CDSCO License for Reamer & its attachment

Comprehensive Guide to CDSCO Licensing for Reamer & Its Attachments (Class A Medical Device)

As seasoned medical device regulatory consultants with over 25 years of experience and having supported 500+ companies, we understand the complexities manufacturers and importers face when entering the Indian market. This guide focuses specifically on the Reamer & its attachments—a Class A medical device used as a hand-held instrument for enlarging bone cavities, including pedicle reamers, reamers for cemented stems, distal reamers for uncemented stems, adaptors, and quick-change tools. These devices fall under the category of General Hospital or Orthopaedic Instruments as per the CDSCO notification 29/Misc./03/2020-DC (193)- Part-3 dated 16.03.2022.

CDSCO Regulatory Framework for Reamer & Its Attachments

The Central Drugs Standard Control Organization (CDSCO) regulates medical devices in India under the Medical Device Rules (MDR) 2017. Since the Reamer & its attachments are classified as Class A (low risk), regulatory oversight is primarily managed by State Licensing Authorities. Compliance ensures patient safety and seamless market access.

Risk Classification and License Requirements for Class A Devices

The Reamer & its attachments fall under Class A (low risk) devices per CDSCO’s risk-based classification system. This classification mandates obtaining an MD5 Manufacturing License (Form MD3) from the State Licensing Authority. For importers, an MD15 Import License is necessary.

You can review the entire medical device classification details here.

Manufacturing License Process (MD5) for Reamer & Its Attachments

The MD5 license application process is comprehensive but straightforward when planned correctly. Here's an overview:

1. Test License (Form MD13): Before applying for MD5, companies must obtain a Test License valid for 6 months to conduct product testing from CDSCO-approved labs.
2. Product Testing: Testing of Reamer & attachments must be completed in government-recognized labs to verify compliance with safety and performance standards.
3. Documentation Preparation: Compile technical and quality documents including Device Master File, Plant Master File, Risk Management File, and QMS documents.
4. Application Submission (Form MD3): Submit the manufacturing license application through the CDSCO MD Online Portal.
5. Audit by Notified Body: An audit of manufacturing premises and documentation by a notified body is mandatory. Refer to the list of notified bodies authorized for Class A device audits.
6. Queries Resolution: Respond promptly to any queries raised by CDSCO or the notified body.
7. License Grant (Form MD5): Upon satisfactory review and audit, the MD5 license is granted.

Manufacturing License Documents Required

For Class A devices like the Reamer & its attachments, prepare the following documents:

• Company Constitution (e.g., MOA, AOA)
• Proof of Ownership or Lease of Manufacturing Premises
• Technical Staff Qualification and Experience Details
• Fire NOC and Pollution Control NOC
• Device Master File (DMF) – Detailed device description, specifications, manufacturing process (See our DMF guide)
• Plant Master File (PMF) – Facility layout, equipment, quality control processes (PMF guide)
• Essential Principles Checklist
• Risk Management File based on ISO 14971 principles (Risk Management insights)
• Test Reports from CDSCO-approved labs (Testing laboratories list)
• Labels and Instructions for Use (IFU)
• Quality Management System (QMS) Documents (ISO 13485:2016 compliance recommended)

Import License Process (MD15) for Reamer & Its Attachments

For manufacturers or importers seeking to bring the Reamer & its attachments into India, an MD15 Import License from the Central Licensing Authority is required. The process includes:

• Preparation of import-specific documents, including the manufacturing license issued by the country of origin
• Submission of application via the CDSCO MD Online Portal
• Resolution of any departmental queries
• Grant of MD15 license

Unlike manufacturing licenses, a test license is not required for imports. However, documentation such as Free Sale Certificate, ISO 13485, CE Certificate, and wholesale license must be submitted.

Read more about the CDSCO Import License process.

Import License Documents Required

• Manufacturing License from country of origin
• Free Sale Certificate
• ISO 13485:2016 Certificate
• CE Certificate or equivalent
• Device Master File
• Plant Master File
• Wholesale Drug License
• Company Constitution documents

Timeline and Processing Duration

Manufacturing License (MD5): Approximately 3 to 4 months total

• Test License (MD13): 1.5 to 2 months
• Product Testing: 1 to 1.5 months
• Audit and License Grant: 1 to 1.5 months

Import License (MD15): Approximately 5 to 6 months

Timely response to CDSCO queries and thorough documentation preparation are critical to avoid delays.

Government Fees and Costs

MD5 Manufacturing License Fees for Class A devices:

• Application fee: ₹5,000
• Per product fee: ₹500

MD15 Import License Fees:

• Class A devices: $1000 per site +$50 per product

These fees are payable through the CDSCO MD Online Portal.

Common Challenges and Solutions

• Incomplete Documentation: Manufacturers often underestimate the detail required in Device Master Files and Risk Management files. Our tip: Use checklists and templates customized for Class A devices to ensure completeness.
• Delayed Product Testing: Testing labs can have backlogs. Plan testing early and choose labs from the official CDSCO list.
• Audit Non-compliance: Audit failures mainly result from poor QMS implementation or facility gaps. Pre-audit mock inspections can identify issues early.
• Query Resolution Delays: Prompt and comprehensive responses to CDSCO queries prevent process stalling.

Expert Consultation and Support

With our extensive experience facilitating over 500 successful CDSCO license approvals, we provide end-to-end support—from documentation to audit preparation and application submission. Our expert team stays updated with the latest regulatory changes, ensuring your Reamer & attachment devices meet all compliance requirements efficiently.

Getting Started with Your CDSCO License Application

1. Assess your product classification and confirm that your Reamer & attachments fall under Class A.
2. Register on the CDSCO MD Online Portal to initiate application submissions.
3. Engage a CDSCO-approved testing laboratory early to schedule product testing.
4. Prepare your Device Master File and Plant Master File with detailed device descriptions, manufacturing process flow, and quality controls.
5. Develop comprehensive Risk Management and QMS documentation aligned with ISO 14971 and ISO 13485 standards.
6. Schedule a pre-audit readiness assessment with your notified body to ensure compliance before formal audit.
7. Submit your Test License application (Form MD13) and await approval.
8. Complete product testing and compile reports.
9. Apply for the MD5 Manufacturing License (Form MD3) once testing is successful.
10. Coordinate with the notified body for the audit and respond promptly to any queries.

Starting early with these practical steps ensures a smooth regulatory journey for your Reamer & its attachments, enabling you to capitalize on the growing Indian orthopaedic instrument market with confidence and compliance.

For tailored assistance, reach out to our regulatory experts who will guide you through every step, ensuring your CDSCO license application is successful and timely.