CDSCO License for Nipple shield.

Introduction: Understanding the Nipple Shield and Its Regulatory Importance

A nipple shield is a specialized medical device designed as a protective cover for the nipple of nursing women, aimed at preventing discomfort and facilitating breastfeeding. Classified under General Hospital or Orthopaedic Instruments, nipple shields fall under Class A risk category as per the latest CDSCO notification 29/Misc./03/2020-DC (193)- Part-3 dated 16.03.2022.

Given its direct contact with patients and its medical purpose, proper regulatory compliance is critical. Obtaining the correct CDSCO license ensures your nipple shield device meets Indian safety and quality standards, enabling you to manufacture and market it legally in India. With over 25 years of experience and having successfully supported 500+ companies, we offer an expert roadmap for manufacturers and importers aiming for smooth CDSCO licensing of nipple shields.

CDSCO Regulatory Framework for Nipple Shield Devices

The Central Drugs Standard Control Organization (CDSCO) governs medical device regulation in India. Since nipple shields are classified as Class A devices under the General Hospital or Orthopaedic Instruments category, their regulation falls under the purview of the State Licensing Authorities. This classification aligns with the low-risk profile of the device.

To manufacture nipple shields in India, obtaining an MD5 manufacturing license is mandatory. For imports, an MD15 import license issued by the Central Licensing Authority is required.

Risk Classification and License Requirements for Nipple Shields

• Risk Class: Class A (Low risk)
• License Type: MD5 (Manufacturing License)
• Regulatory Authority: State Licensing Authority
• Governing Notification: 29/Misc./03/2020-DC (193)- Part-3

Class A devices like nipple shields have simplified regulatory pathways but still require robust documentation and compliance to ensure safety and quality.

Manufacturing License Process (MD5) for Nipple Shields

The MD5 license process for nipple shield manufacturing involves multiple defined steps:

1. Test License (Form MD13): Apply for a test license to conduct product testing. This process typically takes 1.5 to 2 months.
2. Product Testing: Get your nipple shield tested at government-approved laboratories to verify safety and compliance.
3. Documentation Preparation: Compile all required documents including Device Master File, Plant Master File, QMS, Risk Management File, and more.
4. Application Submission (Form MD3): Submit the formal MD5 manufacturing license application through the CDSCO MD Online Portal.
5. Audit by Notified Body: Undergo an audit by a notified body listed by CDSCO to verify compliance with manufacturing and quality standards. Find the list of notified bodies here.
6. Query Resolution: Address any queries or observations raised by the department or the notified body.
7. License Grant (Form MD5): Upon satisfactory completion, the manufacturing license is granted.

The entire process generally spans 3 to 4 months.

Manufacturing License Documents Required for Nipple Shields

To expedite your MD5 application for nipple shields, prepare the following comprehensive documentation:

• Company Constitution (Incorporation Certificate, Partnership Deed, etc.)
• Proof of ownership or lease of manufacturing premises
• Details and qualifications of technical staff
• Fire Safety NOC
• Pollution Control NOC
• Device Master File (DMF): Detailed product specifications and design controls (Our detailed Device Master File guide can help you prepare this document.)
• Plant Master File (PMF): Manufacturing site details and quality systems (Plant Master File Guide)
• Essential Principles Checklist confirming conformity with Indian medical device regulations
• Risk Management File demonstrating hazard identification and mitigation (Risk Management Guide)
• Test Reports from government-approved labs (Approved Testing Laboratories)
• Product labels and Instructions for Use (IFU)
• Quality Management System (QMS) documentation, preferably ISO 13485 compliant

Ensuring your documentation is complete and accurate is critical to avoid delays.

Import License Process (MD15) for Nipple Shields

If you intend to import nipple shields into India, an MD15 import license from the Central Licensing Authority is mandatory. The process includes:

• Document preparation including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016 Certificate, CE Certificate if applicable, and Device and Plant Master Files.
• Application submission on the CDSCO MD Online Portal.
• Review by CDSCO and resolution of queries.
• License issuance typically takes 5 to 6 months.

Note: Unlike manufacturing, test license (MD13) is not required for imports.

Import License Documents Required for Nipple Shields

Key documents include:

• Valid manufacturing license from the exporting country
• Free Sale Certificate issued by competent authority
• ISO 13485:2016 certification
• CE Certificate (if applicable)
• Device Master File and Plant Master File
• Wholesale Drug License (if applicable)
• Company Constitution documents

Preparing these documents in advance can streamline your application.

Timeline and Processing Duration for Nipple Shield Licensing

For imports (MD15), expect 5 to 6 months total.

Government Fees and Costs for Nipple Shield Licensing

• MD5 Manufacturing License Fees:

  • Application Fee: Rs. 5,000
  • Per Product Fee: Rs. 500

• Test License (MD13) Fees: Included in the MD5 process

• Import License (MD15) Fees:

  • Class A devices: Approx. $1,000 per site +$50 per product

Budgeting for these fees upfront avoids surprises during application.

Common Challenges and Solutions in Nipple Shield CDSCO Licensing

• Incomplete Documentation: Missing or inconsistent Device Master Files or Risk Management Files can cause delays. Solution: Engage experts to review and prepare these critical documents.

• Delayed Product Testing: Testing labs may have backlogs. Solution: Schedule tests early and choose approved labs with reasonable turnarounds.

• Audit Non-compliance: Facilities or processes not meeting notified body standards lead to audit failures. Solution: Conduct internal audits and pre-checks before official audits.

• Query Backlogs: Delayed responses to CDSCO queries stall approvals. Solution: Have a dedicated compliance team for timely and thorough responses.

• Confusion on Licensing Authority: Manufacturers sometimes apply to incorrect authorities. Solution: Remember, Class A devices require state-level MD5 licensing, not central.

Expert Consultation and Support for CDSCO Licensing

Navigating CDSCO regulatory pathways can be complex. Our consultancy, with over 25 years of experience and a track record of 500+ successful client licenses, offers tailored support including:

• End-to-end application preparation and submission on the CDSCO MD Online Portal
• Document drafting and review (DMF, PMF, Risk Management Files)
• Coordination with notified bodies and testing labs
• Pre-audit readiness assessments
• Prompt resolution of regulatory queries

Engaging expert consultants significantly reduces time to market and mitigates compliance risks.

Getting Started with Your CDSCO License Application for Nipple Shields

1. Classify Your Device: Confirm nipple shield as Class A under the latest CDSCO notification.
2. Apply for Test License (MD13): Initiate testing process to validate product safety.
3. Identify Approved Testing Lab: Select an approved lab from the CDSCO Testing Laboratories list.
4. Prepare Documentation: Compile Device Master File, Plant Master File, Risk Management File, and other mandatory documents.
5. Schedule Audit: Coordinate with a notified body for the MD5 audit (see the Notified Bodies list).
6. Submit Application: File your MD5 application via the CDSCO MD Online Portal.
7. Maintain Communication: Respond swiftly to any queries from CDSCO or notified bodies.

Starting with these actionable steps will set you on a clear path to obtain your manufacturing license for nipple shields in India efficiently and compliantly.

For personalized guidance and to expedite your CDSCO licensing process, connect with our expert team today. Together, we can ensure your nipple shield device meets all regulatory requirements and reaches the Indian market without delay.