CDSCO License for Transcervical(Aminoscope) Endoscope and Accessories
Medical Device Information
Intended Use
It is a device designed to permit direct viewing of the foetus and amniotic sac by means of an open tube introduced into the uterus through the cervix.
Introduction to Transcervical (Aminoscope) Endoscope and Accessories
The Transcervical (Aminoscope) Endoscope is a specialized medical device designed for direct visualization of the fetus and amniotic sac through the cervix. Classified under catheters and designated as a Class B device by the CDSCO, it holds significant clinical importance in obstetrics and gynecology. Navigating the regulatory landscape to obtain the necessary CDSCO license is critical for manufacturers and importers aiming to enter the Indian market with this device.
With over 25 years of experience helping 500+ companies successfully secure CDSCO approvals, we offer detailed, practical guidance on the entire licensing process tailored to this device.
CDSCO Regulatory Framework for Transcervical (Aminoscope) Endoscope
The Central Drugs Standard Control Organization (CDSCO) governs the regulation of medical devices in India through its Medical Device Rules, 2017. The Transcervical (Aminoscope) Endoscope, falling under the catheter category and classified as Class B, is regulated with a focus on ensuring safety, performance, and quality compliance.
This device’s regulatory requirements are primarily managed through the State Licensing Authority under the MD5 manufacturing license for Class A and B devices, making understanding these protocols essential for timely market entry.
Risk Classification and License Requirements for Class B Devices
As a Class B medical device, the Transcervical (Aminoscope) Endoscope is considered low to moderate risk. According to the Medical Device Classification, Class B devices require a manufacturing license under Form MD3 (MD5 license), issued by the State Licensing Authority.
Key license requirements include:
- Obtaining a Test License (Form MD13) prior to manufacturing
- Product testing from CDSCO notified government-approved labs
- Document submission and notified body audit
This structured approach ensures compliance with essential principles and risk management standards.
Manufacturing License Process (MD5) for Class B Devices
The MD5 license process is comprehensive but well-defined, typically spanning 3 to 4 months from application to grant. Here's an actionable stepwise outline:
Test License Application (Form MD13): Apply via the CDSCO MD Online Portal to obtain permission for product testing. This stage takes approximately 1.5 to 2 months.
Product Testing: Submit samples of the Transcervical (Aminoscope) Endoscope and accessories to CDSCO notified testing laboratories. Refer to the Testing Laboratories list for approved facilities.
Documentation Preparation: Compile all required documents including Device Master File, Plant Master File, and risk management evidence.
License Application (Form MD3): Submit the MD5 license application with all supporting documents through the online portal.
Notified Body Audit: Coordinate with a CDSCO notified body for the mandatory facility audit. The list of Notified Bodies is available online.
Query Resolution: Address any queries raised by the licensing authority or notified body promptly.
License Grant: Upon satisfactory review, the State Licensing Authority issues the MD5 license on Form MD5.
We recommend starting early with test license application to streamline subsequent steps.
Manufacturing License Documents Required for Transcervical Endoscope
To ensure a smooth application process, prepare the following key documents:
- Company Constitution: Incorporation certificate, partnership deed, or other relevant legal documents
- Proof of Premises Ownership/Lease: Valid documents confirming business address
- Technical Staff Details: Qualifications and experience of personnel responsible for manufacturing
- Fire NOC and Pollution Control NOC: Mandatory clearances to comply with safety norms
- Device Master File (DMF): Comprehensive details on design, materials, and manufacturing processes. Our detailed Device Master File guide can assist in preparation.
- Plant Master File: Documentation of the manufacturing facility and quality systems. Learn how to create this from our Plant Master File Guide.
- Essential Principles Checklist: Compliance matrix proving adherence to Indian regulatory standards
- Risk Management File: Evidence of risk assessment and mitigation strategies, aligned with ISO 14971 standards. Visit our Risk Management guide for practical tips.
- Test Reports: From CDSCO-approved labs confirming device safety and performance
- Labels and Instructions for Use (IFU): Samples demonstrating compliance with labeling regulations
- Quality Management System (QMS) Documents: Proof of implemented ISO 13485 or equivalent QMS
Ensuring these documents are thorough and accurate reduces back-and-forth with the regulator.
