CDSCO License for Powered Surgical Drill Hand piece for Dental applications

Comprehensive Guide to CDSCO Licensing for Powered Surgical Drill Hand Pieces in Dental Applications

As a trusted regulatory consultancy with over 25 years of experience and having successfully supported 500+ companies, we understand the nuances of obtaining a CDSCO license for medical devices like the Powered Surgical Drill Hand piece used in dental procedures. This device, classified as Class B under CDSCO regulations, requires a meticulous approach to comply with Indian regulatory standards. This guide provides practical, actionable insights for manufacturers and importers aiming to enter the Indian market with this specific device.

Understanding the Device and Regulatory Importance

The Powered Surgical Drill Hand piece is a critical dental device designed to facilitate a variety of operations such as cutting, inserting, and trimming, by connecting different attachments. Given its direct contact with patients during invasive procedures, regulatory compliance is essential to ensure safety, efficacy, and quality. The notification governing this device is 29/Misc./03/2020-DC (140) Part-5, dated 10.10.2022, which places it firmly under Class B risk category.

CDSCO Regulatory Framework for Powered Surgical Drill Hand Pieces (Class B)

In India, the Central Drugs Standard Control Organization (CDSCO) regulates medical devices under the Medical Device Rules, 2017. Class B devices fall under the medium risk category, requiring manufacturers to obtain a manufacturing license known as the MD5 license, granted by the State Licensing Authority. This ensures that the device meets essential principles of safety and performance, supported by rigorous documentation, testing, and audit processes.

Risk Classification and License Requirements

The Powered Surgical Drill Hand piece for dental use is classified as Class B, as per the notification dated 10.10.2022. This classification triggers specific licensing requirements:

• License Type: MD5 (Manufacturing License for Class A and B Devices)
• Regulatory Authority: State Licensing Authority
• Application Form: MD3
• Process Duration: Approximately 3-4 months
• Fees: Rs. 5,000 per application + Rs. 500 per product

For a detailed understanding of medical device classification, manufacturers can refer to our Medical Device Classification guide.

Manufacturing License Process (MD5) for Class B Devices

The MD5 licensing process involves several crucial steps:

1. Test License Application (Form MD13): Before manufacturing, you must obtain a test license, which takes about 1.5 to 2 months.
2. Product Testing: Conduct product tests at CDSCO-approved laboratories to verify compliance with applicable standards. You can find a list of government-approved testing laboratories here.
3. Documentation Preparation: Assemble the required documents, including Device Master File, Plant Master File, Essential Principles Checklist, and Risk Management File.
4. License Application (Form MD3): Submit the manufacturing license application on the CDSCO MD Online Portal.
5. Audit by Notified Body: A notified body conducts an on-site audit to verify compliance. Refer to the list of notified bodies for selection.
6. Query Resolution: Respond promptly to any queries or observations raised by the licensing authority or the notified body.
7. Grant of License (Form MD5): Upon satisfactory compliance, the license is granted.

Manufacturing License Documents Required

For the Powered Surgical Drill Hand piece, the following documents are essential:

• Company constitution and registration proof
• Proof of ownership or lease of manufacturing premises
• Technical staff qualifications and experience documentation
• Fire and Pollution NOCs
• Device Master File (DMF): Detailed design, manufacturing, and performance information. Our Device Master File guide can help streamline this.
• Plant Master File (PMF): Overview of manufacturing facilities and quality management systems. See our Plant Master File guide.
• Essential Principles Compliance Checklist
• Risk Management File: Demonstrating risk analysis and mitigation strategies. Learn more in our Risk Management guide.
• Test Reports from CDSCO-approved labs
• Device labels and Instructions for Use (IFU)
• Quality Management System (QMS) documents, preferably ISO 13485 certified

Import License Process (MD15) for Powered Surgical Drill Hand pieces

If the device is to be imported, an MD15 license from the Central Licensing Authority is mandatory. The process typically takes 5-6 months and requires:

• Manufacturing license from the country of origin
• Free Sale Certificate
• ISO 13485:2016 certification
• CE Certificate (if applicable)
• Device Master File and Plant Master File
• Wholesale license
• Company constitution

The application is made on the CDSCO MD Online Portal using Form MD14. Fees vary depending on device class.

For detailed guidance, our Import License guide provides step-by-step instructions.

Timeline and Processing Duration

Government Fees and Costs

• Application Fee: Rs. 5,000 per application
• Product Fee: Rs. 500 per product
• Additional costs include testing fees at government-approved labs (varies by test scope) and audit fees payable to notified bodies.

Common Challenges and Practical Solutions

Challenge 1: Documentation Gaps Many manufacturers face delays due to incomplete or inconsistent documentation. Preparing a comprehensive Device and Plant Master File early in the process helps avoid this pitfall.

Solution: Utilize our detailed guides on Device Master File and Plant Master File preparation to ensure completeness.

Challenge 2: Delayed Product Testing Limited availability at approved testing labs can slow down the timeline.

Solution: Schedule testing appointments well in advance and consider multiple accredited labs listed on the CDSCO portal to expedite this step.

Challenge 3: Audit Non-Compliance Non-conformities during the notified body audit can cause significant delays.

Solution: Conduct internal pre-audits with experienced consultants to identify and rectify gaps before the official audit.

Expert Consultation and Support

Navigating the CDSCO licensing process for a Powered Surgical Drill Hand piece can be complex but manageable with expert assistance. Our team offers:

• Comprehensive regulatory strategy tailored to device specifics
• End-to-end documentation preparation
• Liaison with notified bodies and CDSCO officials
• Pre-audit readiness assessments
• Training for your technical and quality teams

Getting Started with Your CDSCO License Application

To initiate your MD5 license application for the Powered Surgical Drill Hand piece:

1. Register on the CDSCO MD Online Portal to create your account.
2. Apply for the Test License (Form MD13) immediately since it precedes manufacturing.
3. Prepare all required documentation in parallel, especially the Device and Plant Master Files.
4. Engage an accredited testing laboratory early to plan product testing.
5. Schedule notified body audit after test reports are in hand.
6. Maintain proactive communication with regulatory authorities to swiftly address queries.

By following these precise steps and leveraging our extensive experience, manufacturers and importers can efficiently secure their CDSCO license and successfully launch the Powered Surgical Drill Hand piece in the Indian market.

For personalized support or further queries, feel free to contact our expert team and access our detailed guides linked throughout this page.