CDSCO License for Antimicrobial postsurgical brassiere
Medical Device Information
Important Notice for Class A Devices
Class A Non-sterile Non Measuring devices are exempt from MD5 and MD15 licenses. Only CDSCO registration is required as per GSR 777(E).
Intended Use
A woman's undergarment which includes antimicrobial properties designed to support and/or contour the breast(s) or hold a dressing in place after surgical intervention (e.g. thoracic surgery, mastectomy, lumpectomy)
Comprehensive Guide to CDSCO Licensing for Antimicrobial Postsurgical Brasieres (Class A Medical Devices)
As a trusted regulatory consultancy with over 25 years of experience and a track record of aiding 500+ companies in successfully obtaining CDSCO licenses, we understand the nuances involved in bringing specialized medical devices like the Antimicrobial Postsurgical Brassiere to the Indian market. This guide offers an expert, step-by-step roadmap tailored specifically for manufacturers of this Class A oncology undergarment designed to support post-surgical care.
Introduction: Understanding the Antimicrobial Postsurgical Brassiere and Regulatory Importance
The Antimicrobial Postsurgical Brassiere is a vital Class A medical device intended for women recovering from surgeries such as mastectomy, lumpectomy, or thoracic interventions. With integrated antimicrobial properties, this specialized undergarment aids in wound protection, dressing retention, and breast contouring, significantly improving post-operative outcomes.
Given its medical purpose and classification, regulatory compliance with India’s Central Drugs Standard Control Organization (CDSCO) is mandatory before manufacturing or marketing within the country. Non-compliance can lead to enforcement actions, delays in market entry, and reputational harm.
CDSCO Regulatory Framework for Antimicrobial Postsurgical Brasieres
India classifies medical devices into four risk classes (A to D) based on potential risk to patients. Your device falls under Class A, the lowest risk category, governed by the State Licensing Authority under the MD5 license framework.
The regulatory pathway involves obtaining a Test License (Form MD13) followed by the Manufacturing License (Form MD3) for MD5. All applications must be filed via the official CDSCO MD Online Portal.
Risk Classification and License Requirements for Your Device
- Device Name: Antimicrobial Postsurgical Brassiere
- Risk Class: A (Low Risk)
- Category: Oncology
- Applicable License: MD5 (Manufacturing License for Class A devices)
- Licensing Authority: State Licensing Authority
Manufacturing License Process (MD5) for Class A Devices
- Apply for Test License (Form MD13): Before the MD5 license, obtain a test license allowing product testing. This step takes approximately 1.5 to 2 months.
- Product Testing: Submit samples to government-approved laboratories listed on the CDSCO Testing Laboratories page. Typical tests include biocompatibility, antimicrobial efficacy, and material safety.
- Document Preparation: Compile comprehensive documentation, including Device Master File (DMF), Plant Master File (PMF), Risk Management File, and Essential Principles Checklist.
- Application for Manufacturing License (Form MD3): Submit the application via the CDSCO portal.
- Audit by Notified Body: A mandatory audit by a CDSCO-recognized notified body verifies compliance. Find a suitable body on the Notified Bodies List.
- Query Resolution: Address any queries from CDSCO or notified bodies promptly.
- License Issuance (Form MD5): Upon satisfaction, the State Licensing Authority grants the manufacturing license.
Manufacturing License Documents Required
- Company Constitution (Memorandum & Articles of Association)
- Proof of Ownership or Lease of Manufacturing Premises
- List and Qualification Documents of Technical Staff
- Fire NOC and Pollution Control Board NOC
- Device Master File (DMF) — detailing design, manufacturing process, and specifications. Our detailed Device Master File guide can help you prepare.
- Plant Master File (PMF) — outlining facility layout, equipment, and quality systems. Learn more from our Plant Master File guide.
- Essential Principles Checklist confirming compliance with Indian regulations
- Risk Management File demonstrating hazard identification and mitigation strategies (Risk Management Guide)
- Test Reports from approved laboratories
- Product Labels and Instructions for Use (IFU)
- Quality Management System (QMS) documents demonstrating ISO 13485 compliance
Import License Process (MD15) for Antimicrobial Postsurgical Brasieres
If you are an importer, the MD15 license issued by the Central Licensing Authority is required. The process takes approximately 5-6 months and involves:
- Document preparation including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485 certificate, CE Certificate if applicable
- Submission of application on the CDSCO MD Online Portal
- Resolution of any queries
Please refer to our comprehensive Import License Guide for detailed steps.
Import License Documents Required
- Valid Manufacturing License from the exporting country
- Free Sale Certificate
- ISO 13485:2016 Certification
- CE Certificate (if applicable)
- Device Master File and Plant Master File
- Wholesale License
- Company Constitution
Timeline and Processing Duration
| Step | Duration (Approx.) |
|---|---|
| Test License (MD13) | 1.5 – 2 months |
| Product Testing | 1 month |
| Document Preparation | 2 – 3 weeks |
| MD5 License Application (MD3) | 1 – 2 weeks (submission) |
| Audit by Notified Body | 3 – 4 weeks |
| Query Resolution & Granting | 2 – 3 weeks |
Total estimated time: 3 to 4 months
Government Fees and Costs
- Test License Fee (MD13): Included in the process, generally nominal
- MD5 License Application Fee: Rs. 5,000 per application
- Additional Fee: Rs. 500 per product variant
Budget for external audits, product testing fees, and documentation support accordingly.
Common Challenges and Solutions
Challenge: Delays in test report submissions due to laboratory backlogs.
Solution: Engage with accredited labs early and submit samples promptly. Pre-book testing slots if possible.
Challenge: Incomplete documentation causing queries.
Solution: Use our checklists and templates for DMF and PMF preparation to ensure completeness and compliance.
Challenge: Audit non-conformities.
Solution: Conduct internal pre-audits and training with your quality team to minimize observations.
Expert Consultation and Support
Navigating CDSCO licensing can be complex. Our team of experts guides you through every step—from pre-application audits, document preparation, to post-submission query handling—ensuring smooth and timely approvals. We also provide tailored training on regulatory updates and quality systems.
Getting Started with Your CDSCO License Application
- Register your organization on the CDSCO MD Online Portal.
- Initiate the Test License (MD13) application immediately to reduce overall timelines.
- Simultaneously prepare your Device and Plant Master Files using our expert guides.
- Engage with a notified body early for audit scheduling.
- Plan product testing with accredited labs promptly after test license approval.
- Consult with regulatory experts to review your documentation before submission.
By following a structured approach and leveraging expert insights, manufacturers of the Antimicrobial Postsurgical Brassiere can confidently achieve CDSCO compliance and successfully enter India’s growing medical device market.
For personalized support and detailed assistance, connect with our regulatory consultants today and take the first step toward licensing success.
