CDSCO License for Tissue Expanders
Medical Device Information
Intended Use
Intended to be used in breast reconstruction or treatment of soft tissue deformities such as used following mastectomy or for treatment of underdeveloped breasts.
Comprehensive Guide to CDSCO Licensing for Tissue Expanders (Class C Medical Device)
Tissue expanders are critical internal prosthetic replacements used primarily in breast reconstruction and treatment of soft tissue deformities post-mastectomy or for underdeveloped breasts. Due to their invasive nature and patient safety considerations, they are classified as Class C devices under the Indian medical device regulatory framework. Successfully navigating the Central Drugs Standard Control Organization (CDSCO) licensing process is essential for manufacturers and importers aiming to market tissue expanders in India.
With over 25 years of experience and having supported 500+ companies, we provide an authoritative, step-by-step guide on obtaining the mandatory licenses, detailing timelines, costs, required documentation, and practical tips tailored specifically for tissue expanders.
CDSCO Regulatory Framework for Tissue Expanders
Tissue expanders fall under the category of Internal Prosthetic Replacements and are regulated as Class C medical devices as per CDSCO Notification 29/Misc/3/2017-DC (292) dated 06.06.2018. Regulatory oversight for Class C devices is centralized with the CDSCO Central Licensing Authority, which ensures rigorous evaluation given the moderate to high risk associated with these implants.
Manufacturers require an MD9 manufacturing license (Form MD7) issued by the CDSCO Central Office, while importers must obtain an MD15 import license (Form MD14). Both licenses necessitate compliance with the Medical Device Rules 2017 and alignment with essential principles of safety and performance.
For additional context on medical device classification, consult our Medical Device Classification guide.
Risk Classification and License Requirements for Tissue Expanders
| Device | Risk Class | License Type | Licensing Authority | Approximate Timeline | Fees (INR) |
|---|---|---|---|---|---|
| Tissue Expanders | Class C | MD9 | CDSCO Central Authority | 4-5 months | ₹50,000 + ₹1,000/product |
| Tissue Expanders | Class C | MD15 (Import) | CDSCO Central Authority | 5-6 months | ₹2,25,000 + per product fee |
Class C devices like tissue expanders require a comprehensive review involving a test license phase, product testing in CDSCO-approved labs, document audits, and inspections.
Manufacturing License Process for Tissue Expanders (MD9 License)
The MD9 license is mandatory for Indian manufacturers of tissue expanders. The process unfolds as follows:
- Test License Application (Form MD13): Before full manufacturing license application, a test license is required. This allows manufacturing for testing and evaluation.
- Product Testing: Testing must be conducted in government-approved laboratories to verify compliance with applicable standards.
- Documentation Preparation: Compile detailed technical documents, quality management system (QMS) records, Device Master File (DMF), and Plant Master File (PMF).
- License Application (Form MD7): Submit the MD9 license application through the CDSCO MD Online Portal.
- Audit and Inspection: CDSCO officials perform an on-site audit focused on manufacturing processes, QMS, and compliance with essential principles.
- Query Resolution: Address any concerns or queries raised during audit or review.
- Grant of License (Form MD9): Upon successful compliance, CDSCO issues the manufacturing license.
For a stepwise walkthrough, refer to our detailed MD9 License Guide.
Manufacturing License Documents Required for Tissue Expanders
Prepare the following documentation meticulously to ensure a smooth approval:
- Company Constitution Proof: Incorporation certificates, partnership deeds, or LLP agreements.
- Premises Ownership Proof: Sale deeds or lease agreements of manufacturing premises.
- Qualified Technical Staff Details: CVs and qualification certificates of responsible technical personnel.
- Fire and Pollution NOCs: Certificates from local authorities ensuring safety compliance.
- Device Master File (DMF): Detailed design, development, and manufacturing process information. Our Device Master File guide offers comprehensive insights.
- Plant Master File (PMF): Facility layout, equipment lists, and process descriptions. Learn more with our Plant Master File guide.
- Essential Principles Checklist: Document describing compliance with safety and performance principles.
- Risk Management File: Evidence of risk assessment and mitigation strategies. See best practices in our Risk Management guide.
- Test Reports: Product testing certificates from CDSCO-approved testing laboratories. Find recognized labs on the Testing Laboratories list.
- Labels and Instructions for Use (IFU): Finalized product labeling and user manuals.
- Quality Management System (QMS) Documents: ISO 13485:2016 certification and related process documents.
