CDSCO License for Non-sterile Hemostatic clip  applier

Comprehensive Guide to CDSCO Licensing for Non-sterile Hemostatic Clip Applier (Class A Medical Device)

Navigating the Indian regulatory landscape for medical devices can be challenging, especially for manufacturers and importers aiming to market specialized surgical tools like the Non-sterile Hemostatic Clip Applier. This device, designed for ligation of blood vessels during surgery, falls under Class A risk category as per the CDSCO medical device classification, and requires a carefully managed licensing process. With over 25 years of experience helping 500+ companies secure CDSCO licenses, we provide you with an in-depth, actionable roadmap to obtaining your manufacturing or import license efficiently.

Understanding the CDSCO Regulatory Framework for Non-sterile Hemostatic Clip Applier

The Central Drugs Standard Control Organization (CDSCO) regulates medical devices in India under the Ministry of Health and Family Welfare. Since the Non-sterile Hemostatic Clip Applier is an operation theatre device with low risk (Class A), the licensing authority is the State Licensing Authority (SLA). The relevant license for manufacturing this device is the MD5 license, granted after a systematic process involving testing, documentation, and audit.

Risk Classification and License Requirements

• Device: Non-sterile Hemostatic Clip Applier
• Risk Class: Class A (Low risk)
• Regulatory License: MD5 Manufacturing License (Form MD3 application)
• Authority: State Licensing Authority
• Notification: File No. 29/Misc/03/2020-DC (199), dated 13.9.2021

Class A devices like this require compliance with basic safety and performance standards but have a relatively streamlined approval compared to higher-risk devices.

Manufacturing License Process (MD5) for Class A Devices

The end-to-end process for obtaining the MD5 license for manufacturing a Non-sterile Hemostatic Clip Applier typically takes 3-4 months and involves several distinct steps:

1. Obtain Test License (Form MD13) – Apply for a test license allowing limited manufacturing for testing purposes. This stage takes approximately 1.5 to 2 months.
2. Product Testing – Get the device tested at CDSCO-recognized government-approved laboratories. Refer to the list of testing laboratories for options.
3. Document Preparation – Compile all required documentation including Device Master File (DMF), Plant Master File (PMF), risk management documents, and product labeling.
4. Apply for Manufacturing License (Form MD3) – Submit the application through the CDSCO MD Online Portal, along with fees.
5. Audit by Notified Body – A notified body conducts an on-site audit verifying compliance. Check the list of notified bodies authorized for MD5 audits.
6. Address Queries – Respond promptly to any queries from the department or notified body.
7. License Grant (Form MD5) – Upon satisfactory compliance, the MD5 manufacturing license is granted.

Manufacturing License Documents Required

Successful application hinges on meticulous documentation. Key documents include:

• Company Constitution and Incorporation Proof
• Proof of Ownership or Lease of Manufacturing Premises
• Details and Qualifications of Technical Staff
• Fire No Objection Certificate (Fire NOC)
• Pollution Control Board Clearance (Pollution NOC)
• Device Master File (DMF) – detailed device specifications, design, and manufacturing process (Device Master File Guide)
• Plant Master File (PMF) – manufacturing facility description and quality systems (Plant Master File Guide)
• Essential Principles Checklist confirming compliance with safety standards
• Risk Management File documenting hazard identification and mitigation (Risk Management)
• Test Reports from CDSCO-approved laboratories
• Product Labels and Instructions for Use (IFU)
• Quality Management System (QMS) Documents – typically ISO 13485:2016 certification

Import License Process (MD15)

If you are an importer rather than a manufacturer, the relevant license is the MD15 import license. For Class A devices, the process involves:

• Preparing comprehensive documentation including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016 certification, CE certificates, DMF and PMF, and wholesale license.
• Submitting the application on Form MD14 through the CDSCO MD Online Portal.
• Resolving any queries raised.
• The central licensing authority grants the MD15 license typically within 5-6 months.

Note that import licensing does not require a test license but demands robust evidence of compliance and quality.

Import License Documents Required

• Valid manufacturing license from the country of origin
• Free Sale Certificate
• ISO 13485:2016 Certification
• CE Certificate (if applicable)
• Device Master File and Plant Master File
• Wholesale License
• Company Constitution and Incorporation Proof

Timeline and Processing Duration

For import licenses (MD15), the process is longer, averaging 5-6 months.

Government Fees and Costs

• MD5 Manufacturing License Fees: Rs. 5,000 per application + Rs. 500 per product
• Test License Fees (MD13): Included in overall application
• Product Testing Costs: Variable depending on lab and tests but typically Rs. 50,000–80,000 per product
• Audit Fees: Charged by notified bodies separately, generally Rs. 50,000–100,000

Budgeting realistically for these fees and timelines is crucial for smooth project planning.

Common Challenges and Practical Solutions

• Delays in Testing: Coordinate early with approved labs and book slots in advance to avoid bottlenecks.
• Incomplete Documentation: Use checklists and templates from expert guides like our MD5 License Guide to ensure all files are robust.
• Audit Non-Compliance: Conduct internal mock audits and pre-assessments to prepare your site and team.
• Query Resolution Delays: Assign a dedicated regulatory liaison to respond promptly and comprehensively.

Expert Consultation and Support

Our extensive experience with over 500 successful CDSCO licensing projects means we can help you avoid common pitfalls and accelerate approvals. From tailored document preparation to audit readiness and liaison with CDSCO officials, our end-to-end support is designed to reduce your time-to-market.

Getting Started with Your CDSCO License Application for Non-sterile Hemostatic Clip Applier

1. Assess Your Risk Class – Confirm Class A status using official classification tools.
2. Prepare Your Test License Application – Gather preliminary documents and submit Form MD13 via the CDSCO MD Online Portal.
3. Engage with Approved Testing Labs – Plan product testing early.
4. Compile Complete Documentation – Utilize expert guides for DMF, PMF, and risk management files.
5. Schedule Notified Body Audit – Contact an authorized notified body from the official list.
6. Submit Manufacturing License Application (Form MD3) – After successful testing and audit.
7. Manage Query Responses Promptly – Maintain clear communication channels.

Taking these concrete steps will put you on a clear path to securing your MD5 license, enabling you to manufacture and market your Non-sterile Hemostatic Clip Applier confidently in India. For personalized support and comprehensive regulatory consulting, please reach out to our team.