CDSCO License for Non-sterile Blood vessel surgical  stripper

Comprehensive Guide to CDSCO Licensing for Non-Sterile Blood Vessel Surgical Stripper (Class A Device)

Navigating the regulatory landscape for medical devices in India can be complex, especially for manufacturers and importers aiming to market specialized products like the non-sterile blood vessel surgical stripper. This surgical instrument, intended for complete or partial vascular resection, falls under Class A risk category and is categorized under Operation Theatre devices. With the CDSCO notification File No. 29/Misc/03/2020-DC (199) dated 13.9.2021, compliance with India's regulatory framework is mandatory for legal market entry.

At our consultancy, having supported over 500 companies successfully secure CDSCO licenses, we provide precise, actionable insights tailored to your device type and risk class to streamline your approval journey.

CDSCO Regulatory Framework for Non-Sterile Blood Vessel Surgical Stripper

The Central Drugs Standard Control Organization (CDSCO) governs the import, manufacture, and sale of medical devices in India. Devices like the non-sterile blood vessel surgical stripper are regulated under the Medical Device Rules (MDR) 2017, which classify devices based on risk and intended use.

For this Class A device, the regulatory oversight is primarily managed by the State Licensing Authority through the MD5 manufacturing license process, ensuring compliance with safety, quality, and performance standards.

Manufacturers must engage in a structured application process on the CDSCO MD Online Portal to obtain the necessary licenses before commencing operations.

Risk Classification and License Requirements

The non-sterile blood vessel surgical stripper is classified as a Class A device—the lowest risk category under CDSCO guidelines. Class A devices require an MD5 manufacturing license, issued by the State Licensing Authority.

Key points regarding Class A devices and license requirements:

• License Type: MD5 License (Application Form MD3)
• Authority: State Licensing Authority
• Timeline: Approximately 3-4 months (including test license and audit)
• Fees: Rs 5,000 per application plus Rs 500 per product

This device's risk classification demands adherence to essential principles of safety and performance but involves a less rigorous process compared to higher-risk classes.

For detailed classification guidelines, refer to our Medical Device Classification resource.

Manufacturing License Process (MD5) for Class A Devices

The MD5 license issuance process involves multiple stages designed to verify both product quality and manufacturing site compliance:

1. Test License Application (Form MD13): Obtain a test license to legally manufacture the device for testing purposes. This step typically takes 1.5 to 2 months.

2. Product Testing: Submit samples to CDSCO-approved testing laboratories for compliance verification.

3. Document Preparation: Compile required documents, including Device Master File, Plant Master File, Quality Management System (QMS) documentation, and risk management files.

4. License Application (Form MD3): Apply for the manufacturing license through the MD Online Portal.

5. Audit by Notified Body: A notified body conducts an on-site audit to assess manufacturing compliance. Find the list of notified bodies authorized for the MD5 audit.

6. Query Resolution: Address any queries or deficiencies identified by the licensing authority or notified body.

7. Grant of MD5 License: Upon satisfactory compliance, the license is issued in Form MD5.

Our comprehensive MD5 License Guide offers detailed insights into each step.

Manufacturing License Documents Required for Non-Sterile Blood Vessel Surgical Stripper

Preparing a thorough documentation package is critical for a smooth licensing process. For your Class A device, the following documents are essential:

• Company Constitution (e.g., Memorandum and Articles of Association)
• Proof of Ownership or Lease of Manufacturing Premises
• Technical Staff Details: Qualifications and experience of key personnel
• No Objection Certificates (NOC): Fire safety and pollution control clearances
• Device Master File (DMF): Detailed product specifications, design, and manufacturing processes (Device Master File Guide)
• Plant Master File (PMF): Overview of manufacturing facility and processes (Plant Master File Guide)
• Essential Principles Checklist: Compliance with safety and performance standards
• Risk Management File: Hazard analysis and mitigation strategies (Risk Management Guide)
• Test Reports: Certification from CDSCO-approved labs
• Labels and Instructions for Use (IFU): Product labeling, user manuals
• Quality Management System Documentation: ISO 13485 certification and related SOPs

Attention to detail in documentation reduces the likelihood of delays caused by incomplete or inconsistent information.

Import License Process (MD15) for Non-Sterile Blood Vessel Surgical Stripper

While this guide primarily addresses manufacturing licenses for Class A devices, importers intending to bring the non-sterile blood vessel surgical stripper into India require an MD15 import license issued by the Central Licensing Authority.

Key highlights of the import license process:

• Application Form: MD14
• Timeline: Approximately 5-6 months
• Fees: Varies by class and product quantity; for Class A devices, typically $1000 per site plus$50 per product
• Documents Required: Valid manufacturing license from country of origin, Free Sale Certificate, ISO 13485:2016, CE Certificate (if applicable), Device Master File, Plant Master File, Wholesale license, and Company Constitution

For an in-depth breakdown, consult our Import License Guide.

Timeline and Processing Duration

For the non-sterile blood vessel surgical stripper (Class A), expect the following indicative timelines:

Proactive planning and submission of complete documents can help maintain or shorten these timelines.

Government Fees and Costs

The fee structure for MD5 licenses for Class A devices is as follows:

• Application Fee: Rs 5,000 per application
• Per Product Fee: Rs 500 per product

Additional costs to consider:

• Testing laboratory fees (varies by product and tests required)
• Notified body audit charges
• Consultancy fees if engaging expert support

Budgeting for these expenses upfront aids smoother financial planning.

Common Challenges and Solutions

Challenge 1: Delays due to incomplete documentation

Solution: Use detailed checklists and cross-verify documents against CDSCO requirements. Our Device and Plant Master File guides can ensure completeness.

Challenge 2: Audit non-compliance

Solution: Conduct internal pre-audits and gap analyses to identify areas of improvement before the notified body visit.

Challenge 3: Prolonged query resolution

Solution: Maintain clear communication with CDSCO authorities and respond promptly with substantiated evidence.

Challenge 4: Difficulty in product testing

Solution: Choose government-approved testing laboratories with experience in similar surgical instruments.

Expert Consultation and Support

With 25+ years helping over 500 companies navigate CDSCO licensing, we offer end-to-end support—from documentation review to audit preparation and post-licensing compliance. Our expertise ensures your non-sterile blood vessel surgical stripper meets all regulatory expectations efficiently.

Getting Started with Your CDSCO License Application

If you are ready to enter the Indian market with your non-sterile blood vessel surgical stripper, here are practical next steps:

1. Register on the CDSCO MD Online Portal to access application forms and submit your dossiers.

2. Apply for the Test License (Form MD13) to begin initial manufacturing and testing.

3. Engage a CDSCO-approved testing laboratory early to schedule product testing.

4. Prepare comprehensive documentation — leverage our Device Master File and Plant Master File guides.

5. Schedule a notified body audit and conduct internal pre-audits to ensure readiness.

6. Submit your MD5 license application (Form MD3) after successful testing and audit.

7. Respond promptly to any queries from CDSCO or the notified body.

By following these steps and leveraging expert guidance, you can significantly enhance your chances of obtaining the MD5 manufacturing license for your Class A non-sterile blood vessel surgical stripper within 3 to 4 months.

We invite you to connect with us for personalized assistance tailored to your product and business needs.