CDSCO License for Retracting and Exposing Surgical instruments

Comprehensive Guide to CDSCO Licensing for Retracting and Exposing Surgical Instruments (Class A)

Retracting and exposing surgical instruments are critical transient-use invasive surgical tools designed to hold back organs, tissues, and other articles during operative procedures. Their primary function is to provide surgeons with clear access by spreading open skin, ribs, and tissues or separating edges of surgical incisions. Given their invasive nature and essential role in surgeries, obtaining proper regulatory approval from the Central Drugs Standard Control Organization (CDSCO) in India is mandatory to ensure compliance, safety, and market access.

With over 25 years of experience helping more than 500 manufacturers and importers successfully navigate the CDSCO licensing landscape, we provide you with an expert, step-by-step guide tailored specifically for Class A surgical instruments like retractors and exposers.

CDSCO Regulatory Framework for Retracting and Exposing Surgical Instruments

The CDSCO regulates all medical devices under the Medical Device Rules (MDR) 2017, amended periodically to align with global best practices. Retracting and exposing surgical instruments fall under the category of Class A (low-risk) medical devices, classified as transient use invasive instruments. The governing notification for these devices is F. No. 29/Misc./03/2022-DC (228), dated 9.9.2022, which defines the scope and regulatory requirements.

Manufacturers and importers must comply with the MDR provisions, including quality management systems, testing, labeling, and licensing prior to marketing these devices in India.

Risk Classification and License Requirements for Retracting and Exposing Surgical Instruments

Under the CDSCO classification system, your device is categorized as Class A, which is the lowest risk category. This designation significantly simplifies the regulatory process and places licensing authority with the State Licensing Authority.

For Class A devices like retractors, the applicable manufacturing license is the MD5 License, which involves an audit by a notified body and submission of key technical and quality documents.

If you plan to import these devices, an MD15 Import License from the Central Licensing Authority is required.

For a detailed understanding of device classification, you can refer to our Medical Device Classification guide.

Manufacturing License Process for Class A Devices (MD5 License)

Obtaining an MD5 license involves a structured process with multiple steps:

1. Test License (Form MD13): Before applying for manufacturing license, you need a test license to conduct product testing in government-approved labs. This takes approximately 1.5 to 2 months.

2. Product Testing: Get your retracting and exposing instruments tested at CDSCO-recognized laboratories. Refer to the List of Testing Laboratories for approved facilities.

3. Document Preparation: Prepare comprehensive documentation including Device Master File, Plant Master File, Risk Management File, and Quality Management System documents.

4. License Application (Form MD3): Submit the MD5 manufacturing license application through the CDSCO MD Online Portal for State Licensing Authority approval.

5. Audit by Notified Body: A notified body will audit your manufacturing facility for compliance. You can check the List of Notified Bodies authorized for MD5 audits.

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

7. Grant of License (Form MD5): Upon successful audit and document verification, the MD5 manufacturing license is granted.

For a detailed walkthrough, see our MD5 License Guide.

Manufacturing License Documents Required for Retracting and Exposing Surgical Instruments

To ensure a smooth application process, gather the following documents:

• Company Constitution Documents: Incorporation certificate, partnership deed, etc.
• Proof of Ownership or Lease of Manufacturing Premises: Rent agreement or property documents.
• Details of Technical Staff: Qualification and experience certificates of key personnel.
• No Objection Certificates (NOCs): Fire safety and pollution control clearances.
• Device Master File (DMF): Detailed description of design, manufacturing processes, and specifications. Our Device Master File Guide can assist you.
• Plant Master File (PMF): Information on manufacturing site and quality controls. Learn how to prepare yours in our Plant Master File Guide.
• Essential Principles Checklist: Compliance to medical device safety and performance requirements.
• Risk Management File: Documented risk analysis and mitigation strategies. Read more at our Risk Management page.
• Test Reports: From CDSCO-recognized laboratories.
• Labels and Instructions for Use (IFU): Labeling per MDR requirements.
• Quality Management System Documentation: ISO 13485:2016 certification and standard operating procedures.

Import License Process (MD15) for Retracting and Exposing Surgical Instruments

If you intend to import retracting and exposing surgical instruments, an MD15 Import License must be obtained from the Central Licensing Authority. The process is as follows:

1. Document Preparation: Collect necessary documents including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016, CE Certificate, Device and Plant Master Files, wholesale license, and company constitution.

2. License Application (Form MD14): Submit your application through the CDSCO MD Online Portal.

3. Query Resolution: Respond to any clarifications requested by CDSCO.

4. Grant of License (Form MD15): After review, the import license is granted.

The import license process typically takes 5 to 6 months depending on document completeness and query resolution.

For detailed guidance, refer to our Import License Guide.

Import License Documents Required

Prepare the following documents for MD15 application:

• Valid Manufacturing License from the country of origin
• Free Sale Certificate
• ISO 13485:2016 Certificate
• CE Certificate (if applicable)
• Device Master File
• Plant Master File
• Wholesale License
• Company Constitution Documents
• Product Labels and IFU

Timeline and Processing Duration

Government Fees and Costs

For Class A surgical instruments, the following fees apply:

• MD5 Manufacturing License: Rs 5,000 per application + Rs 500 per product
• Test License (MD13): Included in application process
• Audit Fees: Payable to notified body separately (varies, typically INR 50,000 to 1,00,000)
• MD15 Import License:
  • Rs 1,000 per site
  • Rs 50 per product

Budgeting for notified body audits and testing laboratory charges is crucial for accurate cost estimation.

Common Challenges and Solutions

Challenge 1: Delays in Testing and Audit

Solution: Pre-schedule testing and audit appointments early and maintain constant communication with notified bodies and labs.

Challenge 2: Incomplete Documentation

Solution: Use checklists and expert consultations to ensure all documents, especially Device and Plant Master Files, are complete and compliant.

Challenge 3: Query Resolution Delays

Solution: Assign a dedicated regulatory liaison to respond promptly to CDSCO queries to avoid unnecessary delays.

Challenge 4: Understanding MDR Compliance

Solution: Invest in risk management and QMS training and leverage expert guidance to maintain compliance.

Expert Consultation and Support

Navigating CDSCO regulations can be complex. Our experience with over 500 successful CDSCO license applications for medical devices like retracting and exposing surgical instruments makes us your trusted partner. We offer:

• Comprehensive document preparation
• Liaison with notified bodies and testing labs
• Audit readiness support
• Query handling and application follow-up

Partnering with an expert consultant minimizes risks, accelerates approval timelines, and ensures regulatory compliance.

Getting Started with Your CDSCO License Application

1. Assess Your Device Classification: Confirm your device as Class A under the latest CDSCO notification.
2. Prepare Required Documentation: Begin compiling your Device Master File, Plant Master File, and Risk Management File.
3. Apply for Test License (Form MD13): Submit via the CDSCO MD Online Portal.
4. Plan Product Testing: Coordinate with CDSCO-approved labs early.
5. Schedule Notified Body Audit: Identify and contact a notified body from the official list.
6. Submit Manufacturing License Application (Form MD3): Once testing and documentation are complete.

By following these actionable steps and leveraging expert support, manufacturers and importers of retracting and exposing surgical instruments can confidently enter the Indian market with full regulatory compliance.

For personalized assistance and to streamline your CDSCO licensing journey, contact us today.