CDSCO License for Suction snakebite kit.
Medical Device Information
Important Notice for Class A Devices
Class A Non-sterile Non Measuring devices are exempt from MD5 and MD15 licenses. Only CDSCO registration is required as per GSR 777(E).
Intended Use
Intended for removing venom from the wound.
Comprehensive Guide to CDSCO Licensing for Suction Snakebite Kit (Class A Medical Device)
As seasoned regulatory consultants with over 25 years of expertise and having assisted 500+ companies in navigating the Indian medical device regulatory landscape, we understand the critical importance of securing timely and compliant CDSCO licenses. The Suction Snakebite Kit, classified as a Class A medical device under the General Hospital or Orthopaedic Instruments category, requires careful adherence to the CDSCO regulatory framework to ensure market entry in India.
Understanding the Suction Snakebite Kit and Its Regulatory Importance
The Suction Snakebite Kit is an essential device designed to remove venom from snakebite wounds, providing critical first aid and potentially saving lives. Given its intended use, the device falls under Class A, denoting low risk. Despite the lower risk classification, CDSCO mandates strict licensing to guarantee safety, efficacy, and quality standards are met. This safeguards patient health and ensures compliance with Indian medical device regulations.
CDSCO Regulatory Framework for Suction Snakebite Kit
The Central Drugs Standard Control Organisation (CDSCO) governs the regulation of medical devices in India. For Class A devices like the Suction Snakebite Kit, the manufacturing license is granted by the State Licensing Authority under the MD5 license scheme, following the Medical Device Rules (MDR) notified under the Drugs and Cosmetics Act.
The device is notified under Notification number 29/Misc./03/2020-DC (193)- Part-3 dated 16.03.2022, confirming its inclusion in the CDSCO regulatory ambit.
Risk Classification and License Requirements
- Risk Class: A (Low risk)
- License Type: Manufacturing License - MD5 (Form MD3 application)
- Licensing Authority: State Licensing Authority
Class A devices undergo a streamlined process compared to higher-risk classes but still require rigorous documentation, testing, and audit.
Manufacturing License Process for Suction Snakebite Kit (MD5 License)
The licensing process includes multiple sequential steps:
Test License (Form MD13): Initially, manufacturers must obtain a test license, valid for 1.5-2 months, allowing production for testing purposes.
Product Testing: Samples are tested at government-approved laboratories to verify compliance with standards. A list of approved testing laboratories is available on the CDSCO portal.
Documentation Preparation: Comprehensive technical documentation, including Device Master File (DMF), Plant Master File (PMF), and Risk Management File, must be prepared meticulously.
Application Submission (Form MD3): Submit the manufacturing license application through the CDSCO MD Online Portal with all supporting documents.
Audit by Notified Body: An audit conducted by a notified body listed on the Notified Bodies List for MD5 Audit is mandatory to assess compliance with Good Manufacturing Practices (GMP).
Resolution of Queries: Address any observations or queries raised by the licensing authority or notified body promptly.
Grant of License (Form MD5): Upon successful completion, the manufacturing license is granted.
Manufacturing License Documents Required for Suction Snakebite Kit
To ensure a smooth application process, prepare the following documents:
- Company Constitution (e.g., MOA, AOA, Partnership Deed)
- Proof of Ownership or Tenancy Agreement of the Manufacturing Premises
- Technical Staff Qualifications and Experience Certificates
- Fire No-Objection Certificate (NOC)
- Pollution Control Board NOC
- Device Master File (DMF): Detailed device specifications, design, manufacturing process (read our Device Master File guide)
- Plant Master File (PMF): Description of manufacturing facilities and quality management systems (Plant Master File guide)
- Essential Principles Checklist demonstrating compliance with Indian Medical Device Rules
- Risk Management File documenting hazard analysis and mitigation (Risk Management reference)
- Test Reports from approved testing laboratories
- Labels, Instructions for Use (IFU), and Packaging Details
- Quality Management System (QMS) documents, usually ISO 13485:2016 certification if available
Import License Process for Suction Snakebite Kit (MD15 License)
Although this guide focuses on manufacturing licenses, importers of the Suction Snakebite Kit must apply for an MD15 import license granted by the Central Licensing Authority.
Key steps include:
- Document preparation including Manufacturing License, Free Sale Certificate, ISO 13485:2016, CE Certificate, DMF, PMF, Wholesale License, and Company Constitution
- Application submission on the CDSCO MD Online Portal
- Resolution of departmental queries
- License grant on Form MD15
The import license process typically takes 5-6 months.
Timeline and Processing Duration
| Stage | Duration |
|---|---|
| Test License (MD13) | 1.5 – 2 months |
| Product Testing | 2 – 3 weeks |
| Document Preparation | 3 – 4 weeks |
| License Application Processing | 2 – 3 months |
| Audit and Query Resolution | 3 – 4 weeks |
| Total Estimated Time | 3 – 4 months |
Government Fees and Costs
- Application Fee: Rs 5,000 per application
- Additional Rs 500 per product
- Audit fees payable to notified bodies may vary but typically range from Rs 50,000 to Rs 1,00,000
Budgeting for these fees upfront can prevent delays.
Common Challenges and Practical Solutions
Incomplete Documentation: Many applicants face delays due to missing or poorly prepared documents. We recommend using checklists and professional document templates.
Testing Delays: Scheduling tests at government-approved labs can be time-consuming. Early booking and parallel preparation of documents can save valuable time.
Audit Non-Compliance: Non-conformities during notified body audits cause repeated visits. Pre-audit internal mock assessments help mitigate this risk.
Query Management: Delayed responses to CDSCO queries prolong license issuance. Assign a dedicated compliance officer for timely communication.
Expert Consultation and Support
Leveraging our 25+ years of experience, we provide end-to-end support—from initial gap assessment and document preparation to audit assistance and query resolution. Our clients benefit from:
- Tailored regulatory strategies for Class A devices like the Suction Snakebite Kit
- Access to a network of notified bodies and testing laboratories
- Up-to-date guidance on CDSCO amendments and notifications
Getting Started with Your CDSCO License Application for Suction Snakebite Kit
- Assess Your Manufacturing Setup: Verify if your premises and personnel meet CDSCO requirements.
- Initiate Test License Application (MD13): Begin by applying for the test license via the CDSCO MD Online Portal.
- Engage with Testing Labs: Coordinate product sample testing early to avoid bottlenecks.
- Prepare Comprehensive Documentation: Utilize expert guides on Device Master Files and Plant Master Files to assemble your technical dossier.
- Schedule Notified Body Audit: Select from the list of notified bodies and prepare for the on-site audit.
- Submit Application and Track Progress: Upload all documents and application forms on the CDSCO portal and monitor status regularly.
By following this structured approach and leveraging expert support, manufacturers can achieve smooth and timely approval of the MD5 manufacturing license for the Suction Snakebite Kit, enabling you to serve the Indian healthcare market effectively and compliantly.
