CDSCO License for Diagnostic somatosensory tactile stimulation system

Comprehensive Guide to CDSCO Licensing for Diagnostic Somatosensory Tactile Stimulation System

Navigating the regulatory landscape for medical devices in India can be challenging without expert guidance. With over 25 years of experience and having supported more than 500 companies, we understand the nuances of obtaining the necessary approvals for devices like the Diagnostic Somatosensory Tactile Stimulation System. This neurological device, classified as Risk Class B, plays a vital role in evoked response procedures by applying pneumatic tactile stimuli to the body, particularly to fingers and lips, to assess brain function and detect neurological disorders.

CDSCO Regulatory Framework for Diagnostic Somatosensory Tactile Stimulation Systems

The Central Drugs Standard Control Organization (CDSCO) governs the import and manufacture of medical devices in India, ensuring safety and efficacy. For your Class B device, the licensing authority is the State Licensing Authority, and the applicable manufacturing license is the MD5 license. This framework ensures that all medical devices meet stringent quality and safety standards before they reach the Indian market.

Risk Classification and License Requirements

Your device falls under Class B (Low Moderate Risk) as per CDSCO’s Medical Device Rules, notified under 29/Misc/03/2020-DC (201) dated 27.09.2021. Class B devices require an MD5 license for manufacturing and MD15 license for import, with the manufacturing license granted by the State Licensing Authority.

Manufacturing License Process (MD5) for Class B Devices

The manufacturing license process for Class B devices involves several key steps:

1. Test License Application (Form MD13): Obtain a test license valid for 6 months to manufacture and test samples.
2. Product Testing: Conduct mandatory product testing at CDSCO-approved laboratories to generate test reports.
3. Document Preparation: Compile comprehensive technical documentation including Device Master File and Plant Master File.
4. License Application (Form MD3): Submit the manufacturing license application via the CDSCO MD Online Portal.
5. Audit by Notified Body: Undergo an audit by a notified body from the Notified Bodies List to verify compliance.
6. Query Resolution: Address any queries raised by the department or notified body promptly.
7. License Grant (Form MD5): Receive the manufacturing license upon satisfactory completion of all steps.

Manufacturing License Documents Required

For your Diagnostic Somatosensory Tactile Stimulation System, the following documents are essential:

• Company Constitution (e.g., Memorandum and Articles of Association)
• Proof of ownership or lease of manufacturing premises
• Technical staff qualification and experience details
• Fire No Objection Certificate (NOC)
• Pollution Control Board NOC
• Device Master File (DMF): Detailed device specifications, design, and risk management (Device Master File Guide)
• Plant Master File (PMF): Manufacturing process, quality control, and infrastructure details (Plant Master File Guide)
• Essential Principles Checklist ensuring compliance with Indian regulatory requirements
• Risk Management File documenting hazard analysis and mitigation (Risk Management)
• Test Reports from CDSCO-approved labs (Testing Laboratories)
• Labels and Instructions for Use (IFU)
• Quality Management System (QMS) documents, preferably ISO 13485 certified

Import License Process (MD15) for Class B Devices

If you plan to import the Diagnostic Somatosensory Tactile Stimulation System, an MD15 import license from the Central Licensing Authority is mandatory. The process includes:

1. Document Compilation: Include manufacturing license, Free Sale Certificate, ISO 13485:2016, CE Certificate, DMF, PMF, and Wholesale License.
2. Application Submission: File the application using Form MD14 on the CDSCO MD Online Portal.
3. Departmental Review and Queries: Respond to any clarifications or additional information requests.
4. License Grant: Receive the import license (Form MD15) upon approval.

Import License Documents Required

• Valid Manufacturing License from the country of origin
• Free Sale Certificate from the exporting country
• ISO 13485:2016 Certification
• CE Certificate (if applicable)
• Device Master File
• Plant Master File
• Wholesale Drug License
• Company Constitution and address proof

Timeline and Processing Duration

• MD5 Manufacturing License: Approximately 3 to 4 months including test license issuance (1.5-2 months), testing, audit, and license grant.
• MD15 Import License: Approximately 5 to 6 months from application submission to license issuance.

Government Fees and Costs

• MD5 License: Rs. 5,000 per application plus Rs. 500 per product.
• MD15 Import License: For Class B devices, Rs. 2,000 per site and Rs. 1,000 per product.

Common Challenges and Solutions

• Delayed Testing Reports: Plan testing early with CDSCO-approved labs to avoid bottlenecks.
• Incomplete Documentation: Use our detailed checklists to prepare the DMF, PMF, and Risk Management files accurately.
• Audit Readiness: Engage with notified bodies well before license application to ensure compliance.
• Query Management: Respond promptly and comprehensively to CDSCO queries to avoid unnecessary delays.

Expert Consultation and Support

Our team has helped over 500 medical device manufacturers and importers successfully navigate CDSCO licensing. We provide:

• Tailored gap analysis for your documentation
• End-to-end management of application and audit processes
• Liaison with CDSCO and notified bodies
• Training on regulatory compliance and quality systems

Getting Started with Your CDSCO License Application

1. Evaluate your device’s classification: Confirm Class B status through the Medical Device Classification guide.
2. Register on the CDSCO MD Online Portal: Create your account and familiarize yourself with the submission process.
3. Prepare your test license application (Form MD13): Begin early to avoid delays in product testing.
4. Compile comprehensive documentation: Utilize our Device Master File and Plant Master File guides.
5. Select a notified body for audit: Refer to the Notified Bodies List and schedule your audit.
6. Submit your application: Use the CDSCO MD Online Portal for all filings.

By following these actionable steps and leveraging our expertise, you can streamline your CDSCO licensing journey and bring your Diagnostic Somatosensory Tactile Stimulation System to the Indian market with confidence.