CDSCO License for TEM/TEO rectoscope, video

Comprehensive Guide to CDSCO Licensing for TEM/TEO Rectoscope Video (Class B Medical Device)

Navigating the regulatory landscape for medical devices in India can be complex, especially for specialized equipment like the TEM/TEO rectoscope video. This rigid endoscope is designed specifically for minimally invasive surgical treatment of the lower bowel via transanal endoscopic microsurgery (TEM) or transanal endoscopic operations (TEO), falling under the gastroenterology device category. With a risk classification of Class B, it requires adherence to specific CDSCO licensing pathways to legally manufacture or import in India.

At our consultancy, with over 25 years of experience and a portfolio of 500+ successful CDSCO approvals, we understand the nuances manufacturers and importers face. Below is a detailed, actionable roadmap tailored specifically for the TEM/TEO rectoscope video.

CDSCO Regulatory Framework for TEM/TEO Rectoscope Video

The Central Drugs Standard Control Organization (CDSCO) governs the regulation of medical devices in India under the Medical Devices Rules, 2017. The TEM/TEO rectoscope, being a Class B device, is subject to regulatory oversight by the State Licensing Authority for manufacturing licenses and the Central Licensing Authority for import licenses.

The device is officially notified under Notification Number 29/Misc./03/2020-DC (182) dated 27.09.2021, which underpins its regulatory classification and compliance requirements.

Risk Classification and License Requirements for Class B Devices

Class B devices like the TEM/TEO rectoscope are considered low to moderate risk. Consequently, the license type applicable is the MD5 Manufacturing License, which is issued by the State Licensing Authority. For importers, the MD15 Import License from the Central Licensing Authority is mandatory.

The MD5 license application process is detailed and requires a test license (MD13), product testing, audit by a notified body, and comprehensive documentation.

For an in-depth understanding of medical device classification, manufacturers can refer to the Medical Device Classification guide.

Manufacturing License Process (MD5) for TEM/TEO Rectoscope Video

Step 1: Obtain Test License (Form MD13)

Before applying for the manufacturing license, manufacturers must apply for a Test License on Form MD13. This license permits the testing of the device in government-approved laboratories.

Processing time: Approximately 1.5 to 2 months
Purpose: Enables product testing and validation as per Essential Principles
Testing labs: Testing must be done at CDSCO-approved labs; see the list of testing laboratories for options.

Step 2: Product Testing

The TEM/TEO rectoscope must undergo rigorous testing for safety and performance parameters, including electrical safety, biocompatibility, and functional efficacy.

Step 3: Document Preparation

After test reports are received, the next step includes preparing the full dossier:

Device Master File (DMF) detailing device design and specifications
Plant Master File (PMF) describing manufacturing facilities
Risk Management File outlining risk analysis and mitigation
Essential Principles Checklist
Quality Management System (QMS) documentation (ISO 13485:2016 compliance)
Product labels, Instructions for Use (IFU)

Our comprehensive Device Master File guide and Plant Master File guide can help streamline this process.

Step 4: Application Submission on CDSCO MD Online Portal

Submit the manufacturing license application using Form MD3 through the CDSCO MD Online Portal. Ensure all documents are uploaded correctly to avoid delays.

Step 5: Audit by Notified Body

An audit of your manufacturing facility will be conducted by a notified body listed on the Notified Bodies List for MD5 Audit. The audit evaluates compliance with GMP, QMS, and regulatory requirements.

Step 6: Resolution of Queries

Post-audit, the CDSCO and the notified body may raise queries requiring clarification or additional documentation. Prompt and comprehensive responses are critical.

Step 7: Grant of MD5 License

Upon satisfactory review and audit, the State Licensing Authority will grant the MD5 manufacturing license on Form MD5.

Manufacturing License Documents Required for TEM/TEO Rectoscope Video

Company Constitution and Registration Proof
Proof of Premises Ownership or Lease Agreement
Details of Technical Staff (Qualifications and Experience)
Fire NOC and Pollution Control NOC
Device Master File (DMF)
Plant Master File (PMF)
Essential Principles Checklist
Risk Management File (per ISO 14971 standards)
Test Reports from approved labs
Product Labels and Instructions for Use (IFU)
Quality Management System (QMS) Documents including ISO 13485 certificate

Ensuring all documents are comprehensive and updated significantly minimizes processing delays.

Import License Process (MD15) for TEM/TEO Rectoscope Video

Manufacturers or importers seeking to bring the TEM/TEO rectoscope into India must apply for the MD15 Import License with the Central Licensing Authority.

Key Steps:

Document preparation (Manufacturing License from country of origin, Free Sale Certificate, ISO 13485:2016, CE Certificate, Device and Plant Master Files)
Application submission on Form MD14 via the CDSCO MD Online Portal
Review and queries resolution
License grant on Form MD15

No test license is required for import applications.

Import License Documents Required

Valid Manufacturing License from the country of origin
Free Sale Certificate
ISO 13485:2016 Certification
CE Certificate (if applicable)
Device Master File and Plant Master File
Wholesale License in India
Company Constitution

Timeline and Processing Duration

MD5 Manufacturing License: Total 3-4 months
- Test License (MD13): 1.5-2 months
- Product Testing: 3-4 weeks
- Audit & Review: 4-6 weeks
- License Grant: 2-4 weeks
MD15 Import License: Approximately 5-6 months

Planning for these timelines upfront helps avoid rushed submissions and costly errors.

Government Fees and Costs

MD5 License: Rs. 5000 per application + Rs. 500 per product
MD15 Import License: Class B devices typically incur fees of around $2000 per site +$ 1000 per product

Budgeting for fees alongside testing and consultancy costs ensures smooth financial planning.

Common Challenges and Solutions

Challenge: Delays in test report acquisition

Tip: Engage early with approved labs and schedule testing well in advance.

Challenge: Audit non-compliance findings

Tip: Conduct pre-audit internal assessments and address gaps proactively.

Challenge: Incomplete or inconsistent documentation

Tip: Use standardized templates and cross-verify documents for coherence.

Challenge: Query resolution delays

Tip: Assign dedicated regulatory personnel for prompt and accurate responses.

Our extensive experience enables us to anticipate these pain points and guide clients through every hurdle.

Expert Consultation and Support

Navigating CDSCO licensing for a specialized device like the TEM/TEO rectoscope video is challenging but manageable with expert support. Our consultancy offers:

End-to-end application drafting and submission
Gap analysis of technical documentation
Coordination with notified bodies and testing labs
Pre-audit readiness assessments
Post-approval compliance management

By leveraging our 25+ years of expertise, manufacturers significantly reduce approval times and compliance risks.

Getting Started with Your CDSCO License Application

Assess your device classification and license type: Confirm Class B status and prepare for MD5 licensing.
Gather core documents: Initiate preparation of Device Master File, Plant Master File, Risk Management File, and QMS documentation.
Engage a notified testing laboratory: Schedule testing promptly to align with application timelines.
Apply for the Test License (MD13): Submit early to avoid bottlenecks.
Plan audit readiness: Begin GMP and QMS assessments.
Submit your MD5 application via the CDSCO MD Online Portal: Ensure all documents are complete and formatted as per CDSCO guidelines.

Starting early and following a structured approach will set you on a clear path to obtaining your CDSCO license for the TEM/TEO rectoscope video.

For detailed assistance, please connect with our regulatory experts who have successfully guided over 500 companies through this process. Together, we can help you bring your innovative gastroenterology device safely and compliantly to the Indian market.