CDSCO License for Neurological stereotactic surgery system
Medical Device Information
Intended Use
Intended to store diagnostic images used for image-guided neurosurgery.
Comprehensive Guide to CDSCO Licensing for Neurological Stereotactic Surgery Systems
Neurological stereotactic surgery systems play a critical role in image-guided neurosurgery by storing diagnostic images that assist surgeons in precise interventions. Given their high-risk nature and significant impact on patient safety, regulatory compliance is paramount. As specialists with over 25 years of experience assisting 500+ companies, we understand the complexities involved in securing your CDSCO license efficiently and effectively.
CDSCO Regulatory Framework for Neurological Stereotactic Surgery Systems
Neurological stereotactic surgery systems fall under the category of neurological medical devices as per CDSCO's device classification. According to the notification 29/Misc/03/2020-DC (201), published on 27.09.2021, this device is classified as Class C—indicating a high moderate risk requiring strict regulatory oversight.
The Central Drugs Standard Control Organization (CDSCO) regulates these devices under the Medical Device Rules 2017 (MDR 2017), ensuring quality, safety, and efficacy before market entry.
Risk Classification and License Requirements
Class C devices like the neurological stereotactic surgery system require a Manufacturing License MD9 issued by the Central Licensing Authority. The MD9 license application process is more rigorous due to the device's risk profile and involves:
- Obtaining a test license (Form MD13) initially
- Product testing at CDSCO-approved laboratories
- Detailed documentation and Quality Management System (QMS) compliance
- Audits by CDSCO inspectors
For importers, an Import License MD15 issued by the Central Licensing Authority is mandatory to bring these devices into India.
Manufacturing License Process (MD9)
Our step-by-step approach for obtaining the MD9 license for your neurological stereotactic surgery system is as follows:
Apply for Test License (Form MD13): This license allows you to produce a limited quantity for testing purposes. The process typically takes 1.5 to 2 months.
Product Testing: Conduct mandatory testing at government-approved labs listed on the CDSCO portal. These tests validate compliance with Indian standards.
Documentation Preparation: Assemble comprehensive documents including Device Master File, Plant Master File, Risk Management File, Essential Principles Checklist, and QMS documentation.
Apply for Manufacturing License (Form MD7): Submit your complete application via the CDSCO MD Online Portal.
CDSCO Audit: Central licensing authorities will conduct a thorough inspection of your manufacturing facility and documentation.
Query Resolution: Address any observations raised by the CDSCO inspectors promptly.
License Grant: Upon satisfactory compliance, the MD9 license is granted.
Manufacturing License Documents Required
To ensure a smooth application process, prepare the following documents meticulously:
- Company constitution (Incorporation certificate, MOA, AOA)
- Proof of ownership/lease of manufacturing premises
- Technical staff qualification and experience proof
- Fire NOC and Pollution Control Board NOC
- Device Master File (DMF): Detailed design, manufacturing process, and validation data. Our Device Master File guide can help streamline this.
- Plant Master File (PMF): Details on manufacturing facility, equipment, and quality control measures. Refer to our Plant Master File guide.
- Essential Principles Checklist confirming conformance to safety and performance standards
- Risk Management File as per ISO 14971 requirements (Learn more about risk management here)
- Test reports from CDSCO-approved laboratories
- Labels and Instructions for Use (IFU)
- Quality Management System documents (ISO 13485 certification is highly recommended)
Import License Process (MD15)
For companies importing neurological stereotactic surgery systems, the MD15 import license issued by the Central Licensing Authority is mandatory. The process involves:
Document preparation: Includes manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016 certificate, CE certificate, Device and Plant Master Files, Wholesale license in India, and company constitution.
Application submission: Submit Form MD14 via the CDSCO MD Online Portal.
Query resolution: Address any CDSCO queries promptly.
License grant: Typically completed in 5-6 months.
Import License Documents Required
Key documents for import license application include:
- Valid foreign manufacturing license
- Free Sale Certificate from the country of origin
- ISO 13485:2016 certification
- CE Certificate (for European conformity)
- Device Master File and Plant Master File
- Wholesale Drug License in India
- Company constitution and ownership proof
Timeline and Processing Duration
For your neurological stereotactic surgery system (Class C device), expect the following timelines:
| Process Stage | Duration |
|---|---|
| Test License (MD13) | 1.5 - 2 months |
| Product Testing | 1 - 1.5 months |
| Documentation Prep | 1 month |
| Manufacturing License (MD9) Application | 1.5 - 2 months (including audit and query resolution) |
| Total Estimated Time | 4 - 5 months |
Import license processing for MD15 generally takes 5-6 months.
Government Fees and Costs
The CDSCO fee structure for Class C devices is as follows:
- MD9 Manufacturing License: Rs. 50,000 per application + Rs. 1,000 per product
- MD13 Test License: Separate application fee (usually nominal, check latest portal updates)
- MD15 Import License Fees:
- Rs. 300,000 per site
- Rs. 150,000 per product
These fees are payable via the CDSCO MD Online Portal.
Common Challenges and Solutions
Challenge 1: Delays in product testing due to lab backlogs
- Solution: Choose CDSCO-approved labs carefully from the official list and submit samples early.
Challenge 2: Incomplete or inconsistent documentation
- Solution: Use checklists and templates for Device Master File and Plant Master File. Our guides offer detailed frameworks to avoid common pitfalls.
Challenge 3: Audit non-compliance issues
- Solution: Conduct internal pre-audits and ensure your QMS aligns with ISO 13485 standards.
Challenge 4: Query resolution delays
- Solution: Assign a dedicated regulatory coordinator to respond promptly and comprehensively to CDSCO queries.
Expert Consultation and Support
With our 25+ years of expertise and over 500 successful CDSCO license approvals, we provide tailored consultancy services including:
- End-to-end license application management
- Documentation drafting and review
- Pre-audit readiness assessments
- Regulatory updates and compliance training
Our proactive approach reduces approval timelines and accelerates market entry.
Getting Started with Your CDSCO License Application
Assess your device classification: Confirm Class C status via the Medical Device Classification tool.
Prepare your test license application: Gather initial documents and apply for Form MD13 on the CDSCO MD Online Portal.
Identify CDSCO-approved testing labs: Select a lab from the official list and initiate product testing.
Develop comprehensive Device and Plant Master Files: Utilize our expert guides to create robust documentation.
Plan for audit readiness: Align your QMS and manufacturing processes per requirements.
Submit your manufacturing license application (MD9): Upload all documents and track application status online.
Embarking on this regulatory journey with the right knowledge and support ensures your neurological stereotactic surgery system reaches Indian patients safely and compliantly. Contact us today to leverage our expertise and streamline your CDSCO licensing process.
