CDSCO License for ENT cupped forceps

Comprehensive Guide to CDSCO Licensing for ENT Cupped Forceps (Class A Medical Device)

As a trusted regulatory consultancy with over 25 years of experience and having supported 500+ medical device companies, we understand the nuances and challenges involved in obtaining CDSCO licenses in India. This guide focuses on the ENT cupped forceps, a Class A medical device categorized under ENT instruments, with notification number 29/Misc/03/2020-DC(196) dated 06.08.2021.

Understanding the ENT Cupped Forceps and Its Regulatory Significance

ENT cupped forceps are specialized surgical instruments with a spoon-shaped distal end, designed to assist in the removal of tissues from the ear, nose, and throat regions. Given their direct use in invasive procedures, regulatory oversight ensures safety, efficacy, and quality compliance before these devices can enter the Indian market.

CDSCO Regulatory Framework for ENT Cupped Forceps

In India, medical devices are regulated under the Ministry of Health and Family Welfare via the Central Drugs Standard Control Organization (CDSCO). The ENT cupped forceps fall under Class A (low risk), which means the manufacturing license is issued by the State Licensing Authority via the MD5 license.

This classification and regulatory requirement are based on the CDSCO Medical Device Classification guidelines and the official notification 29/Misc/03/2020-DC(196).

Risk Classification and License Requirements for Class A Devices

• Risk Class: A (Low risk)
• Regulatory Authority: State Licensing Authority
• License Type: Manufacturing License MD5 (Form MD3)
• Additional Requirements: Test license (MD13), product testing from CDSCO-approved labs

Step-by-Step Manufacturing License Process for ENT Cupped Forceps (MD5 License)

1. Obtain Test License (Form MD13):

   • Mandatory before manufacturing.
   • Processing time: 1.5 to 2 months.
   • Allows manufacturing of limited quantity for testing.

2. Product Testing:

   • Samples must be sent to government-approved testing laboratories.
   • Refer to the list of approved testing laboratories for selection.
   • Testing duration varies but typically takes 4-6 weeks.

3. Prepare Required Documentation:

   • Comprehensive document compilation as detailed in the next section.

4. Apply for Manufacturing License (Form MD3) on MD Online Portal:

   • Submit application via the CDSCO MD Online Portal.

5. Audit by Notified Body:

   • Audit conducted by a notified body listed on the Notified Bodies List.
   • Ensures compliance with QMS and regulatory requirements.

6. Resolve Queries:

   • Address any queries from CDSCO or the notified body promptly to avoid delays.

7. Grant of License (Form MD5):

   • Upon satisfactory compliance, license is issued.

Manufacturing License Documents Required for ENT Cupped Forceps

For a smooth approval process, ensure you have the following documents ready:

• Company Constitution (e.g., MOA, AOA)
• Proof of Ownership or Lease Agreement of Manufacturing Premises
• Details and Qualifications of Technical Staff
• Fire No Objection Certificate (NOC)
• Pollution Control Board NOC
• Device Master File (DMF) – covering design, manufacturing process, and specifications (Device Master File Guide)
• Plant Master File (PMF) – detailing the manufacturing facility and quality systems (Plant Master File Guide)
• Essential Principles Checklist compliant with Indian regulations
• Risk Management File according to ISO 14971 principles (Risk Management Guide)
• Test Reports from government-approved labs
• Labels and Instructions for Use (IFU) complying with CDSCO standards
• Quality Management System (QMS) Documents – typically ISO 13485:2016 certification is preferred

Import License Process for ENT Cupped Forceps (If Applicable)

If you are an importer rather than a manufacturer, you need an MD15 import license granted by the Central Licensing Authority.

• Application Form: MD14 for MD15 license
• Timeline: Approximately 5-6 months
• Documents Required: Manufacturing license from country of origin, Free Sale Certificate, ISO 13485, CE certificate (if applicable), Device Master File, Plant Master File, Wholesale License, Company Constitution
• Government Fees: Class A devices incur $1000 per site and$50 per product
• Application is submitted via the CDSCO MD Online Portal

For detailed steps, see our Import License Guide.

Timeline and Processing Duration for ENT Cupped Forceps License

Government Fees and Costs

• Application fee: Rs 5,000 per application
• Product fee: Rs 500 per product

Additional costs to consider:

• Testing lab fees (varies by lab and tests required)
• Notified body audit fees
• Internal resource allocation for documentation and compliance

Common Challenges and Practical Solutions

Challenge 1: Delays in product testing

• Solution: Early coordination with testing labs and submitting complete samples can minimize delays.

Challenge 2: Incomplete documentation leading to queries

• Solution: Use comprehensive checklists and expert review before submission.

Challenge 3: Audit non-compliance issues

• Solution: Conduct internal audits and gap assessments prior to the notified body visit.

Challenge 4: Understanding complex regulatory language

• Solution: Engage experienced regulatory consultants who specialize in CDSCO licenses.

Expert Consultation and Support

Navigating CDSCO regulations can be complex, especially with evolving guidance and notifications. As a seasoned consultancy with 25+ years of experience, we provide end-to-end support including:

• Device classification and regulatory strategy
• Document preparation and review
• Coordination with notified bodies and testing labs
• Application submission and query handling

Our proven track record with over 500 successful client approvals ensures you avoid common pitfalls and expedite your license grant.

Getting Started with Your CDSCO License Application for ENT Cupped Forceps

1. Assess your manufacturing setup and ensure compliance with QMS and facility requirements.
2. Compile your Device Master File and Plant Master File according to CDSCO standards.
3. Apply for the test license (Form MD13) through the CDSCO MD Online Portal.
4. Coordinate with government-approved testing laboratories early to plan sample testing.
5. Engage a notified body for your planned audit – select from the official Notified Bodies List.
6. Prepare all supporting documents meticulously to avoid delays during review.
7. Submit your manufacturing license application (Form MD3) promptly after completing test license and testing.

By following these actionable steps and leveraging expert guidance, you can position your ENT cupped forceps manufacturing business for a successful and timely CDSCO approval.

For tailored assistance and comprehensive support, feel free to reach out to our regulatory experts who specialize in medical device licensing for India.