Import License Process for Tissue Expanders (MD15 License)
Importers of tissue expanders must secure an MD15 import license issued by the CDSCO Central Licensing Authority. The procedure is:
- Documentation Preparation: Gather manufacturing license from country of origin, Free Sale Certificate, ISO 13485:2016 certificate, CE certificate (if applicable), DMF, PMF, and wholesale license.
- Application Submission: Apply using Form MD14 on the CDSCO MD Online Portal.
- Evaluation and Queries: CDSCO reviews documents and requests clarifications if needed.
- Grant of License (Form MD15): Upon satisfactory review, import license is granted.
Detailed guidance is available in our Import License Guide.
Import License Documents Required for Tissue Expanders
Key documents to prepare include:
- Valid Manufacturing License from the country of origin.
- Free Sale Certificate verifying marketing approval abroad.
- ISO 13485:2016 Quality Management System certificate.
- CE Certificate or equivalent conformity documentation.
- Device Master File (DMF) and Plant Master File (PMF).
- Wholesale Drug License under the Drugs and Cosmetics Act.
- Company Constitution and relevant incorporation documents.
Timeline and Processing Duration
| Process Step | Duration |
|---|---|
| Test License (MD13) | 1.5 to 2 months |
| Product Testing | 1 to 1.5 months |
| Documentation Preparation | Concurrent with above |
| License Application Review (MD9) | 1 to 1.5 months |
| Audit and Query Resolution | 1 month |
| Total Manufacturing License Time | Approx. 4-5 months |
| Import License Processing (MD15) | Approx. 5-6 months |
Timelines can vary based on document completeness and responsiveness to queries.
Government Fees and Costs
| License Type | Application Fee | Per Product Fee |
|---|---|---|
| MD9 Manufacturing | ₹50,000 | ₹1,000 |
| MD15 Import | ₹2,25,000* | Varies* |
*Import license fees depend on device class and site; for Class C devices, fees typically total around ₹2,25,000 plus product-wise fees.
Additional costs include testing fees charged by approved labs and fees for notified body audits.
Common Challenges and Solutions
- Incomplete Documentation: Many applicants miss critical documents like risk management files or Device Master Files. Solution: Use comprehensive checklists and expert pre-submission reviews.
- Delays in Product Testing: Limited availability of slots at CDSCO-approved labs can cause bottlenecks. Solution: Schedule testing early and consider multiple labs from the Testing Laboratories list.
- Audit Non-Compliance: Non-adherence to QMS or manufacturing practices leads to audit observations. Solution: Conduct internal audits and pre-audit readiness assessments.
- Query Resolution Delays: Slow responses to CDSCO queries extend timelines. Solution: Assign dedicated regulatory personnel to handle communications promptly.
Expert Consultation and Support
Navigating CDSCO licensing for Class C tissue expanders requires expert knowledge of evolving regulations, technical standards, and procedural nuances. We have supported over 500 companies in successfully obtaining MD9 manufacturing and MD15 import licenses, providing end-to-end regulatory strategy, documentation support, and liaison with CDSCO.
Our proven approach includes:
- Customized gap assessments
- Preparation of DMF and PMF aligned with CDSCO expectations
- Coordination with notified bodies and testing labs
- Proactive query management
Contact our regulatory experts to accelerate your tissue expander licensing journey.
Getting Started with Your CDSCO License Application
- Classify Your Device: Confirm tissue expanders as Class C devices according to CDSCO guidelines.
- Register on CDSCO MD Online Portal: Create your account and familiarize yourself with application procedures.
- Initiate Test License Application (MD13): Begin with the test license for manufacturing evaluation.
- Engage a CDSCO-Approved Testing Laboratory: Arrange your product testing early to avoid delays.
- Prepare Complete Documentation: Use our detailed checklists and guides for Device Master Files, Plant Master Files, and risk management.
- Submit MD9 Application: Once test license and testing are complete, apply for the manufacturing license.
- Plan for Audit: Schedule and prepare for CDSCO inspections and notified body audits.
- Respond Promptly to Queries: Ensure fast turnaround to maintain timelines.
For application submission, visit the official CDSCO MD Online Portal.
By following these actionable steps and leveraging expert support, manufacturers and importers can confidently enter the Indian market with compliant, high-quality tissue expanders.
For further expert advice, detailed templates, or personalized consulting services, reach out to our regulatory team experienced in Class C medical device licensing.
