CDSCO License for Contraceptive sponge
Medical Device Information
Intended Use
Bubble like device works as a physical barrier to prevent spermatic invasion into uterus.
Understanding Contraceptive Sponges and Their Regulatory Importance in India
Contraceptive sponges, classified under Class C medical devices, serve as a physical barrier preventing sperm from entering the uterus. As a gynecological device, these sponges play a crucial role in family planning and reproductive health. Due to their intimate use and potential impact on human health, regulatory compliance with the Central Drugs Standard Control Organization (CDSCO) is mandatory before manufacturing or importing contraceptive sponges into India. Our 25+ years of experience in medical device licensing has enabled over 500 companies to navigate the CDSCO regulatory framework with ease.
CDSCO Regulatory Framework for Contraceptive Sponges (Class C Devices)
The CDSCO oversees the regulation of all medical devices in India under the Medical Devices Rules, 2017. Contraceptive sponges fall under Class C, indicating a moderate to high risk based on their intended use and potential impact. As a result, manufacturers must obtain an MD9 manufacturing license granted by the Central Licensing Authority, and importers must secure an MD15 import license. Compliance ensures safety, efficacy, and quality, safeguarding end-users and meeting statutory requirements.
Risk Classification and License Requirements for Contraceptive Sponges
Contraceptive sponges are categorized as Class C devices due to their direct interaction with the reproductive system and barrier function. This classification necessitates stringent controls, including:
- MD9 Manufacturing License: For Indian manufacturers, issued by CDSCO Central Licensing Authority.
- MD15 Import License: For importers, also issued centrally.
Understanding these license types is essential for timely compliance and market entry.
Step-by-Step MD9 Manufacturing License Process for Contraceptive Sponges
- Apply for Test License (Form MD13): Initiate by obtaining a test license, valid for 6 months, allowing product testing in CDSCO-recognized laboratories.
- Product Testing: Submit samples to government-approved labs listed on the CDSCO Testing Laboratories page for compliance verification.
- Documentation Preparation: Assemble all required documents including Device Master File, Plant Master File, Essential Principles Checklist, and Risk Management File.
- Application Submission (Form MD7): File the MD9 manufacturing license application on the CDSCO MD Online Portal.
- Audit by CDSCO Inspectors: Prepare for a detailed audit covering QMS, premises, and technical staff qualifications.
- Respond to Queries: CDSCO may raise technical or compliance queries; prompt resolution is critical.
- License Grant (Form MD9): Upon successful audit and document verification, the manufacturing license is granted.
For an in-depth guide, visit our MD9 License Guide.
Essential Documents Required for MD9 License Application
- Company Constitution (Incorporation Certificate)
- Proof of Premises Ownership or Lease Agreement
- Technical Staff Qualification & Experience Records
- Fire NOC and Pollution Control Board NOC
- Device Master File (DMF) detailing design, manufacturing, and safety (Device Master File Guide)
- Plant Master File (PMF) describing manufacturing facility (Plant Master File Guide)
- Essential Principles Compliance Checklist
- Risk Management File based on ISO 14971 (Risk Management)
- Test Reports from CDSCO-approved labs
- Product Labels and Instructions for Use (IFU)
- Quality Management System Documents (ISO 13485:2016 certification recommended)
Import License (MD15) Process for Contraceptive Sponges
Importers of contraceptive sponges must follow these steps:
- Document Compilation: Collect all required certificates including manufacturing license, Free Sale Certificate, ISO 13485:2016, CE Certificate, DMF, PMF, and Wholesale License.
- Application Submission: File Form MD14 for MD15 license through the CDSCO MD Online Portal.
- Department Review: CDSCO will examine documents and may raise queries.
- License Issuance: Upon satisfactory review, MD15 import license is granted.
We recommend consulting our detailed Import License Guide for tailored assistance.
Documents Checklist for MD15 Import License
- Valid Manufacturing License (MD9 or equivalent)
- Free Sale Certificate from country of origin
- ISO 13485:2016 Certificate
- CE Certificate (if applicable)
- Device Master File
- Plant Master File
- Wholesale License for distribution
- Company Constitution
Timeline and Processing Duration
| License Type | Process Duration | Key Milestones |
|---|---|---|
| MD9 Manufacturing License (Class C) | 4-5 months | Test license (1.5-2 months), Testing, Audit, Query resolution, License grant |
| MD15 Import License | 5-6 months | Document preparation, Application review, Query resolution, License grant |
Delays often arise due to incomplete documentation or slow responses to CDSCO queries. Early preparation and expert guidance can mitigate such risks.
Government Fees and Costs for Contraceptive Sponges
- MD9 Manufacturing License:
- Application fee: ₹50,000
- Per product fee: ₹1,000
- MD15 Import License:
- Site fee (Class C): $3,000 approx.
- Per product fee: $1,500 approx.
Note: Fees are subject to change; always verify on the CDSCO MD Online Portal.
Common Challenges and Practical Solutions
- Incomplete Documentation: Maintain a comprehensive checklist and cross-verify all documents before submission.
- Delays in Product Testing: Choose accredited testing labs early; plan sample submission timelines accordingly.
- Audit Non-compliance: Conduct internal audits and gap assessments prior to CDSCO inspections.
- Query Management: Assign dedicated personnel for timely and accurate responses.
Our team’s experience with over 500 successful CDSCO licensing projects ensures practical strategies to overcome these hurdles.
Expert Consultation and Support
Navigating CDSCO’s regulatory processes for Class C devices like contraceptive sponges can be complex. We offer end-to-end consultancy, from document preparation to audit readiness and query handling, ensuring a seamless licensing journey. Our proven track record and deep understanding of CDSCO norms empower manufacturers and importers to accelerate market entry.
Getting Started with Your CDSCO License Application
- Assess Your Device Classification: Confirm contraceptive sponges as Class C using the Medical Device Classification resource.
- Gather Preliminary Documents: Begin compiling your company, technical, and product documentation.
- Apply for Test License (Manufacturers): Submit Form MD13 via the CDSCO MD Online Portal.
- Select Testing Laboratory: Choose from the official list of testing labs.
- Prepare for Audit: Engage a notified body or CDSCO inspectors, depending on license type.
- Submit License Application: Apply for MD9 (manufacturing) or MD15 (import) license through the CDSCO portal.
Leveraging our consultancy services can expedite these steps with expert documentation review, audit preparation, and regulatory compliance support. Connect with us today to ensure your contraceptive sponge reaches the Indian market compliantly and efficiently.
