CDSCO License for Breast implant
Medical Device Information
Intended Use
Breast implant is used to increase the breast size.
Comprehensive Guide to CDSCO Licensing for Breast Implants (Class C Medical Device)
Breast implants, classified under Class C medical devices, are internal prosthetic replacements designed to augment breast size for cosmetic or reconstructive purposes. Given their critical role in patient safety and long-term health outcomes, regulatory oversight by the Central Drugs Standard Control Organization (CDSCO) is rigorous. With over 25 years of experience assisting 500+ companies in navigating CDSCO licensing, we provide a detailed, step-by-step guide to help manufacturers and importers successfully secure required approvals for breast implants in India.
CDSCO Regulatory Framework for Breast Implants (Class C Devices)
Breast implants fall under the category of internal prosthetic replacements and are notified under CDSCO notification 29/Misc/3/2017-DC dated 06.06.2018. As Class C devices, they require central licensing authority approval for both manufacturing and import activities due to their moderate to high risk profile. This means manufacturers must apply for the MD9 license, while importers must obtain an MD15 import license.
The regulatory framework mandates compliance with the Medical Device Rules 2017, adherence to ISO 13485:2016 quality management systems, and conformity with essential principles including biocompatibility, safety, and performance.
Risk Classification and License Requirements for Breast Implants
Class C devices represent moderate to high risk medical devices that are invasive and intended for long-term use inside the body. Breast implants, by virtue of their internal prosthetic nature, meet this category.
- Manufacturing License: Requires an MD9 license granted by the Central Licensing Authority.
- Import License: Requires an MD15 license issued by the CDSCO Central Authority.
For more detailed classification information, refer to our Medical Device Classification guide.
Manufacturing License Process for Breast Implants (MD9 License)
The MD9 license process is comprehensive, ensuring that manufacturers meet stringent requirements:
- Test License (Form MD13): Initially, obtain a test license allowing product testing in government-approved labs. This takes approximately 1.5 to 2 months.
- Product Testing: Submit breast implant samples to CDSCO-approved testing laboratories. Visit the official Testing Laboratories list for options.
- Document Preparation: Compile technical documentation including Device Master File, Plant Master File, Risk Management File, Essential Principles Checklist, and QMS documentation.
- License Application (Form MD7): Submit the MD9 manufacturing license application via the CDSCO MD Online Portal.
- Audit by CDSCO Inspectors: Undergo an on-site audit covering manufacturing premises, quality systems, and documentation.
- Query Resolution: Respond to any queries raised during the audit or application review promptly.
- License Grant (Form MD9): Upon successful verification, the MD9 license is granted.
The entire process typically spans 4 to 5 months.
Manufacturing License Documents Required for Breast Implants
To ensure a smooth approval process, manufacturers should prepare the following documentation:
- Company Constitution and Registration Proof
- Proof of Premises Ownership or Lease Agreement
- Details and Qualifications of Technical Staff
- Fire Safety and Pollution NOCs
- Device Master File (DMF) outlining design, materials, and manufacturing process (see our detailed Device Master File guide)
- Plant Master File (PMF) describing manufacturing facility and equipment (Plant Master File guide)
- Essential Principles Checklist affirming compliance with regulatory standards
- Risk Management File documenting hazard analysis and mitigation strategies (Risk Management guide)
- Test Reports from approved laboratories
- Product Labels and Instructions for Use (IFU)
- Quality Management System (QMS) documentation, preferably ISO 13485:2016 certified
Import License Process for Breast Implants (MD15 License)
Importers seeking to bring breast implants into India must apply for the MD15 license:
- Document Preparation: Compile necessary licenses and certificates such as manufacturing license, Free Sale Certificate, ISO 13485:2016, CE certificate, DMF, PMF, and wholesale license.
- License Application (Form MD14): Submit the import license application online through the CDSCO MD Online Portal.
- Query Resolution: Address any departmental queries promptly.
- License Grant (Form MD15): Upon successful review, the import license is issued.
The MD15 process generally takes around 5 to 6 months.
Import License Documents Required for Breast Implants
Key documents importers must prepare include:
- Valid Manufacturing License (MD9) from the country of origin
- Free Sale Certificate indicating lawful marketing in the country of origin
- ISO 13485:2016 Quality Management System Certificate
- CE Certificate or equivalent conformity assessment
- Device Master File and Plant Master File
- Wholesale License for distribution in India
- Company Constitution and registration proofs
Timeline and Processing Duration
| License Type | Typical Duration |
|---|---|
| Test License (MD13) | 1.5 – 2 months |
| MD9 Manufacturing License | 4 – 5 months (including test license and audit) |
| MD15 Import License | 5 – 6 months |
Proactive document preparation and prompt response to queries can significantly reduce these timelines.
Government Fees and Costs
| License Type | Government Fees |
|---|---|
| MD9 Manufacturing License | ₹50,000 per application + ₹1,000 per product |
| MD15 Import License | ₹3,000 per site + ₹1,500 per product (Class C devices) |
Additional costs to consider include product testing fees at government-approved labs and audit fees.
Common Challenges and Solutions
Challenge: Delays due to incomplete documentation or non-compliance with essential principles.
- Solution: Utilize detailed checklists and expert reviews before submission.
Challenge: Difficulty in scheduling audits or responding to CDSCO queries.
- Solution: Engage experienced regulatory consultants who can liaise directly with CDSCO and notified bodies.
Challenge: Obtaining accurate and comprehensive test reports.
- Solution: Use CDSCO-approved testing laboratories and plan testing timelines early.
Expert Consultation and Support
Navigating CDSCO licensing for Class C devices like breast implants demands technical expertise and regulatory insight. Our consultancy has successfully guided over 500 companies through this process, ensuring compliance and timely approvals. We offer:
- Comprehensive dossier preparation
- Coordination with notified bodies and CDSCO inspectors
- Strategic planning to minimize processing times
- Post-approval compliance support
Getting Started with Your CDSCO License Application for Breast Implants
- Assess Device Classification: Confirm that your breast implant falls under Class C per CDSCO notifications.
- Prepare Technical Documentation: Begin compiling your Device Master File, Plant Master File, and Risk Management File.
- Apply for Test License (MD13): Initiate the testing phase by submitting Form MD13 via the CDSCO MD Online Portal.
- Select Approved Testing Laboratory: Plan product sampling and testing with a CDSCO-accredited lab.
- Consult Experienced Regulatory Experts: Engage with consultants to review your dossier and guide you through audit preparation.
- Submit MD9 License Application: Once testing is complete and documents are ready, apply for the manufacturing license.
- Plan for Import License: If importing, start compiling import-specific documents early to synchronize with manufacturing approval.
Our team is ready to support your journey into the Indian medical device market with expert advice and hands-on assistance. Reach out today to ensure your breast implant meets all CDSCO regulatory requirements smoothly and efficiently.
