CDSCO License for Intrauterine cannula, reusable
Medical Device Information
Intended Use
To aspirate fluid/material from the uterus for treatment of incomplete abortion, first trimester abortion, and/or for menstrual regulation; it may also be intended for endometrial biopsy.
Regulatory Overview of Intrauterine Cannula (Reusable) in India
The reusable intrauterine cannula is a critical obstetrical and gynecological medical device used primarily to aspirate fluid or material from the uterus. It plays a vital role in treating incomplete abortion, first trimester abortion, menstrual regulation, and is also used for endometrial biopsy procedures. Given its direct interaction with sensitive uterine tissue, regulatory oversight is stringent to ensure patient safety and device efficacy.
In India, this device is classified under Class B (Low Moderate Risk) according to the CDSCO classification system. The device is officially notified under File No. 29/Misc./03/2020-DC (181), dated 03.06.2022, emphasizing its recognition and regulatory monitoring by the Central Drugs Standard Control Organization (CDSCO).
CDSCO Regulatory Framework for Reusable Intrauterine Cannula
CDSCO governs the import and manufacture of medical devices in India under the Medical Device Rules, 2017. For the intrauterine cannula, being a Class B device, the regulatory pathway involves obtaining an MD5 manufacturing license if you plan to manufacture within India, or an MD15 import license if you intend to import the device.
All applications and communications are processed through the CDSCO MD Online Portal, which streamlines submissions, queries, and approvals.
Risk Classification and License Requirements
- Device Risk Class: B (Low Moderate Risk)
- License Type for Manufacturing: MD5 (State Licensing Authority)
- Application Form: MD3 for MD5 license
- License Type for Import: MD15 (Central Licensing Authority)
- Application Form: MD14 for import license
Class B devices like reusable intrauterine cannula require compliance with essential principles and mandatory quality standards to ensure safety and performance.
Manufacturing License Process for MD5 License
Our experience with over 500 companies shows the MD5 license process typically spans 3 to 4 months. The process includes:
- Test License Application (Form MD13): Mandatory before full manufacturing license; takes about 1.5 to 2 months.
- Product Testing: Conducted at government-approved labs listed on the Testing Laboratories page. Testing confirms compliance with safety and performance standards.
- Documentation Preparation: Comprehensive technical documentation, including Device Master File (DMF) and Plant Master File (PMF).
- Manufacturing License Application (Form MD3): Submitted on the CDSCO portal.
- Audit by Notified Body: An audit is conducted by a notified body from the official list of notified bodies to verify compliance.
- Query Resolution: Address any clarifications or additional information requests.
- Grant of MD5 License: Issued upon successful audit and document verification.
Licensing Fees
- Application Fee: INR 5,000
- Per Product Fee: INR 500
Manufacturing License Documents Required
For the reusable intrauterine cannula, you will need the following:
- Company constitution and registration documents
- Proof of ownership or lease of manufacturing premises
- Qualified technical staff details and their qualifications
- Fire and pollution NOCs
- Device Master File (DMF): Detailed design, materials, and specifications (Learn more about DMF)
- Plant Master File (PMF): Manufacturing processes, equipment, and quality control (PMF guide)
- Essential Principles Checklist confirming compliance with Indian Medical Device Rules
- Risk Management File documenting hazard analysis and mitigation (Risk Management guidance)
- Test reports from CDSCO-approved labs
- Product labels and Instructions for Use (IFU)
- Quality Management System (QMS) documents, preferably ISO 13485:2016 compliant
Import License Process (MD15 License)
If you plan to import the reusable intrauterine cannula, the MD15 license process is handled by the Central Licensing Authority and generally takes 5 to 6 months due to comprehensive document review.
Steps include:
- Document Preparation: Including manufacturing license of the foreign manufacturer, Free Sale Certificate, ISO 13485:2016 certification, CE marking (if applicable), and technical files.
- Application Submission: On the CDSCO MD Online Portal using Form MD14.
- Query Resolution: Timely response to any CDSCO queries.
- Grant of MD15 License: Upon successful document verification.
Import License Fees (approximate):
- Site Fee for Class B Device: USD 2,000
- Per Product Fee: USD 1,000
Import License Documents Required
Key documents for the MD15 import license include:
- Manufacturer’s valid manufacturing license
- Free Sale Certificate from the country of origin
- ISO 13485:2016 Quality Management Certificate
- CE Certification or equivalent
- Device Master File and Plant Master File
- Wholesale Drug License for import
- Company constitution and registration proofs
Timeline and Processing Duration Summary
| License Type | Timeline | Key Milestones |
|---|---|---|
| MD5 Manufacturing | 3-4 months | Test license (1.5-2 months), Testing, Audit |
| MD9 Manufacturing | 4-5 months | (For Class C/D devices, not applicable here) |
| MD15 Import | 5-6 months | Document verification, Query resolution |
Government Fees and Costs Breakdown
| License Type | Application Fee | Per Product Fee | Total (for 1 product) |
|---|---|---|---|
| MD5 | INR 5,000 | INR 500 | INR 5,500 |
| MD15 | USD 2,000 | USD 1,000 | USD 3,000 |
Please note: Additional costs may include notified body audit fees, product testing charges at government labs, and consultancy fees if you engage expert support.
Common Challenges and Solutions
- Delayed Testing Approvals: Testing laboratories may have backlogs; early booking is crucial.
- Incomplete Documentation: Missing or inconsistent DMF or PMF details often cause delays; use our Device Master File guide to prepare accurate files.
- Audit Non-Conformities: Pre-audit internal checks and hiring experienced notified bodies reduce risks.
- Query Responses: Prompt and comprehensive replies to CDSCO queries can shorten processing times.
Expert Consultation and Support
Having assisted over 500 companies in achieving CDSCO approvals, we understand the nuances of intrauterine cannula licensing. Our expertise spans document preparation, audit coordination, and regulatory submissions, ensuring a smooth pathway to market entry.
Engage with us early to benefit from:
- End-to-end license application handling
- Gap analysis to identify and rectify documentation lapses
- Liaison with notified bodies and testing labs
- Strategic guidance on risk management and compliance
Getting Started with Your CDSCO License Application
- Assess Your Device Classification: Confirm the Class B status through the Medical Device Classification guide.
- Prepare Essential Documentation: Start compiling your DMF, PMF, risk management, and QMS documents.
- Apply for Test License (for manufacturing): Submit Form MD13 via the CDSCO MD Online Portal.
- Schedule Product Testing: Book slots at CDSCO-approved testing labs early.
- Identify a Notified Body: Select from the official Notified Bodies list for the mandatory audit.
- Submit Manufacturing License Application: After successful testing, apply using Form MD3 for MD5 license.
- Prepare for Audit: Conduct internal mock audits and ensure compliance readiness.
- Respond to Queries Promptly: Keep your regulatory team on standby for quick clarifications.
For importers, initiate document collection and submit the MD15 application directly through the CDSCO portal.
By following this detailed roadmap and leveraging our 25+ years of regulatory experience, you can confidently navigate the CDSCO approval process for your reusable intrauterine cannula and successfully launch in the Indian market.
