CDSCO License for Periostic elevator

Introduction to Periostic Elevator and Its Regulatory Importance

The Periostic elevator is a crucial sterile, single-use dental instrument designed to lift, separate, or displace teeth and soft tissues during dental procedures. Classified under General Hospital or Orthopaedic Instruments, it facilitates precise and minimally invasive dental surgeries. Given its direct contact with patients and sterile nature, regulatory compliance is paramount to ensure patient safety and market access in India.

Manufacturers and importers must secure a valid CDSCO license before marketing the Periostic elevator in India. This regulatory approval confirms adherence to quality, safety, and performance standards mandated by the Central Drugs Standard Control Organization (CDSCO).

CDSCO Regulatory Framework for Periostic Elevator

According to the CDSCO notification 29/Misc./03/2020-DC (193)- Part-3 dated 16.03.2022, the Periostic elevator is classified as a Class A medical device due to its low risk profile. This classification simplifies the regulatory pathway but still requires strict compliance with CDSCO guidelines, including documentation, testing, and audits.

Risk Classification and License Requirements

The Periostic elevator falls under Class A (low risk) devices, governed by the State Licensing Authority via the MD5 license process. This license is mandatory for manufacturing and marketing this device in India.

Manufacturing License Process (MD5)

The MD5 licensing process involves several critical steps:

1. Test License (Form MD13): Apply first for a test license to conduct product testing. This stage takes approximately 1.5 to 2 months.
2. Product Testing: Get the Periostic elevator tested at a CDSCO-approved laboratory to verify compliance with Indian standards.
3. Document Preparation: Compile all required documents, including technical, quality, and compliance files.
4. Application Submission: Submit the manufacturing license application using Form MD3 through the CDSCO MD Online Portal.
5. Audit by Notified Body: A third-party notified body conducts an audit of your manufacturing site and documentation.
6. Queries Resolution: Address any queries from the CDSCO or notified body promptly.
7. License Grant: Upon satisfactory review, the State Licensing Authority issues the MD5 license (Form MD5).

Manufacturing License Documents Required

For a Class A Periostic elevator, prepare the following documents meticulously:

• Company Constitution and Incorporation Certificates
• Proof of Ownership or Lease Agreement of Manufacturing Premises
• Details and Qualifications of Technical Staff
• Fire NOC and Pollution Control NOC
• Device Master File (DMF): Detailed design and manufacturing process description (Device Master File Guide)
• Plant Master File (PMF): Documentation of manufacturing environment and quality systems (Plant Master File Guide)
• Essential Principles Compliance Checklist
• Risk Management File (Risk Management Guide)
• Test Reports from CDSCO-approved labs (Testing Laboratories)
• Labels, Instructions for Use (IFU)
• Quality Management System (QMS) Documents (e.g., ISO 13485:2016 certificates)

Import License Process (MD15) – When Applicable

If you intend to import the Periostic elevator rather than manufacture it locally, you will require an MD15 import license granted by the Central Licensing Authority. The process takes around 5-6 months and requires:

• Valid Manufacturing License of the foreign manufacturer
• Free Sale Certificate from the country of origin
• ISO 13485:2016 and CE Certificate
• Device and Plant Master Files
• Wholesale Drug License in India

Application is submitted via the CDSCO MD Online Portal, using Form MD14.

Timeline and Processing Duration

Total Estimated Time: Approximately 3-4 months for a smooth and compliant MD5 license grant.

Government Fees and Costs

• Application Fee: Rs 5000 per MD5 license application
• Product Fee: Rs 500 per product

Other costs to budget for include notified body audit fees, product testing charges at CDSCO-approved labs, and documentation preparation support if outsourced.

Common Challenges and Solutions

Challenge 1: Delays in product testing due to limited slots at government-approved labs.

Solution: Schedule your testing well in advance and consider labs from the CDSCO Testing Laboratories list.

Challenge 2: Incomplete documentation leading to queries and rejections.

Solution: Use comprehensive checklists and consult expert regulatory consultants to prepare your Device Master File and Plant Master File accurately.

Challenge 3: Audit non-compliance issues during notified body inspection.

Solution: Conduct internal audits and mock inspections before the notified body visit. Refer to the list of notified bodies to select a competent auditor.

Expert Consultation and Support

With over 25 years of experience and having assisted 500+ companies in securing CDSCO licenses, we provide end-to-end support including:

• Gap analysis of your current compliance status
• Preparation and review of Device and Plant Master Files
• Coordination with notified bodies and testing laboratories
• Stepwise application filing and query resolution

Our proven approach minimizes delays and maximizes approval chances.

Getting Started with Your CDSCO License Application

To initiate your manufacturing license process for the Periostic elevator:

1. Register your company on the CDSCO MD Online Portal.
2. Apply for the Test License (Form MD13), ensuring you have identified a CDSCO-approved testing laboratory.
3. Start compiling your Device Master File and Plant Master File using our detailed guides.
4. Schedule your product testing and prepare for the notified body audit.
5. Submit the manufacturing license application (Form MD3) after successful test results.

Taking these practical steps early and with expert guidance will set you on a clear path to compliance and market access.

Embark on your CDSCO licensing journey today with confidence and clarity.