CDSCO License for Hemostatic knife

Comprehensive Guide to CDSCO Licensing for Hemostatic Knife (Class B Medical Device)

Hemostatic knives play a crucial role in operation theatres by transmitting heat directly to body tissues to achieve hemostasis during surgical procedures. Given the critical nature of this device in patient care, regulatory compliance with the Central Drugs Standard Control Organisation (CDSCO) is mandatory for manufacturers and importers wishing to market this device in India.

With over 25 years of experience assisting more than 500 companies in navigating the CDSCO regulatory landscape, we provide you with a detailed, practical roadmap to secure your medical device license efficiently and compliantly.

CDSCO Regulatory Framework for Hemostatic Knife

The Hemostatic knife is classified under operation theatre medical devices and notified by CDSCO under File No. 29/Misc/03/2020-DC (199) dated 13.9.2021. This classification places it in Risk Class B, which denotes a low to moderate risk device.

Manufacturers and importers must obtain the appropriate license before placing the product in the Indian market. For Class B devices, this involves securing an MD5 manufacturing license if producing domestically or an MD15 import license if importing.

You can initiate or track your application through the CDSCO MD Online Portal.

Risk Classification and License Requirements for Hemostatic Knife

• Risk Class: B (Low to Moderate Risk)
• License Type for Manufacture: MD5 (Form MD3)
• Licensing Authority: State Licensing Authority
• License Type for Import: MD15 (Form MD14)
• Licensing Authority: Central Licensing Authority

Class B devices require a thorough yet streamlined compliance process, including product testing, documentation, and audits.

Manufacturing License Process (MD5) for Hemostatic Knife

The MD5 license process is designed to ensure that manufacturing facilities meet quality standards and that the device complies with essential safety and performance criteria.

Step-by-step Process:

1. Test License (MD13): Before applying for MD5, manufacturers must obtain a Test License on Form MD13, valid for 12 months. Expect 1.5 to 2 months for approval.
2. Product Testing: Conduct testing of the Hemostatic knife at government-approved laboratories listed on the CDSCO Testing Laboratories page. Testing ensures compliance with Indian standards.
3. Documentation Preparation: Prepare key documents including Device Master File, Plant Master File, Essential Principles Checklist, and Risk Management File.
4. Application Submission: File the MD5 license application using Form MD3 on the CDSCO MD Online Portal.
5. Audit by Notified Body: Undergo an on-site audit by a notified body. Refer to the official list of notified bodies to select an authorized auditor.
6. Query Resolution: Address any queries raised by the department or the notified body promptly.
7. License Grant: Upon satisfactory review and audit, the State Licensing Authority issues the MD5 license.

Total Processing Time: Approximately 3 to 4 months (including test license issuance, testing, audit, and approvals).

Manufacturing License Documents Required for Hemostatic Knife

Your application should be supported by comprehensive documentation to avoid delays:

• Company Constitution (Incorporation Certificate, MOA/AOA)
• Proof of Ownership or Lease of Manufacturing Premises
• Details and qualifications of Technical Staff
• Fire NOC and Pollution Control Board NOC
• Device Master File (DMF) detailing design, manufacture, and performance
• Plant Master File (PMF) describing manufacturing facility and process
• Essential Principles Checklist as per CDSCO guidelines
• Risk Management File, including hazard analysis and mitigation strategies
• Test Reports from government-approved labs
• Product Labels and Instructions for Use (IFU)
• Quality Management System (QMS) documents, typically ISO 13485:2016 certified

For expert guidance on compiling a Device Master File or Plant Master File, refer to our detailed Device Master File guide and Plant Master File guide.

Import License Process (MD15) for Hemostatic Knife

If you are an importer of Hemostatic knives, an MD15 license from the Central Licensing Authority is mandatory.

Key Steps Include:

1. Documentation Preparation: Assemble required documents such as manufacturing license of the original manufacturer, Free Sale Certificate, ISO 13485:2016 certification, CE Certificate if applicable, DMF, PMF, wholesale license, and company constitution.
2. Application Submission: File the application on Form MD14 via the CDSCO MD Online Portal.
3. Query Resolution: Respond promptly to any departmental queries.
4. License Issuance: After review, the MD15 import license is granted.

Processing Duration: Typically 5 to 6 months.

Import License Documents Required

• Manufacturing License of the foreign manufacturer
• Free Sale Certificate from the country of origin
• ISO 13485:2016 Certificate
• CE Certificate (if applicable)
• Device Master File
• Plant Master File
• Wholesale License for importers
• Company Constitution documents

Timeline and Processing Duration

Planning your submission with these timelines in mind helps avoid costly delays.

Government Fees and Costs for Hemostatic Knife Licensing

• MD5 Manufacturing License:
  • Application Fee: Rs. 5,000
  • Per Product Fee: Rs. 500
• MD15 Import License:
  • Site Fee (Class B): $2,000 (~Rs. 1.6 Lakh)
  • Per Product Fee (Class B): $1,000 (~Rs. 80,000)

Note: Exact fees may vary with exchange rates and updated regulatory provisions.

Common Challenges and Solutions

Challenge 1: Delays in Test License approval

• Solution: Submit complete documentation upfront and monitor application status regularly on the CDSCO portal.

Challenge 2: Audit non-compliance

• Solution: Conduct pre-audit internal assessments using notified body checklists; train staff thoroughly.

Challenge 3: Incomplete Device Master File

• Solution: Use comprehensive templates and consult experts to ensure all design and manufacturing aspects are covered.

Challenge 4: Responding to regulatory queries

• Solution: Prepare detailed, factual responses with supporting evidence; maintain open communication with CDSCO officials.

Expert Consultation and Support

Navigating CDSCO licensing for specialized devices such as Hemostatic knives demands precision and expertise. Our seasoned regulatory consultants provide:

• End-to-end application preparation and submission
• Pre-audit and gap analysis
• Document drafting and review
• Liaison with CDSCO and notified bodies
• Post-approval compliance support

Our proven track record with over 500 successful licenses underscores our commitment to your market entry success.

Getting Started with Your CDSCO License Application for Hemostatic Knife

1. Determine your license type: Manufacturing (MD5) or Import (MD15).
2. Gather essential documents: Refer to the detailed checklist above.
3. Obtain Test License (for manufacturing): Apply on the CDSCO MD Online Portal.
4. Coordinate product testing: Utilize CDSCO-approved testing labs for compliance verification.
5. Engage a notified body: Schedule audits early by selecting from the list of notified bodies.
6. Submit your application: Complete and accurate submission reduces processing time.
7. Prepare for audits and queries: Implement robust quality systems and maintain clear documentation.

For detailed procedural assistance, consider leveraging expert consultancy services specializing in CDSCO medical device licensing. This strategic partnership can significantly accelerate your Hemostatic knife’s market approval and compliance assurance.

Embarking on your CDSCO licensing journey with thorough preparation and expert guidance ensures that your Hemostatic knife reaches patients safely and compliantly. Contact us today to learn how our 25+ years of regulatory expertise can streamline your approval process.