CDSCO License for Injectable implant for the treatment of vesicoureteral reflux

Comprehensive Guide to CDSCO Licensing for Injectable Implants Treating Vesicoureteral Reflux

At our consultancy, with over 25 years of experience and having supported 500+ companies, we understand the complexities involved in obtaining regulatory approvals for sophisticated medical devices like injectable implants for the treatment of vesicoureteral reflux. This internal prosthetic replacement device falls under Risk Class C as per CDSCO regulations, requiring careful navigation of the licensing framework to ensure timely market access in India.

Understanding the CDSCO Regulatory Framework for Injectable Implants

The Central Drugs Standard Control Organization (CDSCO) regulates medical devices in India, categorizing them based on risk. Your injectable implant, classified as a Class C device, is subject to stringent evaluation by the Central Licensing Authority, given its critical role in internal prosthetic replacement.

The applicable notification is 29/Misc/3/2017-DC (18) dated 16.08.2018, which specifically covers devices like injectable implants. Compliance with this notification ensures your device meets safety and efficacy standards mandated by Indian regulators.

Risk Classification and License Requirements for Injectable Implants

Class C devices are considered moderate to high risk, necessitating a MD9 Manufacturing License granted by the Central Licensing Authority. This license is mandatory before manufacturing or marketing your injectable implant in India.

The MD9 license application process includes:

• Obtaining a Test License (Form MD13) to allow testing of your product
• Conducting rigorous product testing at CDSCO-approved laboratories
• Preparing comprehensive technical documentation
• Undergoing a detailed audit by CDSCO inspectors

Manufacturing License Process (MD9) for Class C Devices

The entire process for MD9 licensing typically spans 4 to 5 months, divided into the following stages:

1. Test License Application (Form MD13): Takes approximately 1.5 to 2 months. This allows your device to be legally tested in approved labs.
2. Product Testing: Conduct testing at government-approved laboratories such as those listed on the CDSCO Testing Laboratories portal.
3. Document Preparation: Compile all required documentation including quality management systems and technical files.
4. License Application (Form MD7): Submit your MD9 license application via the CDSCO MD Online Portal.
5. Audit and Inspection: CDSCO inspectors conduct an onsite audit to verify compliance.
6. Query Resolution: Address any questions or deficiencies raised by the department.
7. License Grant (Form MD9): Upon satisfactorily meeting all requirements, the license is issued.

Manufacturing License Documents Required for Injectable Implants

For your injectable implant, ensure submission of the following critical documents:

• Company Constitution: Proof of legal business entity
• Proof of Premises Ownership or Lease: Valid documentation for manufacturing site
• Technical Staff Details: Qualifications and experience of key personnel
• Fire NOC and Pollution Control NOC: Environmental clearances
• Device Master File (DMF): Detailed device specifications and manufacturing process. Our Device Master File guide offers in-depth insights.
• Plant Master File (PMF): Description of manufacturing facility and quality assurance processes. Refer to our Plant Master File guide for preparation tips.
• Essential Principles Checklist: Compliance with Indian medical device regulations
• Risk Management File: Risk analysis and mitigation strategies, which can be optimized following our risk management guidance.
• Test Reports: From CDSCO-approved labs confirming device safety and performance
• Labels and Instructions for Use (IFU): Accurate and regulatory-compliant
• Quality Management System (QMS) Documents: ISO 13485 certification and related procedures

Import License Process (MD15) for Injectable Implants

If you are an importer rather than a manufacturer, you must apply for an MD15 Import License via the Central Licensing Authority. The process generally takes 5 to 6 months and involves:

• Preparing a comprehensive documentation package including the manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016 certification, CE certificate, Device and Plant Master Files, and wholesale license.
• Submitting the application via the CDSCO MD Online Portal.
• Responding to any queries or clarifications raised by the department.
• Upon approval, receiving the MD15 license allowing import and distribution.

Import License Documents Required

Key documents for import license include:

• Valid manufacturing license of the device
• Free Sale Certificate from the country of origin
• ISO 13485:2016 and CE Certificates
• Device Master File and Plant Master File
• Wholesale license
• Company Constitution

Timeline and Processing Duration

Government Fees and Costs

• MD9 Manufacturing License: Rs. 50,000 per application + Rs. 1,000 per product
• Test License (MD13): Fee included in the MD9 process
• MD15 Import License (for Class C devices): Approx. $3,000 per site +$1,500 per product

These fees are payable through the CDSCO portal during application submission.

Common Challenges and Practical Solutions

Challenge 1: Delays in product testing due to lab backlogs

• Solution: Engage with CDSCO-approved laboratories early and schedule testing slots in advance. Utilize the CDSCO Testing Laboratories list to identify multiple options.

Challenge 2: Incomplete documentation leading to application rejections

• Solution: Use experienced consultants to prepare and cross-check your Device and Plant Master Files, QMS documents, and risk management files.

Challenge 3: Audit non-compliance due to facility gaps

• Solution: Conduct internal pre-audits and review the list of notified bodies authorized to perform audits, ensuring your facility meets all regulatory requirements.

Expert Consultation and Support

Navigating the CDSCO licensing process for a Class C device like an injectable implant demands not only regulatory knowledge but also practical experience. Our team has successfully helped over 500 companies obtain their MD9 licenses by providing:

• End-to-end application management
• Documentation drafting and review
• Coordination with testing labs and notified bodies
• Pre-audit readiness assessments
• Query and deficiency resolution

Getting Started with Your CDSCO License Application

1. Determine your device classification precisely to confirm MD9 applicability. You can cross-check on our Medical Device Classification resource.
2. Prepare your Device and Plant Master Files using expert templates and guidance. This foundational step smooths subsequent reviews.
3. Apply for the Test License (MD13) on the CDSCO MD Online Portal, initiating the product testing phase.
4. Schedule product testing promptly at a CDSCO-approved lab to avoid delays.
5. Compile all required documentation including risk management and QMS files.
6. Submit your MD9 license application (Form MD7) through the online portal.
7. Coordinate with CDSCO inspectors for audits and respond to queries efficiently.

Taking these steps systematically will position your injectable implant for successful registration and market entry in India.

For hands-on assistance tailored to your product and business model, reach out to our regulatory experts. With our proven track record, we help you transform regulatory complexities into competitive advantages.