CDSCO License for Pusher

Comprehensive CDSCO Licensing Guide for Pusher Dental Instruments (Class A Medical Device)

As seasoned regulatory consultants with over 25 years of experience and having assisted more than 500 companies in securing CDSCO licenses, we understand the nuances involved in bringing medical devices like the Pusher to the Indian market. This hand-held dental instrument, classified under Class A risk and intended for orthodontic use to position and adapt metal bands on teeth, falls within the scope of General Hospital or Orthopaedic Instruments as per the CDSCO notification (29/Misc./03/2020-DC (193)- Part-3 dated 16.03.2022).

Navigating the Indian regulatory landscape effectively is critical to ensuring timely market access and compliance. This comprehensive guide covers everything manufacturers or importers need to know about obtaining a CDSCO manufacturing license (MD5) for your Pusher device.

CDSCO Regulatory Framework for Pusher Dental Instruments

The Central Drugs Standard Control Organization (CDSCO) regulates medical devices in India under the Medical Device Rules, 2017, as amended. Devices like the Pusher, categorized under Class A (low risk), require licensing from the State Licensing Authority through the MD5 license route.

The regulatory framework includes:

• Risk-based classification of devices
• Mandatory test license (MD13) prior to manufacturing license application
• Product testing in CDSCO-approved laboratories
• Quality management system compliance
• Audits by notified bodies

Understanding these steps upfront can significantly reduce delays and ensure smooth approval.

Risk Classification and License Requirements for Pushers

The Pusher dental instrument is classified as Class A under the Medical Device Rules. This classification implies:

• Low risk device
• Requires a Manufacturing License (MD5) from the State Licensing Authority
• Compliance with essential principles and quality standards

For a detailed explanation of risk classes, you can refer to our Medical Device Classification guide.

Manufacturing License Process for Class A Devices (MD5 License)

The MD5 license process encompasses several critical steps:

1. Test License Application (Form MD13):
   • Mandatory to obtain a test license prior to manufacturing license application
   • Processing time: approximately 1.5 to 2 months
2. Product Testing:
   • Conducted at CDSCO-approved laboratories
   • Testing ensures compliance with standards
3. Document Preparation:
   • Compile required documents including Device Master File, Plant Master File, QMS documents, and risk management files
4. Manufacturing License Application (Form MD3):
   • Submit via the CDSCO MD Online Portal
5. Audit by Notified Body:
   • Required for Class A devices
   • Refer to the list of notified bodies
6. Queries and Clarifications:
   • Address any queries raised by CDSCO or notified body
7. Grant of License (Form MD5):
   • Upon successful audit and document verification

Manufacturing License Documents Required for Pushers

Accurate and complete documentation is pivotal. The following are mandatory:

• Company Constitution: Incorporation certificate, partnership deed, or LLP agreement
• Proof of Premises Ownership or Lease: Rent agreement or ownership documents
• Technical Staff Credentials: Qualifications and experience of key personnel
• Fire NOC and Pollution Control NOC: From relevant authorities
• Device Master File (DMF): Detailed device specifications, design, and manufacturing process (Device Master File guide)
• Plant Master File (PMF): Description of manufacturing facilities and quality systems (Plant Master File guide)
• Essential Principles Checklist: Compliance with safety and performance requirements
• Risk Management File: Risk analysis and mitigation strategies (Risk Management guide)
• Test Reports: From CDSCO-approved labs (Testing Laboratories list)
• Labels and Instructions for Use (IFU): As per regulatory standards
• Quality Management System Documents: ISO 13485 certification and internal SOPs

Import License Process (MD15) for Pushers

If you plan to import Pushers into India, the process differs slightly:

• MD15 license is issued by the Central Licensing Authority (CDSCO HQ)
• No test license (MD13) is needed
• Application submitted on Form MD14 through the CDSCO MD Online Portal
• Required documents include Manufacturing License, Free Sale Certificate, ISO 13485:2016, CE Certificate, Device and Plant Master Files, Wholesale License, and Company Constitution
• The processing timeline is approximately 5 to 6 months

For detailed import license procedures, review our Import License guide.

Import License Documents Required

• Valid manufacturing license from the country of origin
• Free Sale Certificate (FSC) or equivalent
• ISO 13485:2016 certificate
• CE Certificate or equivalent quality certification
• Device Master File and Plant Master File
• Wholesale drug license
• Company Constitution / Incorporation documents

Timeline and Processing Duration

Planning ahead for these timelines can help avoid unnecessary delays.

Government Fees and Costs for MD5 License

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

These fees are payable via the CDSCO MD Online Portal. Additional costs include:

• Testing laboratory fees (varies by test scope)
• Audit fees charged by the notified body
• Consultancy fees if engaging regulatory experts

Common Challenges and Solutions

• Incomplete Documentation: Prepare comprehensive files using checklists to avoid rejection.
• Delays in Product Testing: Schedule tests early and select approved labs with shorter lead times.
• Audit Non-Compliance: Conduct internal audits prior to notified body visits.
• Query Management: Respond promptly and clearly to CDSCO queries to prevent processing delays.

Our experience shows that proactive planning and expert guidance significantly reduce these bottlenecks.

Expert Consultation and Support

Navigating CDSCO licensing can be complex, especially for first-time manufacturers or importers. Our team offers:

• End-to-end licensing support
• Document preparation and review
• Audit readiness and compliance consulting
• Liaison with notified bodies and CDSCO officials

We have successfully supported over 500 companies in securing their medical device licenses, including Class A devices like the Pusher.

Getting Started with Your CDSCO License Application

1. Assess your device classification to confirm it falls under Class A.
2. Initiate the Test License application (MD13) via the CDSCO MD Online Portal.
3. Schedule product testing at an approved laboratory early.
4. Prepare comprehensive documentation including Device Master File and Plant Master File.
5. Select a notified body for the audit phase using the notified bodies list.
6. Submit your manufacturing license application (MD3) through the portal once test results and documents are ready.
7. Prepare for the audit and address any queries promptly.

By following these actionable steps and leveraging expert support, you can efficiently secure your CDSCO MD5 license for the Pusher dental instrument and confidently enter the Indian medical device market.

For personalized assistance, feel free to connect with our regulatory experts who specialize in CDSCO licensing for Class A medical devices.

Trust our 25+ years of regulatory expertise to accelerate your medical device licensing journey in India.