CDSCO License for Oocyte Aspiration Needle

Comprehensive Guide to CDSCO Licensing for Oocyte Aspiration Needle (Class B Medical Device)

The Oocyte Aspiration Needle is a specialized disposable hypodermic needle designed to efficiently collect the maximum number of undamaged oocytes in the shortest possible time. As a Class B medical device under CDSCO regulations, it is subject to specific compliance requirements to ensure safety, quality, and efficacy in the Indian market. Navigating the regulatory landscape can be complex, but with over 25 years of experience assisting 500+ companies, we provide you with detailed, actionable guidance to secure your CDSCO license smoothly.

CDSCO Regulatory Framework for Oocyte Aspiration Needle

The Central Drugs Standard Control Organization (CDSCO) governs the import, manufacture, and sale of medical devices in India. The Oocyte Aspiration Needle is notified under the category of disposable hypodermic needles, falling under Risk Class B according to the notification 29/Misc/3/2017-DC (292), dated 06.06.2018.

This classification mandates compliance with specific quality standards, technical documentation, and regulatory protocols before market entry. The licensing authority for Class B devices is the State Licensing Authority, and the relevant manufacturing license is the MD5 License.

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

Risk Classification and License Requirements for Oocyte Aspiration Needle

As a Class B device, the Oocyte Aspiration Needle requires an MD5 manufacturing license granted by the State Licensing Authority. Key points include:

• Risk Class: B (Low Moderate Risk)
• License Type: MD5 (Form MD3 application)
• Authority: State Drug Control Department
• Process Duration: Approximately 3-4 months
• Test License: Mandatory test license on Form MD13 before MD5 application

This two-step licensing process ensures thorough testing and audit compliance before the final manufacturing license is granted.

Manufacturing License Process (MD5) for Oocyte Aspiration Needle

The MD5 license process involves several sequential steps:

1. Test License Application (Form MD13): Obtain a test license to manufacture the device for testing purposes. This stage typically takes 1.5 to 2 months.

2. Product Testing: Conduct mandatory product testing at government-approved laboratories. Testing parameters cover biocompatibility, sterility, and mechanical integrity. See the list of CDSCO-approved testing laboratories.

3. Document Preparation: Compile device master file, plant master file, quality management system documents, and other technical files.

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

5. Audit by Notified Body: A notified body conducts a site audit to verify compliance. Refer to the list of notified bodies for audit arrangements.

6. Resolution of Queries: Address any observations or clarifications requested by the licensing authority or notified body.

7. Grant of MD5 License: Upon satisfactory review and audit, the State Licensing Authority issues the manufacturing license in Form MD5.

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

Manufacturing License Documents Required for Oocyte Aspiration Needle

The documentation dossier is critical to demonstrate compliance and quality. For the Oocyte Aspiration Needle, the following documents are mandatory:

• Company Constitution Documents: Incorporation certificate, partnership deed, or proprietorship proof
• Proof of Ownership or Lease of Manufacturing Premises
• Details of Technical Staff: CVs, qualifications, and experience
• Fire NOC and Pollution Control NOC
• Device Master File (DMF): Detailed technical specifications, design, manufacturing processes, and testing protocols. Our Device Master File guide provides comprehensive assistance.
• Plant Master File (PMF): Description of manufacturing facilities and quality control systems. Create your PMF easily using our Plant Master File Guide.
• Essential Principles Checklist: Compliance with Indian medical device regulations
• Risk Management File: Risk analysis and mitigation strategies aligned with ISO 14971 standards. Learn more on implementing risk management.
• Test Reports: From government-approved labs validating safety and performance
• Labels and Instructions for Use (IFU): Regulatory-compliant labeling and user guidance
• Quality Management System Documents: Typically ISO 13485:2016 certification and internal SOPs

Accurate and thorough documentation reduces review times and audit observations.

Import License Process (MD15) for Oocyte Aspiration Needle

If you intend to import the Oocyte Aspiration Needle into India, the applicable license is the MD15 Import License, issued by the Central Licensing Authority.

Key highlights:

• No test license required beforehand
• Application on Form MD14 via CDSCO MD Online Portal
• Documents Required: Manufacturing license from country of origin, Free Sale Certificate, ISO 13485:2016, CE Certificate, Device Master File, Plant Master File, wholesale license (if applicable), and company constitution
• Application Processing Time: Around 5-6 months
• Government Fees: Based on risk class and number of products

For detailed steps, check our Import License Guide.

Timeline and Processing Duration

Planning for possible delays due to audit scheduling or queries is prudent. Early preparation of documentation can significantly shorten timelines.

Government Fees and Costs for MD5 License

The fee structure for manufacturing Oocyte Aspiration Needle (Class B) is as follows:

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

Additional costs include:

• Testing charges at government-approved labs (variable, generally INR 50,000 to 1,00,000 depending on tests)
• Audit fees payable to notified bodies
• Internal costs for document preparation and quality system implementation

Budgeting for these costs upfront helps avoid surprises and ensures smooth process flow.

Common Challenges and Practical Solutions

Challenge 1: Delays in Product Testing

• Solution: Engage early with approved labs; understand test requirements upfront to avoid retesting.

Challenge 2: Non-compliance Observations During Audit

• Solution: Conduct pre-audit internal assessments and gap analysis. Utilize notified body checklists.

Challenge 3: Incomplete Documentation

• Solution: Use standardized templates and consult experienced regulatory experts to prepare comprehensive dossiers.

Challenge 4: Query Resolution Delays

• Solution: Assign a dedicated regulatory liaison to promptly address queries with detailed evidence.

Expert Consultation and Support

With over 25 years in medical device regulatory consultancy and having supported more than 500 manufacturers and importers, we provide end-to-end assistance for your Oocyte Aspiration Needle licensing journey. From device master file preparation to audit readiness and query management, our experts ensure compliance and timely approvals.

Our services include:

• Regulatory strategy and classification advice
• Documentation and dossier preparation
• Coordination with notified bodies and testing laboratories
• Training on quality management systems
• Post-approval compliance support

Getting Started with Your CDSCO License Application

To initiate your CDSCO licensing process for the Oocyte Aspiration Needle:

1. Register on the CDSCO MD Online Portal
2. Apply for the Test License (Form MD13) with complete documents
3. Schedule product testing at government-approved laboratories
4. Prepare your Device Master File and Plant Master File using expert guides
5. Once test license is granted and testing completed, apply for MD5 manufacturing license (Form MD3)
6. Coordinate audit scheduling with a notified body
7. Maintain transparent communication with the licensing authority to resolve any queries swiftly

By following these steps and leveraging expert guidance, you can successfully bring your Oocyte Aspiration Needle to the Indian market with full regulatory compliance.

For personalized assistance and comprehensive support, connect with our regulatory consultants today and ensure a smooth licensing experience.