CDSCO License for Sterile Blood vessel surgical stripper
Medical Device Information
Intended Use
A surgical instrument used for complete or partial vascular resection.
Comprehensive CDSCO Licensing Guide for Sterile Blood Vessel Surgical Stripper (Class B Device)
As a specialized surgical instrument used for complete or partial vascular resection, the Sterile Blood Vessel Surgical Stripper falls under the Class B risk category. Proper regulatory compliance with the Central Drugs Standard Control Organization (CDSCO) is mandatory to manufacture or market this device in India. With over 25 years of experience and having assisted 500+ manufacturers and importers, we provide you with a detailed, step-by-step guide to navigate the CDSCO licensing process smoothly and efficiently.
Understanding the Device and Regulatory Importance
The Sterile Blood Vessel Surgical Stripper is a critical operation theatre device designed for vascular surgeries. Given its direct contact with the vascular system and potential impact on patient safety, CDSCO classifies it as a Class B device, requiring stringent controls to ensure safety, performance, and quality.
Failing to obtain the appropriate CDSCO license can lead to penalties, product recalls, or an outright ban on sales. Therefore, understanding the regulatory framework and preparing well in advance is vital for timely market access.
CDSCO Regulatory Framework for Sterile Blood Vessel Surgical Stripper
This device is regulated under the Medical Device Rules, 2017 (MDR 2017), enforced by CDSCO. Since it falls under Class B, the licensing authority is the State Licensing Authority, and the applicable manufacturing license is the MD5 license (Application Form MD3).
For imports, the license required is the MD15 license granted by the Central Licensing Authority.
To initiate any application, manufacturers and importers must utilize the CDSCO MD Online Portal for submission and tracking.
Risk Classification and License Requirements
- Device Name: Sterile Blood Vessel Surgical Stripper
- Risk Class: B (Low Moderate Risk)
- License Type: MD5 License for manufacturing (State Authority)
- Application Form: MD3 for MD5 license
- Notification: File No. 29/Misc/03/2020-DC (199)
- Notification Date: 13.9.2021
The Class B classification means the device requires a detailed audit from a notified body and adherence to essential principles of safety and performance.
Manufacturing License Process (MD5)
The manufacturing license process for Class B devices like the Sterile Blood Vessel Surgical Stripper involves several critical steps:
Apply for Test License (Form MD13): Before the full license, obtain a test license to manufacture limited quantities for testing purposes. This typically takes 1.5 to 2 months.
Product Testing: Conduct product testing at CDSCO-approved laboratories. Refer to the Testing Laboratories list for government-recognized labs. Testing ensures compliance with Indian standards and essential principles.
Documentation Preparation: Assemble all required documents, including quality management system (QMS), risk management, and device master files.
Submit Manufacturing License Application (Form MD3): File the MD5 license application via the CDSCO portal.
Notified Body Audit: A notified body will conduct an audit of your manufacturing facility and QMS. Consult the list of notified bodies to select an appropriate auditor.
Queries and Clarifications: Address any queries raised by CDSCO or the notified body promptly to avoid delays.
License Grant: Upon successful audit and document verification, the MD5 license is granted.
For an in-depth understanding, our MD5 License Guide offers detailed insights.
Manufacturing License Documents Required
The comprehensive documentation package for the Sterile Blood Vessel Surgical Stripper’s MD5 license includes:
- Company Constitution Documents (e.g., memorandum of association, partnership deed)
- Proof of Ownership or Lease Agreement of Manufacturing Premises
- Details and Qualifications of Technical Staff
- Fire NOC and Pollution Control Board NOC
- Device Master File (DMF) detailing device specifications and manufacturing processes (Device Master File Guide)
- Plant Master File describing the manufacturing site and quality systems (Plant Master File Guide)
- Essential Principles Checklist ensuring compliance with MDR 2017
- Risk Management File detailing risk analysis and mitigation strategies (Risk Management Guide)
- Product Test Reports from CDSCO-approved labs
- Device Labels and Instructions for Use (IFU)
- Quality Management System (QMS) Documents, preferably ISO 13485:2016 certification
Maintaining meticulous and organized documentation accelerates application review and demonstrates your commitment to quality.
Import License Process (MD15)
If you are an importer of the Sterile Blood Vessel Surgical Stripper, the applicable license is the MD15 license, granted by the Central Licensing Authority.
