CDSCO License for Distractor/Retractors

Comprehensive CDSCO Licensing Guide for Distractor/Retractors (Class A Medical Device)

As a surgical device designed to separate connected surfaces and hold them in position during operations, Distractor/Retractors fall under Class A medical devices in India’s regulatory framework. With over 25 years of expertise and having assisted more than 500 companies, we provide you with a detailed, practical roadmap to successfully obtain your CDSCO license, ensuring your entry into the Indian market is smooth and compliant.

Understanding Distractor/Retractors and Their Regulatory Importance

Distractor/Retractors are essential in operation theatres for facilitating precise surgical procedures by maintaining separation between tissues. Given their critical role, even though classified as Class A (low risk), they require stringent adherence to CDSCO regulations to guarantee patient safety and product quality.

The notified file number for Distractor/Retractors is 29/Misc/03/2020-DC (199), with the notification dated 13.09.2021, confirming its official classification under the CDSCO medical device regulatory framework.

CDSCO Regulatory Framework for Distractor/Retractors

Being a Class A device, the regulatory oversight is primarily handled by the State Licensing Authority. The applicable license for manufacturing is the MD5 license, processed via Form MD3. The entire licensing process integrates multiple stages including obtaining a test license, product testing at government-approved laboratories, audit by notified bodies, and final license issuance.

You must submit your application through the CDSCO MD Online Portal, which streamlines documentation and communication.

Risk Classification and License Requirements

• Risk Class: A (Low risk)
• License Type: MD5 Manufacturing License
• Authority: State Licensing Authority
• Application Form: MD3
• Estimated Timeline: 3-4 months
• Fee Structure: Rs 5,000 per application + Rs 500 per product

For more on device classification, you can refer to our comprehensive Medical Device Classification guide.

Manufacturing License Process for Distractor/Retractors (MD5)

1. Test License (Form MD13):

   • First, apply for a test license which typically takes 1.5 to 2 months.
   • This allows product testing from CDSCO-approved laboratories.

2. Product Testing:

   • Get your Distractor/Retractors tested at one of the government-approved testing laboratories.
   • Ensure the test reports comply with the Essential Principles Checklist.

3. Document Preparation:

   • Compile all required documents, including Device Master File and Plant Master File.

4. Application Submission:

   • Submit your application for the MD5 license through the CDSCO MD Online Portal.

5. Audit by Notified Body:

   • The notified body conducts a thorough audit of your manufacturing premises and QMS.
   • Find a suitable auditor from the list of notified bodies.

6. Query Resolution:

   • Address any queries from the department or notified body promptly to avoid delays.

7. License Grant:

   • Upon successful audit and query resolution, the State Licensing Authority grants the MD5 license (Form MD5).

Manufacturing License Documents Required

For Distractor/Retractors, the following documentation is mandatory:

• Company constitution and registration proof
• Proof of ownership or lease agreement of manufacturing premises
• Details and qualifications of technical staff
• Fire No Objection Certificate (NOC)
• Pollution Control Board NOC
• Device Master File (DMF) – a detailed dossier covering design, specifications, and manufacturing processes. Our Device Master File guide provides a step-by-step approach.
• Plant Master File (PMF) – outlining the manufacturing environment and quality controls. Refer to our Plant Master File guide.
• Essential Principles Checklist and Risk Management File, documenting compliance with safety standards. Learn more about risk management processes.
• Test reports from CDSCO-approved labs
• Labeling and Instructions for Use (IFU) complying with regulatory requirements
• Quality Management System (QMS) documentation aligned with ISO 13485

Import License Process for Distractor/Retractors (MD15)

Since Distractor/Retractors are Class A, importers must apply for an MD15 license from the Central Licensing Authority. The process includes:

• Document preparation including manufacturing license, Free Sale Certificate, ISO 13485 certification, CE Certificate, Device and Plant Master Files.
• Submission of application via Form MD14 through the CDSCO MD Online Portal.
• Resolution of any departmental queries.
• Grant of import license (Form MD15).

The typical processing time is 5-6 months.

Import License Documents Required

Key documents include:

• Valid manufacturing license of the foreign manufacturer
• Free Sale Certificate issued by the country of origin
• ISO 13485:2016 certification
• CE Certificate (if applicable)
• Device Master File and Plant Master File
• Wholesale license for storage and distribution
• Company constitution and registration documents

Timeline and Processing Duration

Total: Approximately 3-4 months for manufacturing license.

Government Fees and Costs

• MD5 Manufacturing License:

  • Rs 5,000 per application
  • Rs 500 per product

• Test License (MD13):

  • Fees vary, generally included in application fees.

Budgeting for notified body audits and testing lab fees is essential, typically ranging from Rs 50,000 to Rs 1,00,000 depending on the scope.

Common Challenges and Practical Solutions

• Delays in Test Reports:

  • Mitigate by pre-selecting CDSCO-approved labs and scheduling tests early.

• Incomplete Documentation:

  • Use detailed checklists and expert reviews before submission.

• Audit Non-Compliance:

  • Conduct internal pre-audits using notified body criteria.

• Query Backlogs:

  • Maintain prompt communication channels and prepare clarifications in advance.

Expert Consultation and Support

Navigating the CDSCO licensing can be complex. Our team provides:

• End-to-end guidance from document preparation to audit support
• Liaison with CDSCO officials and notified bodies
• Customized training on compliance and quality management

Our extensive experience ensures your Distractor/Retractors are market-ready with minimal regulatory hurdles.

Getting Started with Your CDSCO License Application

1. Assess Your Device Classification: Confirm Class A status and licensing requirements.
2. Prepare Required Documents: Follow our guides on Device Master File and Plant Master File.
3. Apply for Test License (MD13): Submit through the CDSCO MD Online Portal.
4. Schedule Product Testing: Coordinate with CDSCO-approved laboratories early.
5. Select a Notified Body: Choose from the official notified bodies list for your audit.
6. Submit MD5 Application: After test reports and documentation are ready.
7. Prepare for Audit: Conduct internal checks and ensure compliance.
8. Resolve Queries Promptly: Maintain active communication with authorities.

By following these actionable steps and leveraging our expertise, manufacturers and importers can confidently pursue their CDSCO licensing for Distractor/Retractors, ensuring compliance and timely market access.

For detailed assistance tailored to your product, reach out to our regulatory consultants today and take the first step towards successful CDSCO licensing.