CDSCO License for Instrument set for Bone Screws & Plates

Comprehensive Guide to CDSCO Licensing for Instrument Set for Bone Screws & Plates (Class A Medical Device)

Navigating the regulatory landscape for medical devices in India demands precision, expertise, and thorough preparation. As a medical device regulatory consultancy with over 25 years of experience helping 500+ companies secure CDSCO licenses, we provide you with an in-depth, practical guide specifically tailored for the Instrument Set for Bone Screws & Plates—a Class A medical device under the general hospital or orthopedic instruments category.

Understanding the Device and Its Regulatory Importance

The Instrument Set for Bone Screws & Plates includes components such as taps, countersink shafts, tension devices (Muller type), bending irons, direct measuring devices, and more. It is critical to note that this set does not include orthopedic implants, positioning it clearly within the Class A (low risk) category as per CDSCO's classification.

Due to its surgical application, ensuring compliance with CDSCO regulations not only facilitates market access but also guarantees patient safety and device efficacy. The recent notification (29/Misc./03/2020-DC (193)- Part-3 dated 16.03.2022) further solidifies the regulatory framework applicable to this device.

CDSCO Regulatory Framework for Instrument Set for Bone Screws & Plates

The Central Drugs Standard Control Organization (CDSCO) governs medical device licensing in India. For Class A devices like this instrument set, the regulatory pathway is managed by the State Licensing Authority through the issuance of an MD5 Manufacturing License.

The regulatory journey encompasses several steps:

Obtaining a Test License (Form MD13)
Product testing at CDSCO-approved laboratories
Preparation and submission of the manufacturing license application (Form MD3)
Audit by a notified body
Resolution of queries and compliance checks
Grant of the manufacturing license (Form MD5)

You can initiate your application through the CDSCO MD Online Portal, which streamlines the process.

Risk Classification and License Requirements for This Device

As a Class A device, the Instrument Set for Bone Screws & Plates is categorized as low risk. Consequently, the MD5 license is required for manufacturing. This license is processed by the State Licensing Authority and involves:

Test License (Form MD13) for initial product testing
Product testing in government-approved labs
Documentation and audit
Compliance with Essential Principles and risk management protocols

For a detailed understanding of device classification, visit our Medical Device Classification guide.

Manufacturing License Process (MD5) for Class A Devices

The MD5 license process typically spans 3 to 4 months and includes the following practical steps:

Apply for Test License (Form MD13): This initial license allows you to carry out product testing. It usually takes 1.5 to 2 months.
Product Testing: Conduct product testing at CDSCO-recognized laboratories. Refer to the list of testing laboratories for suitable options.
Document Preparation: Compile all required documents comprehensively.
Submit Manufacturing License Application (Form MD3) via the CDSCO MD Online Portal.
Audit by a Notified Body: The audit verifies your compliance with manufacturing and quality standards. Check the list of notified bodies to select the appropriate agency.
Queries Resolution: Address any questions or clarifications raised by the department or notified body.
Grant of MD5 License: Upon satisfactory compliance, the license is granted.

For an in-depth stepwise guide, explore our MD5 License Guide.

Manufacturing License Documents Required for Instrument Set for Bone Screws & Plates

To ensure a smooth application process, the following documents must be meticulously prepared:

Company Constitution or Incorporation Documents
Proof of Ownership or Rental Agreement of Manufacturing Premises
Technical Staff Qualification and Experience Details
Fire No Objection Certificate (NOC)
Pollution Control Board NOC
Device Master File (DMF): Contains detailed specs and design controls. Our Device Master File guide provides comprehensive insights.
Plant Master File (PMF): Includes manufacturing processes and quality controls. Learn how to create a PMF here.
Essential Principles Checklist: Demonstrates compliance with CDSCO’s Essential Principles.
Risk Management File: Documenting risk assessment and mitigation strategies. For implementation, see our Risk Management guide.
Product Test Reports from Government Approved Labs
Labels and Instructions for Use (IFU)
Quality Management System (QMS) Documents: Typically ISO 13485:2016 certification or equivalent.

Import License Process (MD15) for This Device

While we primarily focus on the manufacturing license in this guide, importers of this device must obtain an MD15 Import License from the Central Licensing Authority.

This process takes approximately 5 to 6 months and requires documentation such as:

Manufacturing License of the foreign manufacturer
Free Sale Certificate
ISO 13485:2016 Certification
CE Certificate (if applicable)
Device Master and Plant Master Files
Wholesale License
Company Constitution

The application is submitted via Form MD14 on the CDSCO MD Online Portal. For detailed steps, refer to our Import License Guide.

Timeline and Processing Duration

Step	Duration
Test License (Form MD13)	1.5 – 2 months
Product Testing	2 – 4 weeks
Application Preparation & Submission (MD3)	2 – 4 weeks
Audit by Notified Body	3 – 6 weeks
Query Resolution	2 – 4 weeks
Total Estimated Time	3 – 4 months

Government Fees and Costs

The fee structure for MD5 licenses is transparent and affordable:

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

Additional costs include:

Testing fees at government-approved laboratories (varies by test scope)
Audit fees charged by notified bodies
Consultancy or document preparation services (optional but recommended)

Common Challenges and Solutions

Challenge 1: Delays in Product Testing

Solution: Engage early with notified testing labs listed on the CDSCO portal to schedule tests promptly.

Challenge 2: Incomplete or Non-Compliant Documentation

Solution: Use checklists and templates for Device Master File, Risk Management, and QMS documentation. Our guides are invaluable resources.

Challenge 3: Audit Non-Conformities

Solution: Conduct internal audits and gap analysis before the official audit. Address potential issues proactively.

Challenge 4: Resolution of Department Queries

Solution: Prepare well-structured responses with supporting evidence. Maintain open communication with regulatory officials.

Expert Consultation and Support

With two and a half decades of regulatory consultancy experience, we assist manufacturers and importers in:

Document preparation tailored to your device and operations
Scheduling and managing product testing
Coordinating audits with notified bodies
Handling regulatory communications and query resolutions
Navigating post-license compliance and renewals

Our proven track record with over 500 successful CDSCO license grants underscores our commitment to your market success.

Getting Started with Your CDSCO License Application

To embark on your licensing journey for the Instrument Set for Bone Screws & Plates, we recommend the following practical next steps:

Assess Your Device Classification: Confirm Class A status and licensing requirements using the Medical Device Classification resource.
Prepare Preliminary Documents: Begin compiling your Device Master File and Plant Master File. Utilize our comprehensive guides to ensure compliance.
Apply for Test License (MD13): Submit this application via the CDSCO MD Online Portal.
Engage with Approved Testing Laboratories: Schedule product testing promptly to avoid delays.
Plan for Audit: Identify a notified body from the official list and initiate communication.
Consult with Experts: Consider professional regulatory consultation to streamline your application process and prevent costly errors.

Taking these actionable steps will position your company for a successful CDSCO MD5 manufacturing license application, enabling you to supply high-quality orthopedic instrument sets to the Indian healthcare market with confidence.

For personalized assistance or to kickstart your application process, reach out to our regulatory experts who have guided hundreds of companies through the complexities of CDSCO licensing. Together, we can ensure your product reaches the market swiftly and compliantly.

CDSCO License for Instrument set for Bone Screws & Plates

Medical Device Information

Important Notice for Class A Devices

Intended Use