CDSCO License for Sharps Injury Protection (SIP) - Plastic needle shield  to be added to a syringe

Comprehensive Guide to CDSCO Licensing for Sharps Injury Protection (SIP) Plastic Needle Shields (Class B Medical Device)

With over 25 years of regulatory expertise and 500+ successful client engagements, we understand the intricacies involved in obtaining CDSCO licenses for medical devices like the Sharps Injury Protection (SIP) plastic needle shield. This device, classified as Class B under CDSCO regulations, is a disposable hypodermic syringe accessory intended to inject or withdraw fluids safely by minimizing needle-stick injuries. Navigating the regulatory framework effectively ensures timely market entry while maintaining compliance with Indian medical device laws.

CDSCO Regulatory Framework for Sharps Injury Protection Devices

The Central Drugs Standard Control Organization (CDSCO) regulates medical devices under the Medical Device Rules, 2017. The SIP plastic needle shield falls under the notified category "Disposable Hypodermic Syringes" with Notification Number 29/Misc/3/2017-DC (292), dated 06.06.2018. This classification mandates adherence to specific licensing protocols, quality standards, and testing requirements before commercial distribution in India.

Risk Classification and License Requirements for Class B Devices

According to CDSCO's risk classification, Class B devices are low to moderate risk. The SIP plastic needle shield is categorized here due to its role as a safety accessory to syringes. Manufacturers of Class B devices are required to obtain an MD5 manufacturing license issued by the State Licensing Authority. The MD5 license process involves rigorous documentation, testing, and audit procedures to ensure product safety and quality.

For detailed classification guidance, refer to the Medical Device Classification resource.

Manufacturing License Process (MD5) for Sharps Injury Protection Devices

The MD5 license application process includes the following key steps:

1. Apply for a Test License (Form MD13): Before full licensing, manufacturers must obtain a test license to legally produce the device for testing purposes. This typically takes 1.5 to 2 months.

2. Product Testing: Conduct mandatory testing at CDSCO-approved laboratories to validate product safety and performance. Refer to the Testing Laboratories list.

3. Document Preparation: Prepare comprehensive technical and quality documentation including Device Master File (DMF), Plant Master File (PMF), Essential Principles Checklist, Risk Management File, QMS documents, and product labeling.

4. Application Submission: Submit the MD5 license application (Form MD3) through the CDSCO MD Online Portal.

5. Audit by Notified Body: An audit by a CDSCO-notified body is conducted to assess compliance. Find the list of notified bodies.

6. Query Resolution: Address any queries raised during audit or review.

7. License Grant: Upon successful review and audit, the MD5 license (Form MD5) is issued.

For a step-by-step process, see our detailed MD5 License Guide.

Manufacturing License Documents Required

The documentation package for the SIP plastic needle shield includes:

• Company Constitution or Incorporation Certificate
• Proof of Ownership or Lease Agreement for Manufacturing Premises
• Qualification & Experience Certificates of Technical Staff
• Fire Safety NOC
• Pollution Control Board NOC
• Device Master File (DMF) – covering design, specifications, and manufacturing process (Guide here)
• Plant Master File (PMF) – detailing facility infrastructure (Guide here)
• Essential Principles Compliance Checklist
• Risk Management File – hazard analysis and mitigation strategies (Risk Management insights)
• Test Reports from CDSCO-approved labs
• Labels and Instructions for Use (IFU)
• Quality Management System (QMS) Documents (ISO 13485:2016 compliant preferred)

Ensuring accuracy and completeness in these documents significantly reduces processing delays.

Import License Process (MD15) for SIP Plastic Needle Shields

If you intend to import SIP plastic needle shields into India, the MD15 import license is required. The process involves:

• Document preparation including manufacturing license, Free Sale Certificate, ISO 13485 certification, CE marking (if applicable), DMF, PMF, and wholesale licenses.
• Application submission via Form MD14 on the CDSCO MD Online Portal.
• Resolution of departmental queries.
• License grant on Form MD15, typically within 5-6 months.

For more detailed guidance, visit our Import License Guide.

Timeline and Processing Duration

• Test License (MD13): 1.5 to 2 months
• Product Testing: 3 to 4 weeks (parallel with document preparation)
• Audit and Review: 1 to 1.5 months
• Overall MD5 License: Approximately 3 to 4 months from application submission

Timelines can vary based on document readiness, audit scheduling, and query resolution speed.

Government Fees and Costs

• Application Fee: Rs 5,000 per MD5 application
• Product-wise Fee: Rs 500 per product

Additional costs include testing fees at approved labs, audit fees payable to notified bodies, and consultancy fees if you engage experts.

Common Challenges and Solutions

• Incomplete Documentation: Missing or inconsistent technical files cause delays. Solution: Follow a comprehensive checklist and perform internal audits before submission.
• Delayed Test Reports: Lab backlogs can postpone testing. Solution: Engage with CDSCO-approved labs early and confirm testing schedules.
• Non-Compliance during Audit: Audit findings can lead to rework. Solution: Conduct pre-audit mock inspections to ensure facility and process readiness.
• Query Management: Slow response to CDSCO queries extends approval time. Solution: Assign dedicated personnel for prompt communication.

Expert Consultation and Support

Engaging regulatory consultants with proven CDSCO experience can streamline your licensing journey. Our team has successfully guided over 500 companies through the MD5 application process, ensuring compliance and timely approvals. We offer:

• Gap analysis of your documentation and QMS
• Coordination with approved testing laboratories
• Audit preparation and post-audit support
• Liaison with CDSCO authorities for swift query resolution

Getting Started with Your CDSCO License Application

To initiate your MD5 license application for the Sharps Injury Protection plastic needle shield:

1. Register on the CDSCO MD Online Portal.
2. Prepare and submit the Test License application (Form MD13).
3. Simultaneously, set up testing with a CDSCO-approved laboratory.
4. Compile and validate all required documents, including DMF and PMF.
5. Upon receiving test license, manufacture samples for testing and complete lab tests.
6. Submit the MD5 license application (Form MD3) after receiving test reports.
7. Prepare for the notified body audit and resolve any queries promptly.

By following this roadmap and leveraging expert guidance, manufacturers can confidently meet CDSCO requirements and successfully launch the SIP plastic needle shield in the Indian market.

For customized assistance, detailed checklists, and audit readiness support, connect with our regulatory consulting team today.