CDSCO License for Oral medicine dropper

Comprehensive Guide to CDSCO Licensing for Oral Medicine Droppers (Class A Medical Device)

Oral medicine droppers are essential pediatric medical devices designed to precisely dispense liquid medicines in single drops, especially for infants and small children. Typically made of glass or plastic with a rubber teat, these reusable droppers play a crucial role in neonatal and pediatric care by ensuring accurate dosing and safety. Given their medical purpose and reusability, regulatory compliance under the Central Drugs Standard Control Organization (CDSCO) is mandatory for manufacturers and importers aiming to enter the Indian market.

With over 25 years of expertise and 500+ successful CDSCO license approvals, we provide detailed insights and practical guidance on navigating the licensing process specifically for Class A devices like the oral medicine dropper.

CDSCO Regulatory Framework for Oral Medicine Droppers

The oral medicine dropper falls under the pediatric and neonatology device category and is classified as a Class A medical device by CDSCO. Class A devices are considered low risk but still require adherence to the regulatory framework under the Medical Device Rules (MDR), 2017. This framework ensures that all devices meet safety, efficacy, and quality standards before they are marketed in India.

The key regulatory steps include obtaining a Test License (Form MD13), conducting product testing in government-approved laboratories, completing document submissions including Device Master File and Plant Master File, and undergoing an audit by a notified body before the manufacturing license (MD5) is granted by the State Licensing Authority.

For detailed device classification criteria, manufacturers can refer to the Medical Device Classification guide.

Risk Classification and License Requirements for Oral Medicine Droppers

• Risk Class: A (Low risk)
• License Required: Manufacturing License MD5 (for Class A and B devices)
• Approval Authority: State Licensing Authority
• Applicable Forms:
  • Test License: MD13
  • Manufacturing License Application: MD3
  • License Grant: MD5

Being a Class A device, the oral medicine dropper requires a relatively streamlined process compared to higher-risk devices but still demands comprehensive documentation and compliance.

Manufacturing License Process (MD5) for Oral Medicine Droppers

Step 1: Apply for Test License (Form MD13)

Before initiating the manufacturing license process, manufacturers must obtain a Test License on Form MD13. This license allows product samples to be sent for testing in government-approved laboratories.

• Timeline: Approximately 1.5 to 2 months
• Purpose: Enables product testing to verify compliance with essential principles and safety requirements

Step 2: Product Testing

Testing must be conducted at CDSCO-recognized laboratories to validate device safety and efficacy. For oral medicine droppers, tests typically include material biocompatibility, structural integrity, and performance tests.

• Check available labs on the CDSCO Testing Laboratories list.

Step 3: Document Preparation

Prepare comprehensive documents including:

• Company Constitution and Ownership Proof
• Documents of Technical Staff
• Fire and Pollution NOCs
• Device Master File (DMF) and Plant Master File (PMF)
• Essential Principles Checklist
• Risk Management File
• Product Test Reports
• Labels and Instructions for Use (IFU)
• Quality Management System (QMS) Documents

Refer to our detailed Device Master File guide and Plant Master File guide for document preparation.

Step 4: Apply for Manufacturing License (Form MD3)

Submit your manufacturing license application through the CDSCO MD Online Portal.

Step 5: Audit by Notified Body

A mandatory audit of the manufacturing site and QMS is conducted by a notified body listed on the CDSCO Notified Bodies List.

Step 6: Resolution of Queries

Respond promptly to any queries raised by CDSCO officers or the notified body to avoid delays.

Step 7: Grant of Manufacturing License (Form MD5)

Upon successful audit and document review, the State Licensing Authority grants the MD5 license.

Manufacturing License Documents Required for Oral Medicine Droppers

• Company Constitution (MOA, AOA, or Partnership Deed)
• Proof of Ownership or Lease Agreement of Premises
• Qualification and Experience Certificates of Technical Staff
• Fire NOC and Pollution Control Board NOC
• Device Master File (including design, materials, intended use)
• Plant Master File (manufacturing site details, equipment, processes)
• Essential Principles Checklist (demonstrating compliance with MDR)
• Risk Management File (hazard identification and mitigation for reusable devices)
• Test Reports from Government-Approved Labs
• Labels and Instructions for Use (IFU) compliant with CDSCO guidelines
• Quality Management System Documents (ISO 13485:2016 recommended)

Import License Process (MD15) for Oral Medicine Droppers

For importers of oral medicine droppers, an Import License (MD15) issued by the Central Licensing Authority is mandatory.

Key Steps:

• Prepare requisite documents including Manufacturing License from country of origin, Free Sale Certificate, ISO 13485:2016 certificate, CE Certificate, Device Master File, Plant Master File, Wholesale License, and Company Constitution.
• Apply on the CDSCO MD Online Portal.
• Respond to departmental queries during processing.
• License granted on Form MD15.

Timeline: Approximately 5-6 months

Government Fees:

• Class A devices: $1000 per site +$50 per product

For detailed guidance, see our Import License guide.

Timeline and Processing Duration for Oral Medicine Droppers (Class A)

Government Fees and Costs

• Test License (MD13): Rs. 5000 (approx.)
• Manufacturing License (MD5): Rs. 5000 per application + Rs. 500 per product
• Notified body audit fees vary (typically Rs. 50,000 - Rs. 1,00,000 depending on scope)

Budgeting for notified body audits and external testing is critical. Early engagement with these entities can optimize timelines and costs.

Common Challenges and Solutions

• Incomplete Documentation: Ensure all technical and legal documents are complete and updated. Use checklists to avoid missing items.
• Testing Delays: Engage recognized labs early and schedule tests promptly.
• Audit Non-compliance: Prepare through pre-audit reviews and QMS readiness checks.
• Query Backlogs: Maintain prompt communication with CDSCO officers and the notified body.

Our experience with over 500 companies highlights the importance of a proactive approach and thorough preparation to mitigate these challenges.

Expert Consultation and Support

Navigating the CDSCO regulatory landscape can be complex, especially for first-time manufacturers or importers of pediatric devices. Our seasoned consultants provide end-to-end support including:

• Gap analysis and readiness assessment
• Document drafting and review
• Liaison with notified bodies and testing labs
• Application filing and follow-up
• Training on compliance and post-license obligations

Partnering with experts ensures a smoother, faster pathway to market entry.

Getting Started with Your CDSCO License Application for Oral Medicine Droppers

1. Assess Device Classification: Confirm the oral medicine dropper’s Class A status using CDSCO guidance.
2. Compile Required Documents: Begin gathering company and technical documents, including Device and Plant Master Files.
3. Apply for Test License: Submit Form MD13 via the CDSCO MD Online Portal.
4. Schedule Product Testing: Coordinate with government-approved labs early.
5. Prepare for Audit: Engage a notified body for pre-audit consultation.
6. Submit Manufacturing License Application: File Form MD3 once testing and documentation are complete.
7. Monitor and Respond: Stay responsive to any CDSCO queries to expedite approval.

Starting early and following a structured plan significantly increases your chances of timely license approval. Contact us today to leverage our 25+ years of regulatory expertise and accelerate your product’s entry into the Indian healthcare market.