CDSCO License for Handling medium

Comprehensive Guide to CDSCO Licensing for Handling Medium (Class C Medical Device)

In the expanding field of assisted reproductive technology (ART), the Handling Medium plays a critical role. This specialized medical device is intended for use in procedures involving the manipulation of gametes and embryos—specifically as an oocyte retrieval medium during ovarian follicle aspiration, washing sperm before IVF and ICSI, and transporting embryos during embryo transfer. With components such as Gentamicin and Human Serum Albumin (HSA), it falls under the Obstetrical and Gynecological category and is classified as a Class C medical device by the CDSCO.

Given the complexity and sensitive nature of its use, regulatory compliance is paramount for market entry in India. With over 25 years of experience helping 500+ companies navigate CDSCO licensing, we provide a detailed, actionable roadmap tailored for this device type.

CDSCO Regulatory Framework for Handling Medium

The Central Drugs Standard Control Organization (CDSCO) regulates all medical devices in India. Handling Medium being a Class C device requires licensing from the Central Licensing Authority. The device must comply with the Medical Device Rules, 2017, and meet safety, quality, and performance standards as per the notified guidelines.

The official notification for this device is referenced under File No. 29/Misc./03/2020-DC (181) dated 03.06.2022, confirming its classification and regulatory pathway.

To begin, manufacturers or importers must understand the specific risk classification and licensing requirements before initiating the application process.

Risk Classification and License Requirements for Handling Medium

The Handling Medium is a Class C medical device, which implies moderate to high risk. According to CDSCO guidelines:

• Class C Devices require an MD9 manufacturing license granted by the Central Licensing Authority.
• Importers must obtain an MD15 import license also from the central authority.

The classification impacts the documentation, testing, audit, and timelines involved in licensing.

For detailed classification info, see our Medical Device Classification guide.

Manufacturing License Process for Class C Devices (MD9 License)

For manufacturers, the licensing process is comprehensive, given the higher risk class:

1. Test License Application (Form MD13): This preliminary license allows product testing and takes approximately 1.5 to 2 months.
2. Product Testing: Testing must be conducted at government-approved laboratories to validate safety and performance. Refer to the list of testing laboratories.
3. Document Preparation: Prepare the technical dossier, including Device Master File and Plant Master File.
4. License Application (Form MD7): Submit the manufacturing license application via the CDSCO MD Online Portal after test license and product testing.
5. Audit by CDSCO Inspectors: The central authority will conduct an onsite audit reviewing quality systems and compliance.
6. Query Resolution: Address any observations or queries raised during the audit.
7. Grant of MD9 License: Upon successful completion, the license is granted on Form MD9.

The entire process typically takes 4 to 5 months.

For a step-by-step walkthrough, refer to our comprehensive MD9 License Guide.

Manufacturing License Documents Required for Handling Medium

Meticulous documentation is critical. For Class C devices like Handling Medium, you will need:

• Company Constitution Documents (e.g., incorporation certificate)
• Proof of Ownership or Lease of Manufacturing Premises
• Technical Staff Qualifications and Experience
• Fire NOC and Pollution Control NOC
• Device Master File (DMF) detailing design, components, and specifications. See our Device Master File guide.
• Plant Master File (PMF) describing manufacturing facilities and processes. Our Plant Master File guide can assist.
• Essential Principles Compliance Checklist
• Risk Management File documenting hazard analysis and mitigation (see Risk Management).
• Test Reports from Government-Approved Laboratories
• Product Labels and Instructions for Use (IFU) compliant with CDSCO norms
• Quality Management System Documents (typically ISO 13485:2016 certified)

Preparing these documents thoroughly reduces audit queries and expedites licensing.

Import License Process for Handling Medium (MD15 License)

Importers of Handling Medium must secure an MD15 import license, which involves:

1. Document Preparation: Including manufacturing license, Free Sale Certificate from the country of origin, ISO 13485:2016 certification, CE Certificate if applicable, and device-specific files.
2. Application Submission (Form MD14): Submit via the CDSCO MD Online Portal.
3. Query Resolution: Address clarifications from CDSCO.
4. Grant of MD15 License: Final approval typically takes 5 to 6 months.

Note that no test license is required for import applications.

For detailed guidance, consult our Import License Guide.

Import License Documents Required

Essential documents for MD15 include:

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

Having these ready and verified avoids common pitfalls and delays.

Timeline and Processing Duration

Planning accordingly helps in aligning product launch timelines.

Government Fees and Costs

For the Handling Medium (Class C device), approximate fees are:

• MD9 Manufacturing License:

  • Application fee: ₹50,000
  • Per product fee: ₹1,000

• MD15 Import License:

  • Site fee: $3,000
  • Per product fee: $1,500

Additional costs include testing fees at government labs and expenses related to audits and document preparation.

Common Challenges and Solutions

Challenge: Delays in test license approval and product testing.

Solution: Submit a complete and well-prepared test license application, engage with notified testing labs early, and monitor test progress closely.

Challenge: Incomplete or inconsistent documentation causing audit observations.

Solution: Use expert guidance for preparing Device Master Files and Plant Master Files; ensure QMS compliance; cross-check all documents before submission.

Challenge: Responding to CDSCO queries can be time-consuming.

Solution: Maintain clear communication lines with CDSCO officials, prepare detailed, evidence-backed responses, and address queries promptly.

Expert Consultation and Support

With over 25 years of experience and having assisted more than 500 companies, we offer end-to-end regulatory support—from initial classification to audit readiness and license grant.

Our services include:

• Gap analysis of existing documentation
• Preparation and review of Device Master File and Plant Master File
• Liaison with notified bodies and CDSCO inspectors
• Assistance with product testing coordination
• Timely resolution of regulatory queries

Partnering with experts significantly improves approval chances and shortens timelines.

Getting Started with Your CDSCO License Application for Handling Medium

1. Assess your device classification carefully to confirm Class C status.
2. Compile preliminary documents such as company constitution, premises proof, and staff qualifications.
3. Initiate test license application (Form MD13) through the CDSCO MD Online Portal.
4. Engage with government-approved testing laboratories early to schedule product testing.
5. Prepare detailed technical documentation including DMF, PMF, and Risk Management File.
6. Plan for audit readiness by reviewing quality systems and compliance controls.
7. Consider expert regulatory consultancy to navigate complex requirements efficiently.

Embarking on the CDSCO licensing journey well-prepared allows you to bring this vital Handling Medium device to the Indian market safely and compliantly, facilitating improved assisted reproductive outcomes.

For personalized assistance and a smooth application process, contact our experienced regulatory consultants today.