CDSCO License for Rigid ultrasound laparoscope
Medical Device Information
Intended Use
An endoscope with a rigid inserted portion, combined with an ultrasound probe, intended for the visual examination, treatment, and ultrasonic imaging of the abdominal/retroperitoneal cavity and its organs

Introduction to Rigid Ultrasound Laparoscope and Regulatory Importance
The rigid ultrasound laparoscope is a sophisticated medical device combining rigid endoscopy with ultrasound imaging, primarily used for visual examination, treatment, and ultrasonic imaging of the abdominal and retroperitoneal cavities. Categorized under obstetrical and gynecological devices, this instrument plays a critical role in minimally invasive diagnostics and surgeries.
Given its complexity and risk profile (Class B), stringent regulatory compliance is mandatory before marketing in India. The Central Drugs Standard Control Organization (CDSCO) oversees the licensing and quality control of such medical devices to ensure patient safety and device efficacy. Navigating the CDSCO licensing landscape can be challenging, but with our 25+ years of experience assisting over 500 companies, we provide clear, actionable guidance tailored specifically for devices like the rigid ultrasound laparoscope.
CDSCO Regulatory Framework for Rigid Ultrasound Laparoscope
The CDSCO regulates medical devices based on their risk classification, intended use, and technology. For the rigid ultrasound laparoscope, classified as Class B, the regulatory framework demands a manufacturing license known as the MD5 license, issued by the State Licensing Authority. Importers require a separate MD15 license from the Central Licensing Authority.
This device falls under the notification File No. 29/Misc./03/2020-DC (181) dated 03.06.2022, emphasizing compliance with the latest regulatory amendments.
Risk Classification and License Requirements
According to CDSCO classification, Class B devices are considered low-to-moderate risk. Examples include non-invasive devices that interact with internal body parts but do not pose significant risk to life or health. The rigid ultrasound laparoscope, combining optical and ultrasound technology, fits firmly in this category.
License Types for Class B Devices:
- MD5 License (Manufacturing License): Required to manufacture Class B devices within India. This license is issued by the State Licensing Authority.
- MD15 License (Import License): Required for importing Class B devices, issued by the Central Licensing Authority.
Manufacturing License Process for Rigid Ultrasound Laparoscope (MD5 License)
The process to obtain the MD5 manufacturing license involves several critical steps:
- Test License (Form MD13): Before applying for MD5, manufacturers must secure a test license. This allows initial production and product testing.
- Product Testing: Samples must be tested at CDSCO-approved laboratories to verify compliance with Indian standards.
- Document Preparation: Compile all necessary documents including Device Master File, Plant Master File, risk management files, and quality manuals.
- Application Submission (Form MD3): Submit the manufacturing license application online via the CDSCO MD Online Portal.
- Audit by Notified Body: A notified body performs an audit of manufacturing facilities and quality systems. Find the list of notified bodies here.
- Query Resolution: Address any queries raised by the CDSCO or notified body.
- Grant of License (Form MD5): Upon satisfactory compliance, the license is granted.
Timeline:
- Test License: 1.5 to 2 months
- Product Testing: 3 to 4 weeks
- Audit and Query Resolution: 1 to 1.5 months
- Total Process: Approximately 3 to 4 months
Manufacturing License Documents Required
For the rigid ultrasound laparoscope, the following documents must be prepared meticulously:
- Company Constitution and Incorporation Certificate
- Proof of Ownership or Lease of Manufacturing Premises
- Qualification and Experience Certificates of Technical Staff
- Fire NOC and Pollution Control NOC
- Device Master File (DMF) detailing design, specifications, and manufacturing process (DMF Guide)
- Plant Master File (PMF) describing manufacturing facilities (PMF Guide)
- Essential Principles Checklist confirming compliance with Indian Medical Device Rules
- Risk Management File demonstrating identification and mitigation of potential hazards (Risk Management Guide)
- Test Reports from CDSCO-recognized labs (Testing Laboratories List)
- Labels and Instructions for Use (IFU) complying with labeling requirements
- Quality Management System (QMS) Documents, preferably ISO 13485:2016 certification
Import License Process for Rigid Ultrasound Laparoscope (MD15 License)
Manufacturers and distributors looking to import the rigid ultrasound laparoscope into India must apply for the MD15 import license, granted by the Central Licensing Authority.
Steps include:
- Document Preparation: Gather manufacturing license from the country of origin, Free Sale Certificate, ISO 13485 certification, CE certificate, and other technical documentation.
- Application Submission (Form MD14): Submit the application online via the CDSCO MD Online Portal.
- Queries and Clarifications: Respond promptly to any departmental queries.
- Grant of License (Form MD15): Upon approval, the import license is issued.
Documents Required:
- Valid manufacturing license of the foreign manufacturer
- Free Sale Certificate from the country of origin
- ISO 13485:2016 Certification
- CE Mark Certificate (if applicable)
- Device Master File and Plant Master File
- Wholesale Drug License for the importer
- Company Incorporation Certificate
Timeline:
- Typically 5 to 6 months from application submission to license grant
Government Fees and Costs
MD5 License Fees (Class B):
- Application Fee: Rs. 5,000
- Per Product Fee: Rs. 500
MD15 License Fees (Import of Class B Devices):
- Site Fee: $2,000 USD
- Per Product Fee: $1,000 USD
Note: Fees are payable online at the time of application via the CDSCO portal.
Common Challenges and Solutions
Challenge 1: Delayed Test License and Product Testing
- Solution: Pre-plan sample submission to approved labs listed on the CDSCO portal. Maintain clear communication with labs to expedite testing.
Challenge 2: Preparing Comprehensive and Compliant DMF and PMF
- Solution: Utilize detailed templates and guides such as our Device Master File Guide and Plant Master File Guide.
Challenge 3: Audit Non-Conformities
- Solution: Conduct internal mock audits and ensure QMS aligns with ISO 13485 standards before notified body inspection.
Challenge 4: Regulatory Queries and Documentation Gaps
- Solution: Engage experienced regulatory consultants early to prepare precise responses and rectify documentation.
Expert Consultation and Support
Our team, with over 25 years specializing in CDSCO licensing, has successfully guided more than 500 clients through the complex regulatory pathways for devices like the rigid ultrasound laparoscope. We offer:
- End-to-end license application management
- Documentation preparation and review
- Mock audits and compliance gap analysis
- Liaison with notified bodies and CDSCO officials
- Post-approval support and license renewals
Getting Started with Your CDSCO License Application
If you manufacture or plan to import the rigid ultrasound laparoscope in India, the first practical step is to register on the CDSCO MD Online Portal. Next, determine if you require a test license (MD13) for manufacturing or proceed directly with the import license application (MD15).
We recommend conducting a thorough gap analysis of your existing documentation and quality systems against CDSCO requirements. Early engagement with a notified body and accredited testing laboratories will streamline your path.
To expedite your compliance journey, contact us to schedule a detailed consultation. Together, we can prepare a robust application package tailored to your device’s unique specifications and regulatory expectations, ensuring timely approval and market access.
Embark on your CDSCO licensing journey confidently with expert guidance and practical support designed for success in India’s dynamic medical device market.