CDSCO License for Endoscopic motorized cutting stapler, reusable

Comprehensive Guide to CDSCO Licensing for Endoscopic Motorized Cutting Stapler (Reusable) – Class B Medical Device

As a trusted regulatory consulting firm with over 25 years of expertise and a track record of supporting 500+ companies, we understand the intricacies involved in securing CDSCO approvals for innovative medical devices like the Endoscopic Motorized Cutting Stapler (reusable). This device, classified under risk Class B, holds critical importance in gastroenterology, enabling precise tissue transection and anastomosis during endoscopic surgeries. Navigating India’s regulatory framework efficiently can accelerate your market entry and compliance posture.

CDSCO Regulatory Framework for Endoscopic Motorized Cutting Stapler

The Central Drugs Standard Control Organization (CDSCO) oversees the regulation of medical devices in India under the Medical Device Rules, 2017, aligned with the Drugs and Cosmetics Act. Your device is notified under Notification No. 29/Misc./03/2020-DC (182) dated 27.09.2021, categorizing it as a Class B device due to its moderate risk profile.

This classification mandates a specific licensing pathway and adherence to quality and safety norms before manufacturing or import can commence.

Risk Classification and License Requirements for Class B Device

The Endoscopic Motorized Cutting Stapler falls under Class B. According to CDSCO:

• Manufacturing License: MD5 License (Application Form MD3) issued by the State Licensing Authority.
• Import License: MD15 License issued by the Central Licensing Authority.

Given that this is a reusable surgical instrument with electronic components, rigorous evaluation of technical and safety parameters is essential.

Manufacturing License Process (MD5) for Class B Devices

Obtaining the MD5 manufacturing license involves a multi-step process designed to ensure compliance:

1. Obtain Test License (Form MD13): This preliminary step allows sample testing and takes approximately 1.5 to 2 months.
2. Product Testing: Conduct testing at CDSCO-recognized government laboratories. You can identify suitable testing centers from the official list of testing laboratories.
3. Documentation Preparation: Compile comprehensive technical documentation including Device Master File and Plant Master File.
4. Application Submission: File your application on the CDSCO MD Online Portal using Form MD3.
5. Audit by Notified Body: A mandatory audit by notified bodies ensures your manufacturing facility complies with regulatory requirements. Refer to the list of notified bodies for audit selection.
6. Query Resolution: Address any observations raised by CDSCO or the notified body.
7. License Grant: Upon satisfactory completion, the license is granted on Form MD5.

Manufacturing License Documents Required for MD5

Successful applications require thorough documentation. For your Endoscopic Motorized Cutting Stapler, ensure the following are prepared meticulously:

• Company Constitution and Incorporation documents
• Proof of ownership or valid lease agreement of manufacturing premises
• Qualification and experience certificates of technical staff
• Fire and Pollution NOCs
• Device Master File (DMF): Detailed design, manufacturing, and safety information. Our Device Master File guide offers essential tips for preparation.
• Plant Master File (PMF): Details on manufacturing facility, infrastructure, and quality systems. See our Plant Master File guide for insights.
• Essential Principles Checklist confirming compliance with Indian Medical Device Rules
• Risk Management File detailing hazard analysis and mitigation strategies, crucial for devices with electrical and reusable components. Learn more about Risk Management.
• Product Test Reports from government-approved labs
• Labels and Instructions for Use (IFU), compliant with CDSCO labeling guidelines
• Quality Management System (QMS) documentation, preferably ISO 13485:2016 certified

Import License Process (MD15) for Class B Devices

For importers of the Endoscopic Motorized Cutting Stapler, the MD15 license is essential. The process is as follows:

1. Documentation Preparation: Collect all necessary documents including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016 certification, CE certificate if applicable, and technical dossiers.
2. Application Submission: Submit Form MD14 on the CDSCO MD Online Portal.
3. Query Resolution: Address department queries promptly.
4. License Grant: MD15 license is issued after thorough review.

Unlike manufacturing, import licensing does not require a test license but demands robust documentation.

Import License Documents Required

Key documents include:

• Manufacturing License of the device from the country of origin
• Free Sale Certificate indicating the device is legally sold in the country of origin
• ISO 13485:2016 certification
• CE Certificate or equivalent
• Device Master File and Plant Master File
• Wholesale Drug License (for distribution)
• Company Constitution and registration documents

Timeline and Processing Duration for Class B Device Licensing

• MD5 Manufacturing License: Approximately 3-4 months total.

  • Test license (MD13): 1.5 – 2 months
  • Product testing & documentation: 2-3 weeks
  • Audit and query resolution: 4-6 weeks

• MD15 Import License: Approximately 5-6 months due to detailed documentation verification.

Government Fees and Costs

For MD5 manufacturing license:

• Application fee: ₹5,000 per application
• Product fee: ₹500 per product (for your Endoscopic Motorized Cutting Stapler, each variant counts as a product)

For MD15 import license:

• Class B Fees: $2,000 per site and$1,000 per product. Fees are payable in USD as per the latest exchange rates.

Common Challenges and Practical Solutions

• Delayed Testing Approvals: Lab slots at government-approved centers can be limited. Early booking and following up with labs can expedite this.
• Incomplete Documentation: Missing or inconsistent documents cause rejections. Use detailed checklists and professional document management.
• Audit Non-compliance: Facilities not meeting GMP or QMS standards fail audits. Conduct internal pre-audits and staff training to ensure readiness.
• Query Delays: Slow responses to CDSCO queries prolong timelines. Assign dedicated personnel for timely communication.

Expert Consultation and Support

Our seasoned experts provide end-to-end assistance from gap analysis, document preparation, audit coordination to query handling. Leveraging our experience, we help you navigate complexities, reduce approval times, and avoid common pitfalls.

Getting Started with Your CDSCO License Application

1. Assess your Device Classification and Regulatory Pathway: Confirm your device’s Class B status and related license form (MD3 for manufacturing).
2. Initiate Test License Application: File Form MD13 on the CDSCO MD Online Portal to gain authorization for product testing.
3. Engage Government Testing Laboratories: Submit device samples promptly to approved labs for testing.
4. Prepare Core Documentation: Develop your Device Master File, Plant Master File, Risk Management and QMS documents meticulously.
5. Schedule Notified Body Audit: Contact notified bodies early to align audit timelines with your application process.
6. Submit Manufacturing License Application: Complete Form MD3 with all supporting documents and apply via the CDSCO portal.
7. Monitor Application Progress: Respond swiftly to any queries or requests from CDSCO or auditors.

Embarking on your CDSCO licensing journey with a clear, structured approach saves time and resources. Our dedicated team is ready to assist you at every stage to bring your Endoscopic Motorized Cutting Stapler to the Indian market compliantly and efficiently.

For personalized guidance and support, connect with us today and leverage our deep regulatory expertise to ensure your success in India’s dynamic medical device landscape.