Key steps include:
Documentation Preparation: Collect all essential documents such as manufacturing license from the country of origin, Free Sale Certificate, ISO certification, CE certificate, Device and Plant Master Files, and wholesale license.
Submit Application (Form MD14): Apply through the CDSCO MD Online Portal.
Query Resolution: Promptly address any clarifications requested by CDSCO.
Grant of Import License: Upon successful review, the MD15 license is issued.
Refer to our Import License Guide for a detailed walkthrough.
Import License Documents Required
- Valid Manufacturing License of the foreign manufacturer
- Free Sale Certificate from country of origin
- ISO 13485:2016 Certification
- CE Certificate or equivalent
- Device Master File and Plant Master File
- Wholesale License in India
- Company Constitution Documents
Timeline and Processing Duration
| License Type | Timeline |
|---|---|
| Test License (MD13) | 1.5 to 2 months |
| Product Testing | 1 to 1.5 months (parallel with test license) |
| MD5 License (MD3) | 3 to 4 months (post testing and audit) |
| MD15 Import License | 5 to 6 months |
Overall, expect a total process time of approximately 3 to 4 months for manufacturing licenses, considering all steps from test license to final approval.
Government Fees and Costs
For the Sterile Blood Vessel Surgical Stripper (Class B), the fees are as follows:
MD5 License:
- Application Fee: Rs 5,000
- Per Product Fee: Rs 500
MD13 Test License: Included within MD5 process, no separate fee
MD15 Import License:
- Site Fee: $2,000 (approx Rs 1.5 lakh)
- Product Fee: $1,000 (approx Rs 75,000) per product
Note: Fees may vary slightly based on exchange rates and amendments. Budgeting in advance helps avoid surprises.
Common Challenges and Solutions
Delays in Product Testing: Testing labs often have backlogs. Plan testing early and select labs from the CDSCO-approved Testing Laboratories list to avoid bottlenecks.
Incomplete Documentation: Missing or inconsistent documents cause queries and rejections. Use comprehensive checklists and consult experts to ensure completeness.
Audit Non-Conformities: Non-compliance during notified body audits can delay approvals. Conduct internal pre-audits and train staff thoroughly.
Understanding Regulatory Updates: The medical device regulatory landscape evolves. Stay updated with CDSCO notifications and amendments.
Expert Consultation and Support
Navigating the CDSCO licensing process for a Class B device like the Sterile Blood Vessel Surgical Stripper requires expert knowledge and meticulous preparation. Our team has successfully assisted over 500 companies in obtaining MD5 and MD15 licenses, reducing approval timelines and minimizing risks.
Our services include:
- Gap assessment and documentation review
- Guidance on test license and product testing
- Coordination with notified bodies for audits
- Application preparation and submission on the CDSCO MD Online Portal
- Post-approval compliance support
Contact us early in your product development cycle to ensure a smooth regulatory journey.
Getting Started with Your CDSCO License Application
To initiate your CDSCO licensing process for the Sterile Blood Vessel Surgical Stripper, follow these practical steps:
Verify Device Classification: Confirm Class B classification and eligibility for MD5 license.
Prepare Documentation: Assemble all required documents including DMF, PMF, risk management files, and quality system certifications.
Apply for Test License (MD13): Submit your test license application through the CDSCO MD Online Portal to begin manufacturing samples for testing.
Schedule Product Testing: Book slots at government-approved testing labs early to avoid delays.
Engage a Notified Body: Contact an appropriate notified body for the required audit; schedule the audit post-testing.
Submit MD5 Application (Form MD3): After successful testing and audit, submit the manufacturing license application online.
Monitor Application Progress: Regularly check for queries on the portal and respond promptly.
License Grant and Market Launch: Once the MD5 license is granted, you can legally manufacture and market your Sterile Blood Vessel Surgical Stripper in India.
By following these steps and leveraging experienced consultancy, you can reduce the typical 3-4 month processing time and avoid common pitfalls.
We recommend starting your application process well before your planned market launch to accommodate any unforeseen delays.
For tailored assistance and to discuss your specific project requirements, reach out to our regulatory experts today. Our proven track record and in-depth knowledge make us your trusted partner in CDSCO licensing for medical devices.
