CDSCO License for Scleral expansion implant

Comprehensive Guide to CDSCO Licensing for Scleral Expansion Implant (Class C Medical Device)

Scleral expansion implants are specialized ophthalmic devices designed for implantation in the sclera to induce expansion by altering the position of the underlying ciliary muscle. This innovative device category falls under Class C risk classification according to the Central Drugs Standard Control Organization (CDSCO) regulations, given its invasive nature and critical role in ocular function.

Navigating the regulatory landscape for such advanced ophthalmic implants demands expert knowledge and meticulous preparation. With over 25 years of experience and having supported 500+ companies in obtaining CDSCO licenses, we provide you with a comprehensive, step-by-step guide to secure your MD9 manufacturing license and import license efficiently.

CDSCO Regulatory Framework for Scleral Expansion Implants

The CDSCO regulates all medical devices in India under the Medical Device Rules (MDR), 2017, focusing on ensuring safety, quality, and performance. Scleral expansion implants, due to their implantable nature and potential impact on vital functions, are classified as Class C devices. This classification mandates stringent regulatory scrutiny including product testing, audits, and comprehensive documentation.

The governing notification for this device is Fts No. 29/MiscJO3/2020-DC (187), dated 9.8.2021, which officially classifies scleral expansion implants under Class C, subjecting manufacturers and importers to the MD9 licensing pathway.

Risk Classification and License Requirements

Class C devices are considered moderate to high risk. Accordingly, the CDSCO requires:

• Manufacturing License: MD9 license granted by the Central Licensing Authority.
• Import License: MD15 license for importers.

The MD9 license application involves rigorous product testing, audits by CDSCO inspectors, and extensive documentation to demonstrate compliance with safety and efficacy standards.

Manufacturing License Process for Scleral Expansion Implant (MD9 License)

The MD9 manufacturing license process consists of several key steps:

1. Test License Application (Form MD13)

   • Apply for a test license to manufacture samples for testing.
   • Processing time: 1.5 to 2 months.

2. Product Testing

   • Conduct testing at government-approved laboratories.
   • Testing parameters include biocompatibility, sterility, mechanical strength, and performance as per notified standards.
   • Refer to the list of testing laboratories for accredited centers.

3. Document Preparation

   • Compile required documents including Device Master File (DMF), Plant Master File (PMF), Risk Management File, and Essential Principles Checklist.
   • See our detailed Device Master File guide and Plant Master File guide for assistance.

4. Application Submission (Form MD7)

   • Submit the manufacturing license application via the CDSCO MD Online Portal.

5. Audit by CDSCO Inspectors

   • CDSCO conducts a thorough audit of manufacturing facilities, quality systems, and documentation.
   • Review the list of notified bodies for audit requirements.

6. Resolution of Queries

   • Address any observations or deficiencies raised during audits or by CDSCO.

7. License Grant (Form MD9)

   • Upon successful compliance, the MD9 manufacturing license is granted.

Manufacturing License Documents Required for Scleral Expansion Implant

Precise documentation is critical to avoid delays. Required documents include:

• Company Constitution and Incorporation Certificates.
• Proof of Premises Ownership or Lease Agreement.
• Details of Technical Staff and Qualifications.
• Fire NOC and Pollution Control Board NOC.
• Device Master File (DMF) including device description, design, and manufacturing process.
• Plant Master File (PMF) outlining manufacturing facilities and quality control procedures.
• Essential Principles Checklist demonstrating compliance with safety standards.
• Risk Management File detailing hazard identification and mitigation strategies.
• Product Test Reports from accredited labs.
• Product Labels and Instructions for Use (IFU).
• Quality Management System (QMS) documentation, preferably ISO 13485:2016 certification.

Import License Process for Scleral Expansion Implant (MD15 License)

Importers must obtain an MD15 license from the Central Licensing Authority. The process includes:

1. Document Preparation

   • Gather required documentation including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016 certificate, CE certificate, DMF, PMF, and Wholesale License.

2. Application Submission (Form MD14)

   • Submit the import license application through the CDSCO MD Online Portal.

3. Queries Resolution

   • Respond promptly to any CDSCO queries.

4. License Grant (Form MD15)

   • Receive the import license to legally import the scleral expansion implant.

Import License Documents Required

• Valid Manufacturing License (MD9 or equivalent) from country of origin.
• Free Sale Certificate issued by the regulatory authority of the exporting country.
• ISO 13485:2016 certification.
• CE Certificate or equivalent.
• Device Master File and Plant Master File.
• Wholesale Drug License.
• Company Constitution Documents.

Timeline and Processing Duration

• MD9 Manufacturing License: Typically 4 to 5 months including test license, product testing, audits, and final approval.
• Test License (MD13): 1.5 to 2 months.
• Product Testing: Usually 1 to 2 months depending on laboratory workload.
• Import License (MD15): Approximately 5 to 6 months.

Planning ahead and timely submission of complete documents can significantly reduce processing times.

Government Fees and Costs

For Class C devices such as scleral expansion implants:

• MD9 License Fees:

  • Application fee: Rs. 50,000
  • Per product fee: Rs. 1,000

• Test License Fees (MD13): As per CDSCO norms, generally included in the overall process cost.

• Import License (MD15) Fees:

  • Site Fee: USD 3,000
  • Product Fee: USD 1,500 per product

These fees are payable online through the CDSCO portal.

Common Challenges and Solutions

Challenge 1: Delay in Product Testing

• Solution: Engage with accredited laboratories early and confirm testing protocols and timelines. Refer to the CDSCO Testing Laboratories for selection.

Challenge 2: Incomplete Documentation

• Solution: Use comprehensive checklists and expert consultation to ensure every document, such as DMF, PMF, and Risk Management Files, are complete and compliant.

Challenge 3: Audit Non-Compliance

• Solution: Conduct internal mock audits and implement robust QMS aligned with ISO 13485:2016 standards to meet CDSCO requirements.

Challenge 4: Query Resolution Delays

• Solution: Maintain open communication channels with CDSCO and respond to queries within stipulated timelines to avoid application rejection.

Expert Consultation and Support

Given the complexity of Class C medical device licensing, partnering with experienced regulatory consultants can streamline the process. We have successfully guided over 500 companies through the CDSCO licensing journey, ensuring compliance and faster approvals.

Our services include:

• Tailored regulatory strategy for scleral expansion implants.
• Comprehensive document preparation and review.
• Coordination with notified bodies and testing laboratories.
• Support during audits and query resolution.

Getting Started with Your CDSCO License Application

1. Assess Your Device Classification: Confirm your scleral expansion implant is Class C as per CDSCO's notification dated 9.8.2021.

2. Initiate Test License Application (MD13): Prepare your technical and manufacturing documents and submit through the CDSCO MD Online Portal.

3. Select Accredited Testing Laboratory: Schedule product testing early with a government-approved lab.

4. Prepare Documentation: Develop your Device Master File, Plant Master File, Risk Management File, and QMS documents.

5. Schedule Audit Preparation: Align your manufacturing facility and quality systems with CDSCO audit requirements.

6. Submit MD9 License Application: Once test license and testing are complete, apply for the MD9 license and track your application online.

7. Plan for Import Licensing: If you are an importer, concurrently prepare for the MD15 license application.

Embarking on this structured approach ensures compliance, minimizes delays, and positions your scleral expansion implant for successful entry into the Indian market.

For tailored assistance and expert regulatory support, contact our team to leverage our 25+ years of experience in CDSCO licensing for ophthalmic medical devices.