CDSCO License for Peripheral Stent System
Medical Device Information
Intended Use
A Peripheral stent is a tube-shaped device placed in the peripheralarteries that supply blood into body organ.
Peripheral Stent System: Comprehensive Guide to CDSCO Licensing for Class C Medical Devices
Peripheral Stent Systems are critical catheter-based medical devices designed to restore and maintain blood flow in peripheral arteries supplying vital organs. Given their invasive nature and patient safety implications, they are rigorously regulated under India's CDSCO framework as Class C devices. For manufacturers and importers aiming to enter the Indian market, obtaining the correct CDSCO licenses is mandatory and requires detailed preparation, documentation, and compliance.
With over 25 years of combined experience assisting 500+ companies, we provide expert insights and practical guidance tailored specifically for Peripheral Stent Systems under CDSCO Notification 29/Misc/3/2017-DC (292), dated 06.06.2018.
CDSCO Regulatory Framework for Peripheral Stent Systems
The Central Drugs Standard Control Organization (CDSCO) governs the import, manufacture, and sale of medical devices in India. Peripheral Stent Systems fall under the Catheters category and are classified as Class C devices due to their medium to high risk profile.
Class C classification means the device has a significant impact on patient health and requires strict regulatory scrutiny before market approval. This classification mandates compliance with the Medical Device Rules, 2017, and relevant CDSCO notifications.
Risk Classification and License Requirements for Peripheral Stent Systems
Peripheral Stent Systems are designated as Class C devices because they are invasive and implantable devices with moderate risk. This classification requires manufacturers to obtain an MD9 Manufacturing License issued by the Central Licensing Authority, while importers must secure an MD15 Import License.
The regulatory pathway involves:
- MD9 License (Manufacturing): For Indian manufacturers.
- MD15 License (Import): For foreign manufacturers or Indian importers.
Each license type has specific application forms, documentation, timelines, and fees detailed below.
Manufacturing License Process for Peripheral Stent Systems (MD9)
Step 1: Obtain Test License (Form MD13)
Before applying for an MD9 manufacturing license, you must secure a Test License (MD13) to legally manufacture the device for testing purposes. This process typically takes 1.5 to 2 months.
Step 2: Product Testing
The Peripheral Stent System must undergo mandatory testing at CDSCO-approved laboratories. Testing typically covers biocompatibility, mechanical integrity, sterility, and other relevant parameters. Refer to the list of testing laboratories for approved facilities.
Step 3: Documentation Preparation
Compile comprehensive documentation including Company Constitution, Proof of Ownership, Technical Staff Details, Fire and Pollution NOCs, Device Master File, Plant Master File, Essential Principles Checklist, Risk Management File, Test Reports, Labels, Instructions for Use (IFU), and Quality Management System (QMS) documents.
Our detailed Device Master File guide and Plant Master File guide can assist you in preparing these critical dossiers.
Step 4: Submit MD9 Application (Form MD7)
Apply online through the CDSCO MD Online Portal using Form MD7 for the MD9 license.
Step 5: CDSCO Inspection and Audit
After submitting your application, CDSCO inspectors will audit your manufacturing site and documentation to verify compliance.
Step 6: Query Resolution
Respond promptly and comprehensively to any queries raised by CDSCO or the notified bodies.
Step 7: Grant of License (Form MD9)
Upon satisfactory audit and document review, CDSCO will grant the MD9 license allowing manufacturing and sale of Peripheral Stent Systems in India.
For a deeper dive into this process, see our MD9 License Guide.
Manufacturing License Documents Required for Peripheral Stent Systems
- Company Constitution (Incorporation Certificate, MOA/AOA)
- Proof of Ownership or Lease Agreement of Manufacturing Premises
- Technical Staff Qualification and Experience Proof
- Fire NOC from local authorities
- Pollution Control Board NOC
- Device Master File (DMF)
- Plant Master File (PMF)
- Essential Principles Compliance Checklist
- Risk Management File (per ISO 14971)
- Test Reports from CDSCO-approved labs
- Product Labels and Packaging
- Instructions for Use (IFU)
- Quality Management System Documents (ISO 13485:2016)
Import License Process for Peripheral Stent Systems (MD15)
Step 1: Document Compilation
Prepare essential documents including your current Manufacturing License from the country of origin, Free Sale Certificate, ISO 13485:2016 certification, CE Certificate (if applicable), Device Master File, Plant Master File, Wholesale License, and Company Constitution.
Step 2: Application Submission
Apply for the MD15 Import License through the CDSCO MD Online Portal using Form MD14.
Step 3: Query Resolution
Address any queries from CDSCO expediently to avoid delays.
Step 4: License Grant
Upon review, CDSCO issues the MD15 license, authorizing import and sale in India.
For detailed guidance, refer to our Import License Guide.
Import License Documents Required
- 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
Timeline and Processing Duration
| License Type | Timeline |
|---|---|
| Test License (MD13) | 1.5 - 2 months |
| MD9 Manufacturing License | 4 - 5 months (including test license) |
| MD15 Import License | 5 - 6 months |
The timelines include document preparation, testing, audits, query resolution, and final approval. Delays often occur due to incomplete documentation or slow responses to queries.
Government Fees and Costs
| License Type | Application Fee | Per Product Fee |
|---|---|---|
| MD9 License (Class C) | Rs 50,000 | Rs 1,000 |
| MD15 Import License (Class C) | $3,000 USD (approx Rs 2.4 Lakhs) | $1,500 USD (approx Rs 1.2 Lakhs) |
Note: Test License fees and testing costs vary depending on the number and complexity of tests.
Common Challenges and Solutions
- Incomplete Documentation: Prepare checklists and use expert templates to ensure completeness.
- Delayed Testing Results: Schedule testing well in advance at CDSCO-approved labs.
- Non-compliance in Audits: Conduct internal mock audits to preempt findings.
- Query Resolution Delays: Assign dedicated regulatory personnel for prompt responses.
Expert Consultation and Support
With our proven track record supporting over 500 medical device companies, we offer tailored consultancy for:
- Device classification and regulatory strategy
- Preparation of Device and Plant Master Files
- Test license and product testing coordination
- Application preparation and submission on the CDSCO MD Online Portal
- Audit readiness and post-audit support
Getting Started with Your CDSCO License Application
- Assess Your Device Classification: Confirm Peripheral Stent System as Class C.
- Prepare Documentation: Leverage our Device Master File guide and Plant Master File guide to organize your technical files.
- Apply for Test License (MD13): Initiate test license application to manufacture samples for testing.
- Coordinate Product Testing: Select CDSCO-approved labs and plan testing timelines.
- Submit MD9 or MD15 Application: Use the CDSCO MD Online Portal for seamless submission.
- Prepare for Audit: Schedule audits with CDSCO inspectors and ensure compliance.
- Respond to Queries Promptly: Maintain swift communication with CDSCO.
By following these actionable steps and leveraging our expertise, you can significantly reduce approval times and successfully launch your Peripheral Stent System in the Indian market.
For personalized assistance, contact us to streamline your CDSCO licensing journey for Peripheral Stent Systems and related catheter devices.
