CDSCO License for Insulin Syringes

Comprehensive Guide to CDSCO Licensing for Insulin Syringes (Class B Medical Device)

Insulin syringes play a critical role in diabetes management by providing a safe, precise method of insulin administration. As a disposable hypodermic syringe categorized under Class B devices per CDSCO's regulatory framework, obtaining the appropriate license is mandatory for manufacturers and importers to legally market these syringes in India. With over 25 years of experience and having assisted 500+ companies, we offer you a detailed roadmap to navigate the CDSCO licensing process efficiently.

CDSCO Regulatory Framework for Insulin Syringes

The Central Drugs Standard Control Organization (CDSCO) regulates medical devices under the Medical Device Rules, 2017, which came into effect on January 1, 2018. Insulin syringes fall under the notification number 29/Misc/3/2017-DC (292) dated June 6, 2018, classifying them as Class B devices due to their low-to-moderate risk profile.

The regulatory framework focuses on ensuring safety, quality, and efficacy by mandating manufacturers to obtain a manufacturing license (MD5) issued by the State Licensing Authority.

Risk Classification and License Requirements for Insulin Syringes

Device: Insulin Syringes

Risk Class: B (Low-moderate risk)

License Type: Manufacturing License (MD5)

Governing Authority: State Licensing Authority

Class B devices require a thorough approval process involving product testing, documentation, and an audit by a notified body before the license is granted.

For a detailed understanding of classification, you may refer to our Medical Device Classification guide.

Manufacturing License Process (MD5) for Insulin Syringes

The MD5 license process typically spans 3 to 4 months and involves the following key steps:

1. Test License Application (Form MD13): Obtain a test license valid for 1.5 to 2 months, which allows you to conduct product testing.
2. Product Testing: Conduct mandatory testing at a CDSCO-approved laboratory to verify compliance with essential principles.
3. Documentation Preparation: Compile all required documents including Device Master File (DMF), Plant Master File (PMF), and Risk Management File.
4. License Application Submission (Form MD3): Apply for the manufacturing license through the CDSCO MD Online Portal.
5. Audit by Notified Body: A notified body listed on CDSCO’s Notified Bodies List will conduct a site audit.
6. Query Resolution: Address any queries raised by the licensing authority or notified body.
7. License Grant (Form MD5): Upon satisfactory compliance, the manufacturing license is granted.

Manufacturing License Documents Required

For Insulin Syringes (Class B), prepare the following documentation meticulously:

• Company Constitution and Registration Proof
• Proof of Ownership or Lease Agreement of Manufacturing Premises
• Qualification and Experience Details of Technical Staff
• Fire NOC and Pollution Control NOC
• Device Master File (DMF) – covering product specifications, design, manufacturing process, and labeling. Learn more from our Device Master File guide.
• Plant Master File (PMF) – detailing infrastructure, machinery, quality control systems. For detailed steps, see our Plant Master File guide.
• Essential Principles Checklist aligned with Medical Device Rules
• Risk Management File documenting hazard analysis and mitigation strategies, available in our Risk Management guide.
• Test Reports from CDSCO-approved labs (Testing Laboratories)
• Labels and Instructions for Use (IFU)
• Quality Management System (QMS) Documents such as ISO 13485:2016 certification

Import License Process (MD15) for Insulin Syringes

Importers of insulin syringes must obtain an MD15 import license granted by the Central Licensing Authority. This process generally takes 5 to 6 months.

The steps include:

1. Preparation of import-related documents such as Free Sale Certificate, ISO 13485:2016, CE Certificate.
2. Submission of application on Form MD14 through the CDSCO MD Online Portal.
3. Resolution of any departmental queries.
4. Grant of the import license (Form MD15).

Required documents include Manufacturing License, Free Sale Certificate, ISO 13485:2016, CE Certificate, Device Master File, Plant Master File, Wholesale License, and Company Constitution.

Timeline and Processing Duration

Our extensive experience shows that early and thorough preparation of documents and proactive communication with the licensing authority significantly reduce delays.

Government Fees and Costs

For Class B devices like insulin syringes, the fee structure is as follows:

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

Additional costs may include fees for product testing, notified body audits, and consultancy services if you choose expert assistance.

Common Challenges and Solutions

Challenge: Delays in product testing due to limited slots at government-approved labs.

Solution: Schedule testing well in advance and consider multiple approved labs from the CDSCO Testing Laboratories list.

Challenge: Incomplete or inconsistent documentation leading to audit queries.

Solution: Utilize pre-audit checklists and consult with regulatory experts to ensure compliance.

Challenge: Audit non-conformities on technical staff qualification or facility standards.

Solution: Ensure your technical team meets the required qualifications and your facility complies with Good Manufacturing Practices (GMP).

Expert Consultation and Support

Navigating the CDSCO licensing process for insulin syringes can be complex, but with our 25+ years of experience and a track record of helping over 500 companies, we provide tailored guidance, document preparation, audit support, and liaison services with regulatory authorities to ensure a smooth approval process.

We recommend engaging expert consultants early to avoid costly delays and ensure adherence to all regulatory requirements.

Getting Started with Your CDSCO License Application

1. Assess Device Classification: Confirm insulin syringes are Class B devices under CDSCO regulations.
2. Register on the CDSCO MD Online Portal: Create your account and familiarize yourself with the submission process.
3. Initiate Test License Application (Form MD13): Prepare preliminary documents and apply for the test license.
4. Coordinate Product Testing: Select a CDSCO-approved lab from the Testing Laboratories list.
5. Compile Comprehensive Documentation: Develop DMF, PMF, Risk Management File, and QMS documents.
6. Schedule Notified Body Audit: Identify notified bodies from the Notified Bodies List and arrange an audit.
7. Submit Manufacturing License Application (Form MD3): Upload all documents and proceed with application.
8. Prepare for and Respond to Queries: Maintain prompt communication with the authorities.

Taking these actionable steps will significantly enhance your chances of timely approval and market entry in India.

For a detailed walkthrough of the MD5 license process tailored for Class A and B devices like insulin syringes, visit our MD5 License Guide.

We invite you to contact us for personalized assistance in your CDSCO licensing journey to ensure compliance and successful market penetration.