CDSCO License for Rigid video hysteroscope
Medical Device Information
Intended Use
Active device intended to allow visual examination and treatment of the canal of the cervix and the uterine cavity (uterus).
Comprehensive Guide to CDSCO Licensing for Rigid Video Hysteroscope (Class B Medical Device)
As seasoned regulatory consultants with over 25 years of experience and having successfully guided 500+ companies through the CDSCO licensing process, we understand the critical nuances involved in bringing sophisticated medical devices like the Rigid Video Hysteroscope to the Indian market. This active Class B medical device, designed for visual examination and treatment of the cervix and uterine cavity, falls under the obstetrical and gynecological category and requires precise regulatory compliance as per the CDSCO notification File No. 29/Misc./03/2020-DC (181), dated 03.6.2022.
CDSCO Regulatory Framework for Rigid Video Hysteroscope
The Central Drugs Standard Control Organization (CDSCO) governs medical device licensing in India. The Rigid Video Hysteroscope is classified as a Class B device, which mandates a manufacturing license under MD5 (Form MD3) issued by the State Licensing Authority. For importers, an import license under MD15 is necessary, granted by the Central Licensing Authority.
Manufacturers and importers must adhere to the requirements stipulated in the Medical Device Rules, 2017, ensuring adherence to quality, safety, and efficacy standards. The device is actively used for invasive procedures in gynecology, necessitating stringent compliance.
Risk Classification and License Requirements
| Risk Class | Device Examples | License Type | Licensing Authority | Typical Timeline | Fee Structure |
|---|---|---|---|---|---|
| Class A/B | Non-invasive and low-risk devices | MD5 | State Licensing Authority | 3-4 months | Rs. 5000 + Rs. 500 per product |
| Class C/D | High-risk devices | MD9 | Central Licensing Authority | 4-5 months | Rs. 50,000 + Rs. 1000 per product |
| Import | All classes | MD15 | Central Licensing Authority | 5-6 months | Variable (see below) |
Since the Rigid Video Hysteroscope is Class B, the MD5 license process applies.
Manufacturing License Process (MD5) for Rigid Video Hysteroscope
The MD5 license process involves several methodical steps:
Test License (MD13): Before applying for the manufacturing license, companies must obtain a test license on Form MD13, allowing limited manufacture for product testing. This takes approximately 1.5 to 2 months.
Product Testing: The device must be tested in CDSCO-approved laboratories to verify compliance with Essential Principles. You can find the updated list of Testing Laboratories here.
Document Preparation: Compilation of detailed technical and quality documents, including Device Master File (DMF), Plant Master File (PMF), Risk Management File, and Essential Principles Checklist.
License Application (Form MD3): Submit the application through the CDSCO MD Online Portal along with fees.
Audit by Notified Body: An audit of the manufacturing site and QMS is conducted by an approved notified body. Refer to the list of notified bodies.
Resolution of Queries: Address any observations or queries raised by the CDSCO or notified body.
Grant of License (Form MD5): Upon satisfactory review, the manufacturing license is granted.
Manufacturing License Documents Required
Manufacturers must prepare and submit the following documents:
- Company Constitution Documents (Incorporation Certificate, Memorandum & Articles of Association)
- Proof of Ownership or Lease Agreement of Manufacturing Premises
- Technical Staff Details (Qualifications and Experience Certificates)
- Fire NOC and Pollution Control NOC
- Device Master File (DMF): Detailed design, specifications, manufacturing process, and validation data. Our Device Master File guide provides practical steps.
- Plant Master File (PMF): Details on factory layout, equipment, utilities, quality systems. Learn more from our Plant Master File guide.
- Essential Principles Checklist: Demonstrating compliance with CDSCO Essential Principles for Safety and Performance.
- Risk Management File: Documented risk analysis and mitigation strategies. We recommend reviewing our Risk Management guide.
