CDSCO License for Fixed-diameter cervical dilator, reusable
Medical Device Information
Intended Use
To dilate the cervical canal with balloon when uterine does not dilate enough due to inertia uteri.
Comprehensive Guide to CDSCO Licensing for Fixed-Diameter Cervical Dilator (Reusable) – Class B Medical Device
As seasoned regulatory consultants with over 25 years of experience and a track record of assisting 500+ companies in successfully navigating CDSCO licensing, we provide authoritative guidance for manufacturers and importers of Fixed-diameter cervical dilators (reusable) targeting the Indian market. This obstetrical and gynecological device, intended to dilate the cervical canal when uterine inertia limits natural dilation, is classified as a Class B medical device under CDSCO regulations.
CDSCO Regulatory Framework for Fixed-Diameter Cervical Dilator
The Central Drugs Standard Control Organization (CDSCO) governs medical device approvals in India under the Medical Devices Rules, 2017. Your Fixed-diameter cervical dilator falls under the Obstetrical and Gynecological category with Notification File No. 29/Misc./03/2020-DC (181), dated 03.6.2022, confirming its inclusion in the notified devices list.
Compliance with CDSCO regulations ensures your device meets safety, efficacy, and quality benchmarks essential for market access and patient safety.
Risk Classification and License Requirements
Your device’s classification as Class B (low-moderate risk) mandates obtaining an MD5 Manufacturing License from the State Licensing Authority. This license is specific to Class A and B devices and requires adherence to a defined regulatory pathway including testing, audits, and documentation.
Refer to the Medical Device Classification guide for detailed classification insights.
Manufacturing License Process (MD5) for Class B Devices
The MD5 license process is a multi-step procedure taking approximately 3 to 4 months from start to finish. Here’s the detailed roadmap:
Test License Application (Form MD13): Apply for a test license enabling clinical and laboratory testing of your device. This step takes about 1.5 to 2 months.
Product Testing: Conduct mandatory product testing in CDSCO-approved labs. For your device, tests will focus on biocompatibility, mechanical integrity, sterility validation (if applicable), and performance efficacy.
Documentation Preparation: Compile comprehensive technical documentation including Device Master File, Plant Master File, Essential Principles Checklist, Risk Management File, and Quality Management System (QMS) evidence.
License Application (Form MD3): Submit the manufacturing license application via the CDSCO MD Online Portal.
Audit by Notified Body: A notified body listed on the CDSCO Notified Bodies List will conduct a thorough audit of your manufacturing facility and quality processes.
Query Resolution: Address any queries or observations raised by CDSCO or the notified body promptly to avoid delays.
Grant of MD5 License (Form MD5): Upon successful audit and query clearance, the license is issued.
Manufacturing License Documents Required
For your Fixed-diameter cervical dilator, the following documents are essential:
- Company Constitution: Certificate of Incorporation, Memorandum & Articles of Association
- Proof of Premises Ownership/Lease: Valid ownership documents or lease agreements
- Technical Staff Details: Qualification and experience of manufacturing and quality personnel
- Fire Safety NOC: Fire department clearance certificate
- Pollution Control NOC: Certificate from State Pollution Control Board
- Device Master File (DMF): Detailed device description, specifications, manufacturing process, and design validation (Device Master File guide)
- Plant Master File (PMF): Details about the manufacturing facility, equipment, infrastructure (Plant Master File guide)
- Essential Principles Checklist: Compliance checklist confirming adherence to Indian Essential Principles
- Risk Management File: Risk analysis and mitigation strategies per ISO 14971 (Risk Management guide)
- Test Reports: Laboratory test certificates from CDSCO-approved testing labs (Testing Laboratories list)
- Labels & Instructions for Use (IFU): Device labeling and user manuals
- Quality Management System (QMS) Documents: ISO 13485 certificates and internal SOPs
Import License Process (MD15)
If you plan to import this device into India, the process differs slightly. An MD15 import license is required from the Central Licensing Authority. The process takes approximately 5 to 6 months and involves:
- Document preparation (including existing manufacturing license from the country of origin)
- Application submission via the CDSCO MD Online portal
- Responding to queries from the CDSCO
- License grant
For a detailed overview, see our Import License guide.
Import License Documents Required
- Manufacturing License from country of origin
- Free Sale Certificate
- ISO 13485:2016 Certificate
- CE Certificate (if applicable)
- Device Master File
- Plant Master File
- Wholesale license in India
- Company Constitution
Timeline and Processing Duration
| Step | Duration |
|---|---|
| Test License (MD13) | 1.5 – 2 months |
| Product Testing | 3 – 4 weeks |
| Document Preparation | 3 – 4 weeks |
| Manufacturing License (MD5) | 1 – 1.5 months |
| Total Time | Approximately 3-4 months |
Government Fees and Costs
- MD5 Application Fee: ₹5,000 per application
- Per Product Fee: ₹500
Additional costs may include:
- Testing fees charged by government-approved labs
- Notified body audit fees
- Consultant fees if you engage expert help
Common Challenges and Solutions
Challenge: Delays due to incomplete documentation or non-compliance with Essential Principles
Solution: Early and thorough preparation of Device and Plant Master Files and pre-audit internal checks ensure smoother approval.
Challenge: Extended timelines caused by delayed product testing
Solution: Engage with CDSCO-approved testing labs in advance and schedule testing promptly after obtaining the test license.
Challenge: Audit non-conformities
Solution: Conduct mock audits and train staff on regulatory expectations ahead of the notified body visit.
Expert Consultation and Support
With our extensive experience in handling over 500 CDSCO license applications, we offer consultative support tailored to your fixed-diameter cervical dilator device. Our services include:
- Gap analysis of your current documentation
- Assistance in compiling DMF and PMF
- Coordination for product testing and notified body audits
- End-to-end application filing and query management
Our expert team ensures you meet all regulatory requirements efficiently, minimizing time-to-market.
Getting Started with Your CDSCO License Application
- Assess your product classification and confirm the need for an MD5 license.
- Register on the CDSCO MD Online Portal to initiate the test license application.
- Identify and liaise with CDSCO-approved testing laboratories early to plan your product testing.
- Prepare and organize your Device Master File and Plant Master File meticulously.
- Schedule an internal audit and compliance check before notified body inspection.
- Submit your MD3 application for the MD5 license after completing test license and product testing.
- Respond promptly to queries raised by CDSCO or the notified body.
By following these structured steps, your fixed-diameter cervical dilator will be on a clear, compliant path toward successful market entry in India.
For more details on the MD5 licensing process, visit our comprehensive MD5 License Guide.
This expert guide aims to empower manufacturers and importers with actionable insights and practical steps based on proven regulatory strategies. Our commitment is to make your CDSCO licensing journey efficient, transparent, and successful.