Import License Process (MD15) Overview
For importers of the Transcervical (Aminoscope) Endoscope, the MD15 license is required. Issued by the Central Licensing Authority, this process typically takes 5 to 6 months.
Unlike manufacturing, import licensing does not require a test license but mandates detailed documentation including:
- Valid manufacturing license from the country of origin
- Free Sale Certificate
- ISO 13485:2016 Certification
- CE Certificate or equivalent
- Device and Plant Master Files
- Wholesale License
The application is submitted via the CDSCO MD Online Portal, using Form MD14 for MD15 license application.
For a complete walkthrough, refer to our Import License Guide.
Import License Documents Required
- Manufacturing License from Country of Origin: Official license confirming manufacturing approval
- Free Sale Certificate: Valid document certifying the device is freely sold in the country of origin
- ISO 13485:2016 Certificate: Demonstrating compliance with international quality standards
- CE Certificate or Equivalent: Proof of conformity with European or similar regulations
- Device Master File & Plant Master File: Detailed technical and facility documents
- Wholesale License: License to distribute medical devices in India
- Company Constitution Documents: Legal proof of business entity
Proper document preparation ensures smooth regulatory review.
Timeline and Processing Duration for Transcervical Endoscope Licensing
| License Type | Approximate Timeline | Key Milestones |
|---|---|---|
| MD5 Manufacturing | 3 to 4 months | Test license (1.5-2 months), testing, audit, license grant |
| MD15 Import | 5 to 6 months | Document prep, application, query resolution, license grant |
Early planning and proactive query management can help meet these timelines efficiently.
Government Fees and Costs for MD5 License
- Application Fee: Rs 5,000 per application
- Product Fee: Rs 500 per product
Considering the Transcervical Endoscope falls under Class B, the fees align with these rates. Additional costs include testing fees charged by notified labs and fees for notified body audits.
Budgeting for these expenses upfront avoids surprises during the process.
Common Challenges and Practical Solutions
1. Delays in Test License Approval:
- Solution: Submit complete and accurate application documents; follow up regularly on the CDSCO MD Online Portal.
2. Incomplete or Non-compliant Documentation:
- Solution: Use checklists and templates, such as our Device Master File guide, to ensure completeness.
3. Notified Body Audit Findings:
- Solution: Pre-audit your facility internally and prepare corrective action plans.
4. Product Testing Failures:
- Solution: Engage with CDSCO-approved labs early to understand testing protocols and prepare samples meticulously.
5. Query Resolution Delays:
- Solution: Assign dedicated regulatory personnel for prompt responses.
Our extensive experience means we’ve encountered these issues frequently and can help you navigate them smoothly.
Expert Consultation and Support
Navigating CDSCO licensing for specialized devices like the Transcervical (Aminoscope) Endoscope requires expert knowledge. Our consultancy offers:
- End-to-end application preparation and submission
- Gap analysis for documentation
- Coordination with notified bodies and testing labs
- Pre-audit readiness and compliance training
- Post-license regulatory maintenance support
Partnering with experts ensures compliance and accelerates your time to market.
Getting Started with Your CDSCO License Application
To initiate your licensing journey:
Register on the CDSCO MD Online Portal: Create your company profile and familiarize yourself with the portal interface.
Apply for Test License (MD13): Begin with the test license application to enable product testing.
Engage with CDSCO Notified Testing Labs: Arrange for sample testing promptly upon license receipt.
Prepare Required Documentation: Use our Device and Plant Master File guides to ensure compliance.
Select a Notified Body for Audit: Identify and coordinate with a notified body early using the Notified Bodies list.
Submit Manufacturing License Application (Form MD3): After successful testing, file your MD5 license application.
Maintain Open Communication: Respond to queries swiftly and schedule audits promptly.
Our proven process and detailed checklists will support you at every step to obtain your MD5 manufacturing license for the Transcervical Endoscope efficiently and compliantly.
For personalized assistance and to discuss your specific project needs, contact us today and leverage our 25+ years of regulatory expertise.
