CDSCO License for Intrauterine haemostatic suction catheter

Introduction to Intrauterine Haemostatic Suction Catheter and Regulatory Importance

The intrauterine haemostatic suction catheter is a vital obstetrical and gynecological medical device designed to reduce postpartum bleeding by aspirating blood and debris and inducing uterine contractions. Given its direct contact with internal body tissues and its critical function in managing postpartum hemorrhage, regulatory compliance in India is mandatory to ensure safety and efficacy.

With the CDSCO notification (File No. 29/Misc./03/2020-DC (181), dated 03.06.2022), this device is classified as Class B under the Indian medical device regulatory framework. This classification mandates obtaining a manufacturing license under Form MD5, which is regulated by the State Licensing Authority.

Understanding and navigating the CDSCO regulatory requirements is crucial for manufacturers and importers eager to enter or expand their presence in the Indian market. With over 25 years of regulatory consulting experience and support provided to 500+ companies, we provide you with precise guidance tailored to this device class.

CDSCO Regulatory Framework for Intrauterine Haemostatic Suction Catheter

The Central Drugs Standard Control Organisation (CDSCO) governs the regulation of medical devices in India. The framework is risk-based, and devices like the intrauterine haemostatic suction catheter fall under Class B, which demands adherence to specified quality, safety, and performance standards.

As per the recent notification dated June 3, 2022, these devices require a manufacturing license under Form MD5 issued by the State Licensing Authority. The process includes product testing, audits, and fulfillment of quality system requirements in line with Indian medical device rules.

Risk Classification and License Requirements

The intrauterine haemostatic suction catheter is a Class B medical device. Class B devices are considered low to moderate risk and require the following:

Manufacturing License: MD5 license (Form MD3 application) obtained from the State Licensing Authority.
Test License: A prerequisite test license on Form MD13 to carry out product testing.
Product Testing: To be conducted in government-approved testing laboratories.
Audit: A mandatory audit by a notified body listed by CDSCO.

For more details on risk classification and to verify your device class, refer to our Medical Device Classification guide.

Manufacturing License Process (MD5) for Class B Devices

Step 1: Obtain Test License (Form MD13)

Begin by applying for the test license on Form MD13 via the CDSCO MD Online Portal. This license permits the testing of your intrauterine catheter samples in approved laboratories. The test license typically takes 1.5 to 2 months for processing.

Step 2: Product Testing

Submit your samples to CDSCO-approved laboratories for mandatory product testing. You can find the list of government-approved testing laboratories here. Testing usually takes 1 to 1.5 months depending on the workload and complexity.

Step 3: Documentation Preparation

Prepare comprehensive documentation including the Device Master File (DMF), Plant Master File (PMF), Essential Principles Checklist, Risk Management File, Quality Management System (QMS) records, and test reports. Our detailed Device Master File guide and Plant Master File guide can assist you in compiling these documents.

Step 4: Application Submission (Form MD3)

Submit your application for the manufacturing license under Form MD3 through the CDSCO MD Online Portal. Ensure all documents are complete and compliant to avoid delays.

Step 5: Audit by Notified Body

The State Licensing Authority will assign an audit by a notified body from the official Notified Bodies List. The audit includes evaluation of manufacturing facilities, QMS implementation, and compliance with regulatory standards.

Step 6: Query Resolution

Post-audit, the licensing authority may raise queries. Prompt and comprehensive responses are essential to avoid prolonging the process.

Step 7: License Grant (Form MD5)

Upon successful completion of all steps, the manufacturing license in Form MD5 will be granted, authorizing you to manufacture the intrauterine haemostatic suction catheter in India.

Manufacturing License Documents Required

For the Class B intrauterine haemostatic suction catheter, your application must include:

Company Constitution (Incorporation Certificate, Memorandum & Articles of Association)
Proof of ownership or lease of manufacturing premises
Details of technical staff qualifications and experience
Fire and Pollution No Objection Certificates (NOCs)
Device Master File (DMF)
Plant Master File (PMF)
Essential Principles Checklist ensuring compliance with safety and performance standards
Risk Management File specific to the device
Product Test Reports from CDSCO-approved laboratories
Labeling and Instructions for Use (IFU) documents
Quality Management System documents (ISO 13485:2016 certification recommended)

Import License Process (MD15) for Intrauterine Haemostatic Suction Catheter

For importers aiming to bring this Class B device into India, an import license under Form MD15 issued by the Central Licensing Authority is mandatory.

Key Steps:

Prepare required documents such as Manufacturing License from the country of origin, Free Sale Certificate, ISO 13485:2016, CE Certificate, Device and Plant Master Files, and wholesale license.
Submit application on the CDSCO MD Online Portal.
Respond promptly to departmental queries.

The import license process typically takes 5 to 6 months. For detailed guidance, refer to our Import License guide.

Timeline and Processing Duration

Process Step	Estimated Duration
Test License (MD13)	1.5 – 2 months
Product Testing	1 – 1.5 months
Document Preparation	2 – 3 weeks (parallel)
Application Processing	1 month
Audit by Notified Body	2 – 3 weeks
Query Resolution	2 – 4 weeks
Total Time for MD5 License	3 to 4 months approx.

Being proactive in document readiness and query resolution can shorten this timeline significantly.

Government Fees and Costs

The fee structure for the MD5 manufacturing license for Class B devices is as follows:

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

Additional costs may include:

Testing laboratory charges (varies by lab and tests, typically Rs. 50,000 – 1,00,000)
Audit fees charged by notified bodies
Costs related to document preparation and consultancy services

Budget accordingly to avoid surprises during the licensing process.

Common Challenges and Solutions

Challenge 1: Delays due to incomplete documentation

Solution: Use comprehensive checklists and expert review before submission. Refer to our Device Master File guide and Plant Master File guide for compliance.

Challenge 2: Product testing failures or delays

Solution: Select reputable, government-approved labs from the Testing Laboratories list, and conduct internal pre-testing to identify issues early.

Challenge 3: Audit non-compliance findings

Solution: Implement a robust QMS and conduct internal mock audits. Engaging notified bodies early for pre-audit consultations can be invaluable.

Challenge 4: Slow query resolution

Solution: Assign dedicated regulatory personnel to monitor and respond promptly to CDSCO communications.

Expert Consultation and Support

Navigating the CDSCO licensing maze can be complex, especially for specialized devices like the intrauterine haemostatic suction catheter. With over 25 years of experience assisting 500+ manufacturers and importers, we offer:

End-to-end license application management
Documentation preparation and review
Pre-audit readiness assessments
Regulatory intelligence updates
Liaison with CDSCO and State Authorities

Our tailored support reduces approval time and enhances compliance, ensuring a smooth market entry.

Getting Started with Your CDSCO License Application

Assess Your Device Classification: Confirm your Class B status using the Medical Device Classification guide.
Prepare Key Documentation: Begin compiling your Device Master File, Plant Master File, and Risk Management File.
Apply for Test License (MD13): Submit your test license application through the CDSCO MD Online Portal.
Select Testing Laboratory: Choose a CDSCO-approved lab from the official list.
Plan for Audit: Identify a notified body for the required audit via the Notified Bodies List.
Consult Experts: Engage experienced regulatory consultants to review your application package and audit preparedness.

By following these actionable steps early, you position your intrauterine haemostatic suction catheter for timely approval under the MD5 licensing pathway, ensuring compliance and swift market access in India.