CDSCO License for Aspiration Syringe

Comprehensive CDSCO Licensing Guide for Aspiration Syringe (Class B Medical Device)

Aspiration syringes, primarily used for laparoscopic aspiration or injection, fall under the category of disposable hypodermic syringes and are classified as Class B medical devices by the Central Drugs Standard Control Organization (CDSCO) in India. With the notification number 29/Misc/3/2017-DC (292) dated 06.06.2018, regulatory compliance for these devices has become essential to ensure safety, efficacy, and market access.

Having supported over 500 manufacturers and importers in navigating the CDSCO licensing landscape, we provide a detailed, step-by-step guide tailored specifically for Aspiration Syringe manufacturers and importers to help you achieve seamless compliance.

CDSCO Regulatory Framework for Aspiration Syringe

Aspiration syringes are regulated under the Medical Device Rules, 2017, falling under Class B risk due to their moderate risk profile. Compliance with CDSCO ensures that these devices meet Indian regulatory standards concerning safety, quality, and performance. The CDSCO framework mandates licensing based on risk classification, with Class A and B devices requiring an MD5 Manufacturing License granted by State Licensing Authorities.

Risk Classification and License Requirements for Aspiration Syringe

Being a Class B device, the Aspiration Syringe requires an MD5 license for manufacturing within India. Manufacturers must obtain the test license (Form MD13) first, followed by product testing at government-approved labs, and finally the MD5 license application (Form MD3).

Importers of Aspiration Syringe must secure the MD15 Import License from the Central Licensing Authority.

For detailed classification, consult our Medical Device Classification resource.

Manufacturing License Process for Aspiration Syringe (MD5 License)

The MD5 license process involves multiple stages:

1. Test License Application (Form MD13): Apply through the CDSCO MD Online Portal to obtain a test license, which takes approximately 1.5 to 2 months.

2. Product Testing: Test your aspiration syringes at government-approved labs listed on the CDSCO Testing Laboratories portal.

3. Documentation Preparation: Compile comprehensive documents including Device Master File and Plant Master File.

4. MD5 License Application (Form MD3): Submit the manufacturing license application via the CDSCO portal.

5. Audit by Notified Body: Engage a notified body for audit; you can find the list of notified bodies here.

6. Queries and Clarifications: Respond promptly to any queries raised by the CDSCO or the notified body.

7. License Grant: Upon successful review, the MD5 license is granted.

Manufacturing License Documents Required for Aspiration Syringe

To streamline your application, ensure the following documents are prepared accurately:

• Company Constitution Documents: Incorporation certificate, Memorandum of Association, Articles of Association
• Proof of Premises Ownership: Rent agreement or property deed
• Technical Personnel Documents: Qualification and experience proofs of technical staff
• No Objection Certificates: Fire NOC and Pollution Control Board NOC
• Device Master File (DMF): Detailed device specifications, design, and manufacturing process (Device Master File Guide)
• Plant Master File (PMF): Manufacturing facility details and quality management system (Plant Master File Guide)
• Essential Principles Checklist: Compliance with Indian regulatory essential principles
• Risk Management File: Risk analysis and mitigation strategies (Risk Management)
• Test Reports: Results from government-approved labs
• Labels and Instructions for Use (IFU): Drafts for labeling and user manuals
• Quality Management System Documents: ISO 13485 certification and internal SOPs

Import License Process for Aspiration Syringe (MD15 License)

Importers must apply for the MD15 license from the Central Licensing Authority, following these steps:

1. Documentation Preparation: Collect necessary documents including Manufacturing License from the country of origin, Free Sale Certificate, ISO 13485:2016, CE Certificate, Device Master File, and Plant Master File.

2. Application Submission: Submit Form MD14 through the CDSCO MD Online Portal.

3. Query Resolution: Address any queries raised by CDSCO promptly.

4. License Issuance: After successful evaluation, the MD15 import license is granted, typically within 5-6 months.

Import License Documents Required

• Valid Manufacturing License from the country of origin
• Free Sale Certificate
• ISO 13485:2016 Certification
• CE Certificate (if applicable)
• Device Master File
• Plant Master File
• Wholesale Drug License
• Company Constitution Documents

Timeline and Processing Duration

Typically, the entire manufacturing license process from test license application to MD5 license grant takes approximately 3 to 4 months. Import licensing extends to about 5 to 6 months due to additional document verification.

Government Fees and Costs

For Aspiration Syringe (Class B device), the fee structure is as follows:

• MD5 Manufacturing License: Rs. 5,000 per application + Rs. 500 per product
• MD13 Test License: Included in the manufacturing process fees
• MD15 Import License: USD 2,000 per site + USD 1,000 per product

Budgeting accurately for these fees upfront can prevent delays.

Common Challenges and Solutions

Challenge 1: Delay in Product Testing

Solution: Pre-select government-approved labs early and schedule testing promptly. Use the Testing Laboratories list to find suitable facilities.

Challenge 2: Incomplete Documentation

Solution: Follow our detailed checklists for Device Master File and Plant Master File preparation. Consult guides like the Device Master File Guide and Plant Master File Guide.

Challenge 3: Audit Non-compliance

Solution: Conduct internal pre-audit assessments and ensure your QMS aligns with ISO 13485. Choose notified bodies from the official list of notified bodies for MD5 audit.

Challenge 4: Query Resolution Delays

Solution: Assign dedicated regulatory personnel to monitor application status and respond promptly to CDSCO queries.

Expert Consultation and Support

With over 25 years of experience, our dedicated regulatory consultants have successfully guided 500+ companies through the CDSCO licensing maze for devices like Aspiration Syringes. We offer tailored support including:

• Documentation preparation and review
• Liaison with notified bodies and testing labs
• Audit readiness and training
• Application submission and follow-up

Our proactive approach reduces approval times and ensures compliance.

Getting Started with Your CDSCO License Application

1. Assess Your Device Classification: Confirm the Class B status of your Aspiration Syringe.

2. Prepare Technical Documentation: Initiate Device Master File and Plant Master File development early.

3. Apply for Test License (MD13): Submit through the CDSCO MD Online Portal.

4. Schedule Product Testing: Contact government-approved labs to arrange testing.

5. Compile Complete Application: Gather all required documents and apply for MD5 license (Form MD3).

6. Arrange Audit: Coordinate with a notified body from the official list to complete the audit.

7. Stay Responsive: Monitor application status regularly and respond to any queries promptly.

By following these actionable steps, you can expedite your entry into the Indian medical device market with your Aspiration Syringe.

For personalized assistance or to discuss your specific regulatory challenges, contact our expert team today and leverage our 25+ years of industry experience for a successful CDSCO licensing journey.