial test license application.

Manufacturing License Documents Required

• Company Constitution (e.g., Memorandum and Articles of Association)
• Proof of Ownership or Lease Agreement of Manufacturing Premises
• Details of Technical Staff (qualifications and experience)
• Fire and Pollution NOCs
• Device Master File (DMF)
• Plant Master File (PMF)
• Essential Principles Checklist for the device
• Risk Management File complying with ISO 14971
• Test Reports from CDSCO-approved labs
• Labels, Instructions for Use (IFU)
• Quality Management System Documents (ISO 13485 certification preferred)

Import License Process for Electronic Occlusion Spectacles (MD15 License)

Importers must apply for an MD15 license using Form MD14. The process includes:

• Document preparation including Manufacturing License from the country of origin, Free Sale Certificate, ISO 13485:2016, CE Certificate, DMF, and PMF.
• Application submission via the CDSCO MD Online Portal.
• Queries resolution, typically within 5-6 months.

Notably, no test license is required for imports, but all documents must demonstrate compliance with Indian standards and safety requirements.

Import License Documents Required

• Valid Manufacturing License from the country of origin
• Free Sale Certificate
• ISO 13485:2016 Certificate
• CE Certificate or equivalent international standard
• Device Master File and Plant Master File
• Wholesale License
• Company Constitution

Timeline and Processing Duration

Government Fees and Costs

• MD5 Manufacturing License:
  • Rs. 5000 per application
  • Rs. 500 per product
• MD15 Import License:
  • Class A: $1000 per site,$50 per product

Additional costs include testing fees at government-approved labs, audit fees by notified bodies, and consultancy if required.

Common Challenges and Solutions

Challenge: Delays due to incomplete documentation

Solution: Use our comprehensive checklists and guides to ensure all documents meet CDSCO requirements before submission.

Challenge: Difficulty in coordinating audits and testing

Solution: Schedule audits early, select notified bodies from the official Notified Bodies list, and book testing slots promptly.

Challenge: Navigating complex regulatory changes

Solution: Stay updated with CDSCO notifications and seek expert consultancy to interpret changes impacting your device.

Expert Consultation and Support

With over 25 years of regulatory consulting experience, we offer tailored support for Electronic Occlusion Spectacles manufacturers and importers. Our services include document preparation, audit coordination, application filing, and post-approval compliance monitoring to ensure a smooth regulatory journey.

Getting Started with Your CDSCO License Application

1. Assess Device Classification: Confirm your device is Class A using the Medical Device Classification guide.
2. Prepare Documentation: Begin compiling all technical and legal documents using our detailed templates.
3. Apply for Test License: Submit Form MD13 via the CDSCO MD Online Portal.
4. Coordinate Testing: Arrange product testing at CDSCO-approved laboratories.
5. Plan for Audit: Contact a notified body early to schedule your audit.
6. Submit MD5 Application: Once test results and audit reports are ready, file Form MD3.
7. Respond to Queries: Maintain open communication with CDSCO officials to resolve any queries swiftly.

Embarking on the CDSCO licensing process can be complex, but with a structured approach and expert guidance, manufacturers and importers of Electronic Occlusion Spectacles can successfully enter the Indian market. For personalized assistance, contact us to leverage our extensive regulatory expertise and ensure compliance from day one.