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CDSCO License for Adenotome

Medical Device Information

Important Notice for Class A Devices

Class A Non-sterile Non Measuring devices are exempt from MD5 and MD15 licenses. Only CDSCO registration is required as per GSR 777(E).

Device Class
Class A

Intended Use

Surgical instrument intended to dissect the adenoids.

Manufacturing License
MD5
Import License
MD15
CDSCO License for Adenotome

Comprehensive Guide to CDSCO Licensing for Adenotome: Class A Surgical ENT Device

Introduction: Understanding Adenotome and Regulatory Importance

Adenotome is a specialized surgical instrument designed specifically to dissect the adenoids, playing a critical role in ENT (Ear, Nose, and Throat) surgeries. As a Class A medical device under the Indian regulatory framework, Adenotome is considered low risk but still requires strict compliance with the Central Drugs Standard Control Organization (CDSCO) regulations for manufacturing and marketing in India.

Given the vital nature of Adenotome in surgical procedures, regulatory approval ensures that the device meets safety, quality, and efficacy standards, protecting patients and healthcare providers alike. With over 25 years of experience and having assisted 500+ companies, we understand the nuances of obtaining a CDSCO license for devices like Adenotome and have distilled practical guidance to help manufacturers and importers navigate the process efficiently.

CDSCO Regulatory Framework for Adenotome

The CDSCO regulates medical devices under the Medical Device Rules (MDR) 2017, categorizing devices by risk. Adenotome, falling under Class A (low risk), requires compliance primarily with the State Licensing Authority through the MD5 license process.

The official notification governing Adenotome is 29/Misc/03/2020-DC(196), dated 06.08.2021, confirming its classification and regulatory pathway.

Risk Classification and License Requirements for Adenotome

  • Risk Class: A (Low risk)
  • License Type: Manufacturing License MD5
  • Authority: State Licensing Authority
  • Application Form: MD3

Class A devices like Adenotome require a manufacturing license (MD5) issued by the State Licensing Authority, following successful audit and product testing.

Manufacturing License Process for Adenotome (MD5)

The MD5 license process is multi-step and typically spans 3 to 4 months. Here is the detailed flow:

  1. Test License Application (Form MD13):

  2. Product Testing:

    • Conduct mandatory testing at CDSCO-approved laboratories.
    • Refer to the List of Testing Laboratories.
    • Testing ensures compliance with Essential Principles and performance standards.
  3. Preparation of Technical Documentation:

    • Includes Device Master File, Plant Master File, Risk Management File, QMS documents, and more.
  4. Application for Manufacturing License (Form MD3):

    • File the MD5 license application on the CDSCO portal.
  5. Audit by Notified Body:

    • A notified body conducts an on-site audit of manufacturing facilities.
    • Check the Notified Bodies List.
  6. Resolution of Queries:

    • Address any observations from the audit or CDSCO.
  7. Grant of License (Form MD5):

    • Upon satisfactory compliance, CDSCO issues the manufacturing license.

Manufacturing License Documents Required for Adenotome

To ensure smooth processing, prepare the following documents:

  • Company Constitution (e.g., MOA, AOA)
  • Proof of ownership/lease of manufacturing premises
  • Details of technical staff qualifications and experience
  • Fire NOC and Pollution Control NOC
  • Device Master File (DMF) detailing Adenotome design and specifications (Device Master File Guide)
  • Plant Master File (PMF) describing manufacturing processes and quality controls (Plant Master File Guide)
  • Essential Principles Checklist confirming compliance with Indian MDR
  • Risk Management File demonstrating risk assessment and mitigation (Risk Management)
  • Test Reports from CDSCO-approved labs
  • Product labels and Instructions for Use (IFU)
  • Quality Management System (QMS) documentation (ISO 13485 compliant preferred)

Import License Process for Adenotome (MD15)

If you intend to import Adenotome into India, an MD15 import license granted by the Central Licensing Authority is mandatory. The process includes:

  • Preparation of documentation including Manufacturing License, Free Sale Certificate from the country of origin, ISO 13485:2016 certification, CE certificate if applicable, Device and Plant Master Files, Wholesale License, and Company Constitution.
  • Application submission on the CDSCO portal using Form MD14.
  • Resolution of queries from CDSCO.
  • License grant on Form MD15.

The import license process generally takes 5 to 6 months.

For detailed insights, consult our Import License Guide.

Import License Documents Required

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

Timeline and Processing Duration

StepDuration
Test License (MD13)1.5 to 2 months
Product Testing1 to 1.5 months
Document Preparation2 to 3 weeks
MD5 License Application & Audit1 to 1.5 months
Query Resolution & License Grant2 to 3 weeks

Total Time: Approximately 3 to 4 months.

Government Fees and Costs

  • Test License Fee: Included in application processing
  • MD5 Manufacturing License Fee: Rs 5,000 per application
  • Product Fee: Rs 500 per product (Adenotome counts as one product)

Note: Fees are payable online through the CDSCO portal.

Common Challenges and Solutions

Challenge: Delays due to incomplete documentation or inadequate Device Master File. Solution: Engage experts to prepare and review documents thoroughly, referencing our Device Master File Guide.

Challenge: Difficulty coordinating with notified bodies for audits. Solution: Schedule audit appointments early and select notified bodies from the official Notified Bodies List.

Challenge: Testing failures or delays at labs. Solution: Choose CDSCO-approved testing labs with relevant experience, as detailed in the Testing Laboratories list.

Expert Consultation and Support

Navigating the CDSCO licensing landscape for Adenotome can be complex. Our seasoned regulatory consultants provide end-to-end support—from documentation, test license application, audit coordination, to final license grant.

With our proven track record helping over 500 companies achieve timely approvals, we offer:

  • Tailored document preparation and gap analysis
  • Assistance in selecting notified bodies and testing labs
  • Proactive query management and representation with CDSCO
  • Training for in-house regulatory teams

Getting Started with Your CDSCO License Application for Adenotome

  1. Assess your readiness: Ensure your manufacturing facility complies with Good Manufacturing Practices (GMP) and that your team is qualified.

  2. Prepare documentation: Begin compiling the Device Master File, Plant Master File, Risk Management File, and other mandatory documents.

  3. Apply for Test License (MD13): Register and submit your application on the CDSCO MD Online Portal.

  4. Plan product testing: Coordinate with approved laboratories early to avoid delays.

  5. Schedule notified body audit: Choose a notified body from the official list and book your audit slot.

  6. Submit Manufacturing License (MD5) application: After successful testing and audit, apply through the portal.

  7. Respond promptly to queries: Address all CDSCO and audit observations swiftly to expedite license grant.

By following these practical steps and leveraging expert guidance, manufacturers and importers can successfully bring Adenotome to the Indian market, ensuring compliance and patient safety.

For more detailed assistance, please reach out to our regulatory team to get started on your CDSCO license journey.

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About the Author

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Tails Azimuth
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