CDSCO License for Re use Prevention (RUP) syringes for therapeutic  injections (Syringes  with re-use prevention feature)

Comprehensive Guide to CDSCO Licensing for Reuse Prevention (RUP) Syringes – Class B Medical Device

Re-use prevention syringes designed for therapeutic injections are vital medical devices that ensure patient safety by preventing syringe reuse, thus reducing infection risks. Classified as Class B under the Indian medical device regulatory framework, these disposable hypodermic syringes require careful adherence to CDSCO licensing regulations for manufacturing and import. With over 25 years of industry expertise and having supported 500+ manufacturers in India, we provide an authoritative guide to help you navigate the CDSCO licensing process efficiently.

CDSCO Regulatory Framework for Reuse Prevention Syringes

The Central Drugs Standard Control Organisation (CDSCO) governs medical device regulation in India, enforcing the Medical Device Rules, 2017. Reuse prevention syringes fall under the category of disposable hypodermic syringes notified vide Notification 29/Misc/3/2017-DC (292) dated 06.06.2018. As Class B devices, they are considered moderate risk and require compliance with specific licensing, testing, and quality management system (QMS) standards before marketing.

Risk Classification and License Requirements for RUP Syringes

Reuse prevention syringes are classified as Class B devices due to their moderate risk profile. This classification mandates obtaining an MD5 manufacturing license under Form MD3 from the State Licensing Authority. For importers, an MD15 import license issued by the Central Licensing Authority is required. The classification and licensing requirements align with the Medical Device Rules and ensure patient safety and product efficacy.

Manufacturing License Process for Class B (MD5 License)

The MD5 license process involves several critical steps:

1. Obtain Test License (Form MD13): Initially, apply for a test license to allow product testing in notified labs; this takes approximately 1.5 to 2 months.

2. Product Testing: Conduct mandatory product testing at government-approved laboratories to validate compliance with Indian standards.

3. Document Preparation: Prepare comprehensive technical documentation including Device Master File (DMF), Plant Master File (PMF), and Risk Management File.

4. Application Submission: File the manufacturing license application on Form MD3 for MD5 via the CDSCO MD Online Portal.

5. Audit by Notified Body: Undergo an audit by a CDSCO-accredited notified body. You can check the list of notified bodies authorized to conduct audits.

6. Query Resolution: Respond to any queries or clarifications raised by the licensing authority or notified body.

7. License Grant: Upon satisfactory compliance, receive the MD5 manufacturing license on Form MD5.

For detailed procedural insights, our MD5 License Guide provides step-by-step assistance.

Manufacturing License Documents Required

Manufacturers must submit the following documents to support the MD5 application:

• Company constitution and incorporation certificate
• Proof of ownership or lease agreement of manufacturing premises
• Details and qualifications of technical staff
• Fire and pollution NOCs
• Device Master File (DMF): Detailed product specifications, manufacturing process, and validation (Learn more here)
• Plant Master File (PMF): Describes facility layout, equipment, and quality control systems (Refer this guide)
• Essential Principles Checklist demonstrating compliance with safety and performance
• Risk Management File adhering to ISO 14971 principles (See risk management best practices)
• Product test reports from CDSCO-approved testing laboratories (Find testing labs here)
• Labeling and Instructions for Use (IFU) compliant with regulatory standards
• Quality Management System (QMS) documents, typically ISO 13485:2016 certification

Import License Process for Class B Devices (MD15 License)

For importers bringing RUP syringes into India, the MD15 import license is mandatory. The process involves:

1. Document Compilation: Collect manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016, CE Certificate, DMF and PMF, wholesale license, and company constitution.

2. Application Submission: Submit the license application on Form MD14 via the CDSCO MD Online Portal.

3. Query Resolution: Address any department queries promptly.

4. License Issuance: After thorough review, the Central Licensing Authority grants the MD15 import license.

Unlike manufacturing licenses, no test license is required prior to import licensing. The complete process typically takes 5 to 6 months.

Our detailed Import License Guide can assist importers in navigating this process.

Import License Documents Required

Importers must provide:

• Valid foreign manufacturing license
• Free Sale Certificate from country of origin
• ISO 13485:2016 Quality Management System certificate
• CE Certificate or equivalent
• Device Master File and Plant Master File
• Valid wholesale license in India
• Company constitution and registration certificates

Timeline and Processing Duration

Manufacturers should anticipate a total of 3-4 months to obtain the MD5 license, which includes the test license, product testing, document preparation, audit, and query resolution. Importers should plan for a 5-6 month timeline.

Government Fees and Costs

These fees must be paid online during application submission through the CDSCO portal. Additional costs include product testing, audit fees charged by notified bodies, and consultancy fees if using external experts.

Common Challenges and Solutions

• Incomplete Documentation: Many applicants face delays due to missing or improperly formatted documents. Prepare DMF and PMF meticulously, using expert templates and checklists.

• Delayed Testing: Product testing in government labs can be time-consuming. Plan early and consider pre-testing in accredited private labs to preempt rejections.

• Audit Non-Compliance: Non-conformities found during notified body audits can stall approvals. Conduct internal audits and mock inspections to ensure compliance.

• Query Management: Timely and detailed responses to CDSCO queries are critical. Engage regulatory experts to draft precise replies.

• Regulatory Updates: Stay current with changing CDSCO guidelines to avoid obsolete submissions.

Expert Consultation and Support

With over 25 years of experience helping 500+ companies obtain CDSCO licenses, our team offers end-to-end regulatory consultancy—from document preparation to audit readiness and query resolution. We streamline the licensing journey for RUP syringe manufacturers and importers, ensuring compliance with minimal delays.

Getting Started with Your CDSCO License Application

1. Assess Device Classification: Confirm your RUP syringe as Class B via the Medical Device Classification guide.

2. Prepare Technical Files: Develop your Device Master File and Plant Master File following industry best practices.

3. Apply for Test License: Submit Form MD13 through the CDSCO MD Online Portal to initiate product testing.

4. Engage Accredited Labs: Schedule product testing at CDSCO-approved laboratories.

5. Compile Application: Gather all mandatory documents including QMS certificates, test reports, and essential principles checklist.

6. Schedule Audit: Coordinate with a notified body from the approved list for facility inspection.

7. Submit Manufacturing License Application: File Form MD3 for MD5 license on the CDSCO portal.

8. Respond to Queries: Maintain prompt communication with CDSCO and notified bodies to resolve any compliance questions.

Starting early and following these steps systematically greatly improves your chances of a smooth approval process. For personalized assistance, reach out to our consultancy team to expedite your journey to market.

Partner with seasoned experts who understand the nuances of CDSCO regulations for re-use prevention syringes. Contact us today to ensure your device’s compliance and successful entry into the dynamic Indian healthcare market.