CDSCO License for Saddle block anaesthesia kit
Medical Device Information
Intended Use
A collection of devices designed to deliver an analgesic or anaesthetic agent to the lower dural sac in the region corresponding to the buttocks, in the perineum, or to the inner aspects of the thighs.

Comprehensive Guide to CDSCO Licensing for Saddle Block Anaesthesia Kits (Class B Medical Device)
As seasoned regulatory consultants with over 25 years of experience and having successfully guided 500+ companies through the complexities of CDSCO licensing, we understand the critical importance of a seamless approval process for medical devices like the Saddle Block Anaesthesia Kit. This specialized anesthesiology device is designed to deliver analgesic or anesthetic agents to precise anatomical regions including the lower dural sac, buttocks, perineum, and inner thighs. Navigating India’s regulatory landscape, particularly for Class B devices, requires a strategic approach backed by detailed knowledge of CDSCO procedures, documentation, timelines, and fees.
CDSCO Regulatory Framework for Saddle Block Anaesthesia Kit
The Central Drugs Standard Control Organization (CDSCO) regulates medical devices under the Medical Device Rules, 2017. The Saddle Block Anaesthesia Kit is classified as a Class B device, reflecting a moderate risk level that demands compliance with statutory manufacturing and import licensing requirements. Adherence to these regulations ensures patient safety and market access within India.
Risk Classification and License Requirements for Class B Devices
Per the CDSCO classification system, Class B devices pose moderate risk and therefore require a manufacturing license under the MD5 category, issued by the State Licensing Authority. For importers, an MD15 license issued by the Central Licensing Authority is mandatory.
You can verify device classification and applicable rules on our detailed Medical Device Classification resource.
Manufacturing License Process (MD5) for Saddle Block Anaesthesia Kit
For manufacturers aiming to produce the Saddle Block Anaesthesia Kit in India, the MD5 license process unfolds in several critical stages:
Test License Application (Form MD13): Initiate your journey by applying for a test license, which generally takes 1.5 to 2 months. This license permits prototype testing of your device in government-approved labs.
Product Testing: Submit your device samples to government-designated testing laboratories to obtain requisite test reports. Refer to the Testing Laboratories list for approved facilities.
Document Preparation: Compile comprehensive documentation including Device Master File (DMF), Plant Master File (PMF), Risk Management File, Essential Principles Checklist, Quality Management System (QMS) documents, and others.
License Application Submission (Form MD3): Apply for the MD5 license via the CDSCO MD Online Portal.
Audit by Notified Body: A notified body, from the official Notified Bodies List, will conduct an on-site audit of your manufacturing premises and QMS.
Query Resolution and Grant: Respond promptly to any queries raised by the CDSCO or notified body. Upon satisfactory review, the MD5 license (Form MD5) will be granted.
Manufacturing License Documents Required
To ensure a smooth application process, prepare the following documents meticulously:
- Company Constitution (e.g., Memorandum and Articles of Association)
- Proof of ownership or lease of manufacturing premises
- Details and qualifications of technical staff
- Fire and Pollution NOCs
- Device Master File (technical specifications, design data, manufacturing process details) – our Device Master File guide offers valuable insights
- Plant Master File detailing infrastructure and equipment – see our Plant Master File guide
- Essential Principles Checklist demonstrating compliance to regulatory standards
- Risk Management File highlighting hazard analysis and mitigation strategies
- Test Reports from approved laboratories
- Product Labels and Instructions for Use (IFU)
- Quality Management System documentation (ISO 13485:2016 compliance recommended)
Import License Process (MD15) for Saddle Block Anaesthesia Kit
Importers of Saddle Block Anaesthesia Kits must obtain an MD15 license granted by the Central Licensing Authority. The process involves:
Document Preparation: Assemble your dossier including manufacturing license of the foreign manufacturer, Free Sale Certificate, ISO 13485:2016 certificate, CE certificate (if available), Device Master File, Plant Master File, wholesale license, and company constitution.
License Application Submission (Form MD14): Submit your import license application through the CDSCO MD Online Portal.
Query Resolution: Address any departmental queries promptly.
License Grant: The MD15 license will be granted within approximately 5-6 months.
Import License Documents Required
- Manufacturing License of the foreign manufacturer
- Free Sale Certificate from the country of origin
- ISO 13485:2016 Certification
- CE Certificate (if applicable)
- Device Master File
- Plant Master File
- Wholesale License in India
- Company Constitution documents
Timeline and Processing Duration
License Type | Process Steps | Estimated Duration |
---|---|---|
MD5 Manufacturing | Test license → Product Testing → Application → Audit → License Grant | 3-4 months |
MD15 Import | Document prep → Application → Query resolution → License Grant | 5-6 months |
Planning for contingencies is crucial as delays may occur due to incomplete documentation or audit non-compliance.
Government Fees and Costs
- MD5 Manufacturing License: INR 5,000 per application + INR 500 per product
- MD15 Import License:
- Class B Devices: USD 2,000 per site + USD 1,000 per product
These fees are payable online via the CDSCO portal during application submission.
Common Challenges and Solutions
Challenge: Delays due to incomplete documentation.
Solution: Engage experts to conduct a thorough gap analysis early, ensuring all documents like Device Master File and Risk Management File meet CDSCO standards.
Challenge: Audit non-compliance from notified bodies.
Solution: Pre-audit internal assessments and corrective action plans can mitigate risks. Utilizing the Notified Bodies List helps select experienced auditors.
Challenge: Product testing bottlenecks.
Solution: Prioritize submissions to government-approved testing labs and maintain open communication channels. The Testing Laboratories directory is a useful resource.
Expert Consultation and Support
With over two decades in medical device regulatory affairs, we offer tailored consulting services to simplify your journey. From preparation of Device and Plant Master Files to audit readiness and application submission via the CDSCO MD Online Portal, our team ensures compliance and accelerates approval.
Getting Started with Your CDSCO License Application for Saddle Block Anaesthesia Kit
Assess Your Device Classification: Confirm Class B classification and regulatory requirements.
Prepare Documentation: Begin compiling your Device Master File, Risk Management File, and other mandatory documents.
Apply for Test License (MD13): Initiate product testing early to avoid bottlenecks.
Submit Manufacturing License Application (MD3): Use the CDSCO MD Online Portal for streamlined submission.
Schedule Audit with Notified Body: Select an appropriate notified body from the official list.
Monitor Application Progress: Respond promptly to queries to ensure timely license grant.
For Importers: Prepare your dossier and apply for MD15 license at CDSCO portal.
Ready to navigate the CDSCO licensing pathway for your Saddle Block Anaesthesia Kit? Contact us for a detailed consultation and step-by-step support to secure your license efficiently and compliantly.