CDSCO License for Internal tissue marker.

Introduction to Internal Tissue Marker and CDSCO Licensing

Internal tissue markers are specialized medical devices designed for prescription use in demarcating selected sites on internal tissues during or prior to surgical procedures. Classified under the dermatological and plastic surgery category, these devices play a critical role in improving surgical outcomes by providing precise localization. Given their medical significance, regulatory compliance with the Central Drugs Standard Control Organization (CDSCO) is mandatory for manufacturers and importers aiming to market this device in India.

With over 25 years of experience and having supported 500+ companies in securing CDSCO licenses, we understand the nuances involved in navigating the regulatory landscape for Class A devices like internal tissue markers. This comprehensive guide covers the entire process from classification, documentation, timelines, costs, and practical tips to secure your manufacturing or import license efficiently.

CDSCO Regulatory Framework for Internal Tissue Marker

The CDSCO regulates medical devices under the Medical Device Rules (MDR), 2017, amended periodically. Internal tissue markers fall under Class A devices—considered low risk—subject to licensing and quality control but with streamlined requirements compared to higher risk classes.

The regulatory framework mandates:

• Obtaining a manufacturing license (MD5) or import license (MD15) before marketing
• Compliance with Essential Principles of Safety and Performance
• Implementation of a robust Quality Management System (QMS) aligned with ISO 13485:2016

The notification governing internal tissue markers is 29/Misc./03/2020-DC (147) dated 26.7.2021, confirming their classification and regulatory pathway.

Risk Classification and License Requirements for Class A Devices

According to the CDSCO classification:

• Class A devices are low risk and require a manufacturing license MD5 issued by the state licensing authority.
• For internal tissue markers (Class A), manufacturers must first obtain a test license (MD13), conduct product testing through government-approved laboratories, and undergo a notified body audit.

This process ensures that the device meets safety and performance standards before commercial distribution.

For detailed classification guidance, refer to our Medical Device Classification resource.

Manufacturing License Process for Internal Tissue Marker (MD5 License)

The MD5 license process is comprehensive yet tailored for Class A devices and involves the following key steps:

1. Test License (Form MD13): Apply to the state licensing authority to obtain a test license, valid for 6 months, allowing you to manufacture limited quantities for testing purposes.

2. Product Testing: Submit your internal tissue marker samples to CDSCO-approved testing laboratories. Testing typically takes 4–6 weeks. Refer to the official Testing Laboratories list for selection.

3. Document Preparation: Compile all required documents, including Device Master File (DMF), Plant Master File (PMF), Risk Management File, and QMS documentation.

4. Application Submission: File your manufacturing license application on Form MD3 through the CDSCO MD Online Portal.

5. Audit by Notified Body: A notified body conducts a factory audit to verify compliance. Check the list of notified bodies for authorized auditors.

6. Query Resolution: Address any queries raised during the audit or by the licensing authority promptly.

7. License Grant: Upon successful evaluation, you receive the MD5 license (Form MD5), authorizing manufacturing.

For an in-depth walkthrough, consult our MD5 License Guide.

Manufacturing License Documents Required for Internal Tissue Marker

Specific documentation is crucial for a smooth approval process. For the internal tissue marker (Class A), prepare the following:

• Company Constitution: Certificate of incorporation and memorandum of association
• Proof of Premises Ownership: Rent agreement or ownership deed
• Technical Staff Details: Qualification and experience certificates
• No Objection Certificates: Fire safety and pollution control clearances
• Device Master File (DMF): Detailed device description, design, and manufacturing processes (Device Master File Guide)
• Plant Master File (PMF): Facility details, quality control systems (Plant Master File Guide)
• Essential Principles Checklist: Compliance with safety and performance requirements
• Risk Management File: Hazard analysis and mitigation strategies (Risk Management)
• Test Reports: From CDSCO-approved labs
• Labels and Instructions for Use (IFU): Clear, compliant labeling
• Quality Management System (QMS) Documents: ISO 13485 implementation evidence

Preparing these documents meticulously reduces back-and-forth with regulators.

Import License Process for Internal Tissue Marker (MD15 License)

While the focus here is manufacturing, importers of internal tissue markers must obtain an MD15 license from the central licensing authority. The process involves:

• Document preparation including manufacturing license from the country of origin, free sale certificate, ISO 13485:2016 certification, CE mark if applicable, Device Master File, and Plant Master File
• Application submission on Form MD14 via the CDSCO MD Online Portal
• Queries resolution
• Grant of MD15 license

Note: Unlike manufacturing, import licensing does not require a test license, but the overall timeline extends to 5-6 months.

For detailed import procedures, review our Import License Guide.

Import License Documents Required

Key documents include:

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

Timeline and Processing Duration

Total time for MD5 license: Approximately 3 to 4 months from start to finish.

Manufacturers should plan accordingly to accommodate this timeline, especially when launching new products.

Government Fees and Costs

For the Internal Tissue Marker (Class A):

• Test License (MD13): Usually minimal fees charged by the state authority
• MD5 License Application: Rs 5,000 per application
• Product-wise Fees: Rs 500 per product

Additional costs include testing laboratory fees (variable, typically Rs 50,000–1,00,000 per test depending on complexity) and notified body audit charges.

Budgeting for these costs upfront helps avoid surprises.

Common Challenges and Practical Solutions

Challenge 1: Delays in Test License Approval

Solution: Submit a complete application with all supporting documents upfront. Stay in regular contact with the state licensing authority.

Challenge 2: Product Testing Failures

Solution: Conduct internal pre-testing to identify potential shortcomings before sending samples to government-approved labs.

Challenge 3: Audit Non-conformities

Solution: Engage with experienced notified bodies early; conduct internal audits and gap assessments prior to formal audits.

Challenge 4: Documentation Gaps

Solution: Use standardized templates for DMF and PMF. Our detailed guides on Device Master Files and Plant Master Files provide actionable frameworks.

Expert Consultation and Support

Navigating CDSCO regulations can be complex, especially for first-time applicants. Our consultancy services, backed by over 25 years of domain expertise, have streamlined licensing for 500+ companies across India.

We assist with:

• Gap analysis and readiness assessments
• Documentation drafting and review
• Liaison with CDSCO and notified bodies
• Training your technical and regulatory teams

Our hands-on approach ensures timely approvals and compliance sustainability.

Getting Started with Your CDSCO License Application

1. Assess Device Classification: Confirm your internal tissue marker as Class A per CDSCO guidelines.

2. Prepare Documentation: Begin compiling your Device Master File, Plant Master File, Risk Management File, and QMS documents.

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

4. Schedule Product Testing: Identify and engage with approved testing labs from the official list.

5. Plan Audit Timing: Coordinate with a notified body early to secure audit dates.

6. Submit MD5 Application: Once testing and documentation are complete, apply for your manufacturing license on Form MD3.

7. Engage Experts: Consider partnering with regulatory consultants to expedite the process and ensure compliance.

Taking these practical steps will position your company for a successful launch of internal tissue markers in the Indian market, minimizing regulatory hurdles and expediting time-to-market.

For personalized assistance, feel free to contact our expert team to kickstart your CDSCO licensing journey.