CDSCO License for Sterile Hemostatic clip applier

Introduction to Sterile Hemostatic Clip Applier and Regulatory Importance

The Sterile Hemostatic Clip Applier is a critical surgical device used in operation theatres to apply hemostatic clips for the ligation of blood vessels, ensuring effective bleeding control during surgeries. As a Class B medical device under the Indian regulatory framework, it requires adherence to stringent guidelines by the Central Drugs Standard Control Organization (CDSCO) to ensure patient safety and product efficacy. Navigating the CDSCO licensing process can be challenging, but with over 25 years of experience and having supported 500+ companies, we provide comprehensive insights to streamline your compliance journey.

CDSCO Regulatory Framework for Sterile Hemostatic Clip Applier

This device falls under the category of operation theatre devices and is notified under File No. 29/Misc/03/2020-DC (199), dated 13.9.2021. According to the Medical Device Rules (MDR) 2017, it is classified as a Class B device, which means it poses a low to moderate risk to patients and users. The regulatory oversight for Class B devices is managed by the State Licensing Authority, and the primary manufacturing license applicable is the MD5 license.

Risk Classification and License Requirements for Class B Devices

Class B devices like the Sterile Hemostatic Clip Applier require an MD5 manufacturing license, issued by the State Licensing Authority. This license ensures that the manufacturing facility complies with Good Manufacturing Practices (GMP) and that the device meets all safety and performance standards established by CDSCO.

Key points about Class B device licensing:

• License Type: MD5 (Manufacturing License)
• Licensing Authority: State Licensing Authority
• Application Form: MD3
• Total Processing Time: Approximately 3-4 months

For comprehensive details on medical device classification, manufacturers can refer to our Medical Device Classification guide.

Manufacturing License Process for Sterile Hemostatic Clip Applier (MD5)

The MD5 license process for Class B devices involves several critical steps:

1. Test License (Form MD13): Before applying for the MD5 license, you must obtain a test license to manufacture the device for testing purposes. This step takes approximately 1.5 to 2 months.

2. Product Testing: The device must be tested in CDSCO-approved laboratories to verify compliance with essential standards. You can find the list of authorized testing labs on the CDSCO Testing Laboratories page.

3. Document Preparation: Compile all required documents, including Device Master File, Plant Master File, Risk Management File, Essential Principles Checklist, and Quality Management System documentation.

4. Application Submission: Apply for the MD5 license on the CDSCO MD Online Portal using Form MD3.

5. Audit by Notified Body: A mandatory audit is conducted by a notified body to assess compliance. Refer to the list of notified bodies for audit agencies.

6. Resolution of Queries: Address any queries or clarifications raised by the licensing authority or notified body.

7. Grant of License: Upon successful review, the MD5 license is granted on Form MD5.

Manufacturing License Documents Required for Sterile Hemostatic Clip Applier

To ensure a smooth application process, gather the following mandatory documents:

• Company Constitution (Incorporation Certificate, Memorandum & Articles of Association)
• Proof of Ownership or Lease of Manufacturing Premises
• Qualification and Experience Certificates of Technical Staff
• Fire NOC and Pollution Control Board NOC
• Device Master File detailing device specifications and design (Device Master File Guide)
• Plant Master File describing manufacturing infrastructure (Plant Master File Guide)
• Essential Principles Checklist confirming compliance with safety standards
• Risk Management File aligned with ISO 14971 principles (Risk Management)
• Test Reports from CDSCO-approved laboratories
• Product Labeling and Instructions for Use (IFU)
• Quality Management System (QMS) documents, preferably ISO 13485:2016 certification

Import License Process for Sterile Hemostatic Clip Applier (MD15)

For importers seeking to bring the Sterile Hemostatic Clip Applier into India, the MD15 import license is mandatory. This license is issued by the Central Licensing Authority and involves:

• Preparation of required documentation including manufacturing and quality certifications
• Application submission via Form MD14 on the CDSCO MD Online Portal
• Resolution of queries raised by CDSCO
• Final license grant on Form MD15

Note that unlike manufacturing licenses, a test license is not required for imports.

Import License Documents Required

Importers must submit:

• Valid Manufacturing License from the country of origin
• Free Sale Certificate
• ISO 13485:2016 Certification
• CE Certificate or equivalent international certification
• Device Master File and Plant Master File
• Wholesale License in India
• Company Constitution documents

For detailed guidance, consult our Import License Guide.

Timeline and Processing Duration

Import license processing typically takes 5 to 6 months due to central authority review.

Government Fees and Costs

For Class B devices, the fee structure for manufacturing license (MD5) is as follows:

• Application Fee: Rs. 5,000 per application
• Product Fee: Rs. 500 per product

Additional costs to consider:

• Testing charges at government-approved labs
• Notified body audit fees
• Consultancy and documentation preparation fees (if outsourced)

Budgeting for these expenses upfront can prevent delays.

Common Challenges and Solutions

1. Delayed Test Reports: Testing lab backlogs can stall your timeline. Solution: Book slots early and consider multiple CDSCO-approved labs.

2. Incomplete Documentation: Missing or inadequate Device Master File or Risk Management documentation leads to rejections. Solution: Utilize expert consultants to prepare comprehensive files.

3. Audit Non-compliance: Facilities often fail notified body audits due to QMS or infrastructure gaps. Solution: Conduct internal audits and pre-assessment before notified body visit.

4. Query Resolution Delays: Slow response to CDSCO queries prolongs approval. Solution: Assign dedicated personnel to address queries promptly.

Expert Consultation and Support

With our extensive experience in navigating CDSCO processes for over 500 clients, we offer tailored support including:

• Preparation of Device and Plant Master Files
• Risk Management implementation
• Test license acquisition and coordination with testing labs
• Audit readiness and follow-up
• Application submission and query management

Our expert team ensures your sterile hemostatic clip applier meets all regulatory standards efficiently.

Getting Started with Your CDSCO License Application

1. Assess Your Device Classification: Confirm your device is Class B via regulatory guidance.

2. Prepare Documentation: Start gathering your Device Master File, Plant Master File, and Quality Management System documents.

3. Apply for Test License: Submit Form MD13 on the CDSCO MD Online Portal to begin manufacturing for testing.

4. Schedule Product Testing: Coordinate with CDSCO-approved testing laboratories early.

5. Engage a Notified Body: Select and schedule your audit with a notified body from the official Notified Bodies list.

6. Submit MD5 License Application: After successful testing and audit, apply using Form MD3.

7. Respond Promptly to Queries: Maintain open communication with CDSCO and promptly resolve any issues.

Starting early and following a structured approach can significantly reduce licensing timelines and hurdles. Reach out to experienced regulatory consultants who can guide you step-by-step to market your sterile hemostatic clip applier in India with full compliance and confidence.