CDSCO License for Analgesic spinal cord electrical stimulation system

Comprehensive Guide to CDSCO Licensing for Analgesic Spinal Cord Electrical Stimulation Systems

As a specialized device designed for pain management, an Analgesic Spinal Cord Electrical Stimulation System falls under the Class C risk category as per CDSCO regulations. This system applies targeted electrical stimuli to the spinal cord to provide analgesia, making it a critical therapeutic device. Navigating the regulatory landscape in India is crucial for manufacturers and importers aiming to enter this lucrative market safely and compliantly.

With over 25 years of experience and having assisted 500+ companies in securing their CDSCO licenses, we provide you with a detailed, step-by-step guide tailored to this specific device type.

CDSCO Regulatory Framework for Analgesic Spinal Cord Electrical Stimulation Systems

The Central Drugs Standard Control Organization (CDSCO) regulates all medical devices in India under the Medical Device Rules, 2017. Your device is notified under File No. 29/Misc./03/2020-DC (178) dated 13.9.2021, placing it clearly under Class C, which dictates a stringent compliance framework.

Manufacturers and importers must comply with the regulatory requirements for quality, safety, and efficacy, which includes licensing, testing, documentation, and audits.

Risk Classification and License Requirements for Class C Devices

Class C devices, such as the spinal cord electrical stimulation system, are considered moderate-to-high risk. The licensing authority for manufacturing is the Central Licensing Authority, and the appropriate manufacturing license is the MD9 license, filed on Form MD7.

For importers, the license required is the MD15 import license, applied via Form MD14.

Understanding the classification and associated licensing process is critical to meeting CDSCO’s expectations and avoiding costly delays.

Manufacturing License Process (MD9) for Class C Devices

Step 1: Obtain Test License (MD13)

Before applying for the manufacturing license, a Test License under Form MD13 must be secured. This allows you to legally manufacture the device for testing purposes.

Timeline: Approximately 1.5 to 2 months

Step 2: Product Testing

Conduct mandatory product testing at CDSCO-approved government laboratories. Testing validates compliance with Indian standards and essential principles.

Refer to the List of Testing Laboratories for approved facilities.

Step 3: Documentation Preparation

Prepare comprehensive documents including Device Master File (DMF), Plant Master File (PMF), Risk Management File, and Quality Management System (QMS) documentation.

Our detailed Device Master File Guide can help streamline this step.

Step 4: Apply for MD9 Manufacturing License

Submit your application on the CDSCO MD Online Portal using Form MD7.

Step 5: CDSCO Audit and Inspection

CDSCO inspectors conduct a thorough audit of your manufacturing site and documentation.

You can consult the Notified Bodies List to familiarize yourself with authorized auditors.

Step 6: Query Resolution

Respond promptly to any queries or observations raised during the audit.

Step 7: License Granting

Upon satisfactory compliance, CDSCO issues the MD9 manufacturing license.

Manufacturing License Documents Required for MD9

Company Constitution (Incorporation Certificate, MoA, AoA)
Proof of Ownership or Lease of Manufacturing Premises
Details of Qualified Technical Staff (CVs, Certificates)
Fire NOC and Pollution Control Board NOC
Device Master File (DMF)
Plant Master File (PMF) Learn how to prepare one here
Essential Principles Checklist confirming compliance with Indian standards
Risk Management File outlining hazard analysis and mitigation strategies (Risk Management Guide)
Test Reports from government-approved labs
Product Labels and Instructions for Use (IFU)
Quality Management System documents (ISO 13485:2016 certification recommended)

Import License Process (MD15) for Class C Devices

Step 1: Document Preparation

Compile necessary documents including manufacturing license, ISO 13485 certificate, Free Sale Certificate, CE certificate, DMF, PMF, and wholesale license.

Step 2: Application Submission

Apply online via the CDSCO MD Online Portal using Form MD14 for the MD15 import license.

Step 3: Query Resolution

Address any department queries promptly.

Step 4: License Granting

The CDSCO Central Licensing Authority typically grants the MD15 import license after 5-6 months.

Import License Documents Required for MD15

Valid Manufacturing License (MD9/MD5 as applicable)
Free Sale Certificate from the country of origin
ISO 13485:2016 certificate
CE Certificate (if applicable)
Device Master File and Plant Master File
Wholesale Drug License
Company Constitution Documents

Timeline and Processing Duration

Process Step	Timeframe
Test License (MD13)	1.5 to 2 months
Product Testing	1 to 1.5 months
MD9 License Application	1 to 1.5 months
Audit and Query Handling	1 to 1.5 months
Total Manufacturing Process	4 to 5 months
MD15 Import License	5 to 6 months

Government Fees and Costs

MD9 Manufacturing License Fees

Application Fee: Rs 50,000 per application
Product Fee: Rs 1,000 per product

MD15 Import License Fees (Class C)

Site Fee: USD 3,000 per site
Product Fee: USD 1,500 per product

Note: Fees are subject to change; it is advisable to verify current fee structures on the CDSCO MD Online Portal.

Common Challenges and Solutions

Challenge: Delays in Product Testing

Solution: Engage early with CDSCO-approved labs and schedule testing well in advance to avoid bottlenecks.

Challenge: Incomplete Documentation Leading to Queries

Solution: Utilize expert consultants to prepare comprehensive Device Master Files, Risk Management Files, and PMFs to ensure thorough compliance.

Challenge: Audit Non-Compliance

Solution: Conduct mock audits and internal quality checks before the official CDSCO audit. Employ experienced notified bodies to guide you through the process.

Expert Consultation and Support

Navigating the CDSCO regulatory environment for Class C devices requires meticulous planning and execution. Our team, with over two decades of experience, offers end-to-end support:

Preparing and reviewing MD9 and MD15 license applications
Conducting internal audits and gap analysis
Facilitating product testing with government-approved labs
Assisting in documentation including Device Master Files and Risk Management

Our proven track record with over 500 successful client approvals makes us your trusted partner.

Getting Started with Your CDSCO License Application

Assess Your Device Classification: Confirm your device’s Class C status using reliable resources such as the Medical Device Classification guide.
Prepare Test License Application (MD13): Submit this first via the CDSCO MD Online Portal.
Engage Accredited Testing Labs: Schedule your product testing early.
Compile Comprehensive Documentation: Leverage our guides on Device and Plant Master Files.
Submit MD9 Manufacturing License Application: Use Form MD7 on the CDSCO portal.
Prepare for Audit: Arrange pre-audit assessments.
For Importers: After manufacturing license approval, proceed to apply for MD15 import license.

By following these steps and partnering with experienced consultants, you can minimize delays and ensure a smooth path to regulatory approval for your analgesic spinal cord electrical stimulation system in India.