- Test Reports from CDSCO-approved laboratories
- Product Labels and Instructions for Use (IFU)
- Quality Management System (QMS) Documents, including SOPs, CAPA, complaint handling, and calibration records
Import License Process (MD15) for Rigid Video Hysteroscope
For importers intending to bring the Rigid Video Hysteroscope into India, the MD15 license application is mandatory. The process includes:
Document Preparation: Including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016 certification, CE marking, DMF, PMF, and company constitution.
Application Submission: File Form MD14 via the CDSCO MD Online Portal.
Review and Queries: CDSCO may ask for clarifications or additional documents.
License Grant: Upon satisfactory evaluation, the import license (Form MD15) is issued.
No test license is required for import applications.
Import License Documents Required
- Valid Manufacturing License from the country of origin
- Free Sale Certificate with device details
- ISO 13485:2016 Certification
- CE Certificate (if applicable)
- Device Master File (DMF)
- Plant Master File (PMF)
- Wholesale License (if applicable within India)
- Company Constitution Documents
Timeline and Processing Duration
| Process Step | Estimated Duration |
|---|---|
| Test License (MD13) | 1.5-2 months |
| Product Testing | 2-3 weeks |
| Document Preparation | Concurrent with Testing |
| License Application | Immediate after testing |
| Audit and Inspection | 4-6 weeks |
| Query Resolution | 2-4 weeks |
| Total MD5 License | Approximately 3-4 months |
For import license (MD15), the total process generally takes 5-6 months due to document verification and administrative review.
Government Fees and Costs
For the Rigid Video Hysteroscope (Class B device) manufacturing license:
- Application Fee: Rs. 5000 per application
- Product Fee: Rs. 500 per product
Additional costs include:
- Testing fees at CDSCO-approved labs (varies by test complexity)
- Audit fees charged by notified bodies
- Consultation and documentation preparation (if outsourced)
For imports, fees depend on device class and number of products. For Class B devices, expect fees roughly:
- Rs. 40,000 to Rs. 60,000 per site
- Rs. 500 to Rs. 1000 per product
Our clients often budget for these fees upfront to avoid delays.
Common Challenges and Solutions
Challenge 1: Delays in test license approval
- Solution: Prepare complete and accurate forms with all required documents to avoid back-and-forth communication.
Challenge 2: Difficulty in obtaining comprehensive test reports
- Solution: Engage with CDSCO-approved testing labs early and plan timelines accordingly. Refer to the official Testing Laboratories list.
Challenge 3: Audit non-compliance due to inadequate QMS
- Solution: Implement and maintain a robust Quality Management System aligned with ISO 13485 standards. Conduct internal audits before notified body inspections.
Challenge 4: Incorrect or incomplete documentation
- Solution: Use checklists and templates from expert sources, including our Device Master File guide and MD5 license guide to ensure completeness.
Expert Consultation and Support
Navigating CDSCO regulations can be complex, particularly for innovative devices like the Rigid Video Hysteroscope. Our team offers:
- Customized regulatory strategy planning
- End-to-end license application management
- Documentation preparation and review
- Liaison with CDSCO and notified bodies
- Training on compliance and post-market surveillance
Our extensive experience ensures accelerated approval timelines and minimizes rejections.
Getting Started with Your CDSCO License Application
To initiate your licensing process for the Rigid Video Hysteroscope:
Assess your device classification and confirm it as Class B based on Medical Device Classification.
Register your company on the CDSCO MD Online Portal to access application forms and notifications.
Gather and prepare required documents, leveraging our guides for Device Master File and Plant Master File.
Apply for the Test License (MD13) to begin product testing.
Coordinate with authorized testing laboratories early to schedule product testing.
Prepare your Quality Management System documentation and arrange for notified body audit.
Submit your manufacturing license application (Form MD3) once testing and audits are complete.
Respond promptly to CDSCO queries to avoid delays.
By following these practical steps, you position your Rigid Video Hysteroscope for successful entry into the Indian market with full regulatory compliance. For personalized assistance and turnkey solutions, reach out to our expert team today.
For more detailed insights, visit our MD5 License Guide and Import License Guide.
