CDSCO License for Contraceptive cervical cap, reusable or single use
Medical Device Information
Intended Use
Device inserted into the cervix to prevent semen from entering the uterus.
Comprehensive Guide to CDSCO Licensing for Contraceptive Cervical Caps (Class C Medical Device)
Manufacturers and importers of contraceptive cervical caps — reusable or single-use devices designed to prevent semen from entering the uterus — must navigate the rigorous regulatory framework of India's Central Drugs Standard Control Organization (CDSCO). Classified as a Class C medical device under the obstetrical and gynecological category, this device requires precise adherence to CDSCO licensing procedures to ensure market authorization.
With over 25 years of regulatory consulting experience and having supported 500+ companies in securing CDSCO approvals, we provide a detailed, step-by-step guide tailored specifically for contraceptive cervical caps, including timelines, costs, documentation, and common challenges.
CDSCO Regulatory Framework for Contraceptive Cervical Caps
Contraceptive cervical caps fall under Class C according to CDSCO's risk classification due to their invasive nature and critical role in reproductive health. This classification mandates a manufacturing license from the Central Licensing Authority (MD9) and an import license (MD15) for imported devices. The regulatory framework ensures that these devices meet quality, safety, and efficacy standards before entering the Indian market.
The device is regulated following the notification File No. 29/Misc./03/2020-DC (181), dated 03.06.2022, which explicitly includes contraceptive cervical caps under Class C medical devices.
Risk Classification and License Requirements
- Risk Class: C (Moderate to High Risk)
- License Type for Manufacturing: MD9 (Form MD7)
- License Type for Import: MD15 (Form MD14)
- Authority: Central Licensing Authority (CDSCO HQ, New Delhi)
Class C devices require rigorous compliance, including clinical evaluation, quality management systems aligned with ISO 13485:2016, and comprehensive documentation.
Manufacturing License Process (MD9) for Contraceptive Cervical Caps
The MD9 license process is multi-staged and takes approximately 4-5 months from initial application to approval:
- Test License Application (Form MD13): Before applying for the MD9 license, manufacturers must obtain a Test License, which typically takes 1.5-2 months. This allows product testing in government-approved laboratories.
- Product Testing: Testing must be conducted at CDSCO-recognized labs to verify compliance with Indian standards. Refer to the Testing Laboratories list for approved facilities.
- Document Preparation: Prepare a comprehensive dossier including Device Master File, Plant Master File, Essential Principles checklist, Risk Management File, and clinical evaluation reports.
- Application Submission: Submit Form MD7 via the CDSCO MD Online Portal.
- Audit: CDSCO inspectors will audit your manufacturing facility and documentation.
- Query Resolution: Address any clarifications or deficiencies raised by CDSCO.
- License Grant: Upon successful audit and document verification, the MD9 license is granted.
Manufacturing License Documents Required
For contraceptive cervical caps (Class C), the following documents are mandatory:
- Company constitution and incorporation certificates
- Proof of ownership or lease of manufacturing premises
- Technical staff qualifications and experience
- Fire safety and pollution control certificates
- Device Master File (DMF) – Detailed design and manufacturing process (Device Master File guide)
- Plant Master File (PMF) – Details of manufacturing site and quality controls (Plant Master File guide)
- Essential Principles Checklist confirming compliance with Indian regulations
- Risk Management File documenting hazard analysis and mitigation (Risk Management)
- Test Reports from government-approved labs
- Product labels and Instructions for Use (IFU)
- Quality Management System (QMS) documentation compliant with ISO 13485:2016
Import License Process (MD15) for Contraceptive Cervical Caps
Importers must secure an MD15 license from CDSCO’s Central Licensing Authority. The process takes roughly 5-6 months and involves:
- Document Compilation: Prepare dossiers including manufacturing license, Free Sale Certificate from the country of origin, ISO 13485:2016 certification, CE Certificate if applicable, Device and Plant Master Files, and wholesale license.
- Application Submission: File Form MD14 through the CDSCO MD Online Portal.
- Query Resolution: Respond to any CDSCO queries promptly.
- License Issuance: Upon satisfactory review, the import license is granted.
Import License Documents Required
- Valid Manufacturing License (MD9 equivalent) from the country of origin
- Free Sale Certificate from exporting country
- ISO 13485:2016 Certification
- CE Certificate (if applicable)
- Device Master File and Plant Master File
- Wholesale License for distribution
- Company constitution and registration details
Timeline and Processing Duration
| License Type | Approximate Duration | Notes |
|---|---|---|
| Test License (MD13) | 1.5 – 2 months | Required for manufacturing license |
| Manufacturing License (MD9) | 4 – 5 months | Includes testing, audit, and query resolution |
| Import License (MD15) | 5 – 6 months | No test license required |
Early preparation of documentation and proactive query management can help expedite approvals.
Government Fees and Costs
| License Type | Application Fee (INR) | Per Product Fee (INR) | Notes |
|---|---|---|---|
| MD9 Manufacturing | 50,000 | 1,000 | Central Authority license fee |
| MD15 Import | $3,000 (approx 2.5 lakh INR) | $1,500 (approx 1.25 lakh INR) | Fees vary by device risk class |
Additional costs include testing fees at government-approved labs and audit fees if outsourced to notified bodies.
Common Challenges and Solutions
- Delayed Testing Reports: Engage early with accredited labs and schedule testing promptly to avoid bottlenecks.
- Incomplete Documentation: Utilize detailed checklists for DMF, PMF, and risk management files to ensure completeness.
- Audit Non-compliance: Conduct internal pre-audits to verify facility and QMS readiness.
- Query Management: Respond comprehensively and within timelines to CDSCO queries to prevent delays.
Expert Consultation and Support
Navigating the CDSCO regulatory landscape for Class C devices like contraceptive cervical caps demands expertise. Our consultancy offers:
- End-to-end application preparation and submission
- Documentation review and gap analysis
- Coordination with notified bodies and testing labs
- Pre-audit readiness assessments
- Post-license compliance guidance
Our proven track record with over 500 successful licenses ensures a smooth and efficient pathway.
Getting Started with Your CDSCO License Application
- Assess Your Device Classification: Confirm your device is Class C under the latest CDSCO guidelines (Medical Device Classification).
- Initiate Test License (MD13): Submit your test license application via the CDSCO MD Online Portal to begin product testing.
- Engage Accredited Labs: Identify suitable government-approved labs for timely testing.
- Compile Comprehensive Documentation: Prepare your Device Master File, Plant Master File, and risk management documentation.
- Submit MD9 Application: Once testing is complete, apply for the manufacturing license through the portal.
- Prepare for Audit: Coordinate with CDSCO inspectors and ensure factory compliance.
- Plan Import Licensing (if applicable): For imports, compile necessary documents and apply for MD15 license.
Embarking early with expert guidance will position your contraceptive cervical cap for successful market entry in India. Contact us to leverage our 25+ years of regulatory expertise and accelerate your CDSCO licensing journey.
