CDSCO License for Traditional single use syringe without safety feature  (Sterile hypodermic syringes for single use)

Comprehensive Guide to CDSCO Licensing for Traditional Single-Use Syringes (Class B)

Introduction: Understanding Your Medical Device and Regulatory Importance

Traditional single-use syringes without safety features—sterile hypodermic syringes intended for injecting or withdrawing fluids—are critical disposable medical devices widely used across healthcare settings. Classified as Class B under CDSCO regulations, these syringes demand stringent compliance to ensure patient safety and meet quality benchmarks. Navigating India's regulatory landscape for such devices is essential for manufacturers aiming to enter or expand within the Indian market.

With over 25 years of experience assisting 500+ companies in securing CDSCO licenses, we understand the complexities manufacturers face—from documentation to audits and timelines. This guide offers an actionable roadmap tailored for Class B disposable hypodermic syringes, aligned with the CDSCO’s notification 29/Misc/3/2017-DC (292) dated 06.06.2018.

CDSCO Regulatory Framework for Traditional Single-Use Syringes

The Central Drugs Standard Control Organization (CDSCO) governs medical device registration and licensing in India. Being a Class B device, the traditional single-use syringe falls under moderate risk, mandating a manufacturing license known as the MD5 license issued by the State Licensing Authority.

Manufacturers must comply with the Medical Devices Rules, 2017, which classify devices based on risk and intended use. The Medical Device Classification guide will further help clarify criteria.

Risk Classification and License Requirements for Single-Use Syringes

• Device: Traditional single-use syringe without safety feature
• Risk Class: B (Moderate Risk)
• Intended Use: Injection or withdrawal of fluids from the body
• Applicable License: MD5 Manufacturing License (Form MD3)
• Regulatory Authority: State Licensing Authority

Class B devices require obtaining a test license (Form MD13) before the final manufacturing license. The process also involves product testing in government-approved labs and an audit by a notified body.

Manufacturing License Process (MD5) for Class B Syringes

The MD5 license process is comprehensive but straightforward when approached methodically:

1. Apply for Test License (Form MD13): Initial license to permit testing of the device. This takes approximately 1.5 to 2 months.
2. Product Testing: Conduct tests at CDSCO-approved laboratories. Refer to the list of testing laboratories for suitable facilities.
3. Documentation Preparation: Compile Device Master File, Plant Master File, Quality Management System (QMS) documents, Risk Management File, Essential Principles Checklist, and other technical dossiers.
4. Apply for Manufacturing License (Form MD3): Submit your application through the CDSCO MD Online Portal.
5. Audit by Notified Body: A notified body audit is mandatory for Class B devices. You can check the list of notified bodies authorized for this audit.
6. Resolution of Queries: Address any observations or queries raised by the CDSCO or notified body promptly.
7. Grant of MD5 License: Upon satisfactory review, the license is granted, allowing manufacturing and sale within India.

Manufacturing License Documents Required for Traditional Single-Use Syringes

To ensure a smooth application process, gather the following essential documents:

• Company Constitution Documents: Incorporation certificate, partnership deed, or LLP agreement.
• Proof of Ownership/Lease of Manufacturing Premises: Valid ownership or lease documents.
• Technical Staff Qualification Proofs: Details and credentials of qualified technical personnel.
• Fire NOC and Pollution Control Board NOC: Compliance certificates from local authorities.
• Device Master File (DMF): Comprehensive technical details of the syringe design and manufacturing process. Our detailed Device Master File guide can assist you.
• Plant Master File (PMF): Description of your manufacturing facility's infrastructure and quality systems. Learn more in our Plant Master File guide.
• Essential Principles Checklist: Declaration of conformity with CDSCO essential principles.
• Risk Management File: Documented risk analysis and mitigation strategies.
• Test Reports: Product testing certificates from CDSCO-approved labs.
• Labels and Instructions for Use (IFU): Samples of product labeling and user manuals.
• Quality Management System Documentation: ISO 13485 compliance documents.

Import License Process (MD15) – Note for Importers

If you plan to import traditional single-use syringes into India, the applicable license is the MD15 Import License, issued by the Central Licensing Authority.

The import license process involves:

• Document preparation including Manufacturing License from the country of origin, Free Sale Certificate, ISO 13485 certificate, CE certificate if applicable.
• Submission of application on the CDSCO MD Online Portal.
• Timely resolution of queries raised by the authority.

The process typically takes 5-6 months, with fees varying based on risk class and product count.

Import License Documents Required

• Valid manufacturing license from the country of origin
• Free Sale Certificate
• ISO 13485:2016 certificate
• CE Certificate or equivalent
• Device Master File and Plant Master File
• Wholesale license in India
• Company Constitution Documents

Timeline and Processing Duration for MD5 License

Timelines may vary depending on document readiness and audit scheduling.

Government Fees and Costs for MD5 License

• Application fee per MD5 license: INR 5,000
• Fee per product included in the license: INR 500

For example, if you apply for a license covering 5 syringe variants, fees will be INR 5,000 + (5 × 500) = INR 7,500.

Additional costs to budget for include product testing fees at approved labs and notified body audit charges.

Common Challenges and Solutions

Challenge: Delays in audit scheduling or product testing.

Solution: Engage early with notified bodies and testing labs to pre-book slots. Maintain clear communication and preparedness to avoid last-minute delays.

Challenge: Incomplete or inconsistent documentation leading to queries.

Solution: Use checklists and expert reviews to ensure all required documents, such as the Device Master File and Risk Management File, are complete and compliant.

Challenge: Non-compliance with essential principles or QMS gaps.

Solution: Conduct internal audits and gap analysis aligned with ISO 13485 and CDSCO guidelines before submission.

Expert Consultation and Support

With 25+ years of regulatory consulting experience, we have helped hundreds of manufacturers successfully navigate CDSCO licensing for Class B devices like traditional single-use syringes. Our support includes:

• End-to-end application preparation
• Audit readiness and liaison with notified bodies
• Tailored gap analysis and training on regulatory compliance
• Assistance with product testing coordination

Partnering with experienced consultants can significantly reduce approval time and increase the likelihood of first-time acceptance.

Getting Started with Your CDSCO License Application

To initiate your journey towards obtaining the MD5 license for traditional single-use syringes:

1. Register on the CDSCO MD Online Portal.
2. Prepare and submit your Test License Application (Form MD13).
3. Coordinate product testing with approved government labs.
4. Compile the comprehensive documentation package, including Device and Plant Master Files.
5. Apply for the MD5 Manufacturing License (Form MD3).
6. Schedule and prepare for the notified body audit.
7. Address any regulatory queries promptly.

By following these steps and leveraging expert support, you can streamline your regulatory compliance and successfully launch your syringes in the Indian market.

For detailed guidance and personalized assistance, feel free to reach out to our regulatory experts who specialize in medical device licensing in India.