CDSCO License for Dental bone particle collector
Medical Device Information
Intended Use
A device used to collect bone debris generated by drilling, etc. during oral surgery.
Introduction to Dental Bone Particle Collector and Its Regulatory Importance
A Dental Bone Particle Collector is a specialized medical device designed to efficiently collect bone debris generated during oral surgical procedures such as drilling. This device plays a critical role in maintaining surgical site hygiene and potentially aids in autologous bone grafting. Given its direct use in invasive dental surgery, regulatory oversight by the Central Drugs Standard Control Organization (CDSCO) is essential to ensure safety, quality, and compliance with Indian medical device regulations.
At our consultancy, with over 25 years of experience and having assisted 500+ manufacturers and importers, we understand the nuances of navigating the CDSCO licensing process for dental devices, including the Dental Bone Particle Collector, classified as a Class B medical device under the CDSCO classification system.
CDSCO Regulatory Framework for Dental Bone Particle Collector
The Dental Bone Particle Collector falls under the dental device category notified by CDSCO under notification number 29/Misc./03/2020-DC (140) Part-5, dated 10.10.2022. As a Class B device, it is subject to moderate risk controls and requires a state-level manufacturing license (MD5) before being marketed or imported in India.
The regulatory framework mandates compliance with the Medical Device Rules 2017, including adherence to quality management systems, product testing, and audit requirements before license issuance.
Risk Classification and License Requirements
As per CDSCO regulations, medical devices are classified into four risk classes: A, B, C, and D. The Dental Bone Particle Collector is classified as Class B due to its invasive nature but relatively low risk compared to implantable or life-supporting devices.
Key License Requirement:
- Manufacturing License: MD5 (Application Form MD3) granted by the State Licensing Authority.
- Import License: If importing, an MD15 license from the Central Licensing Authority is required.
The MD5 license process primarily involves obtaining a test license (MD13), product testing, audit by an approved notified body, and final license issuance.
Manufacturing License Process (MD5) for Dental Bone Particle Collector
The MD5 license process for Class B medical devices like the Dental Bone Particle Collector involves the following key steps:
Apply for a Test License (Form MD13): This initial step allows the manufacturer to commence product testing. It typically takes 1.5 to 2 months for processing.
Product Testing: Testing must be conducted at CDSCO-approved laboratories to validate safety and performance. Refer to the list of CDSCO testing laboratories for approved centers.
Document Preparation: Prepare comprehensive documentation including Device Master File, Plant Master File, Risk Management File, Essential Principles Checklist, and Quality Management System (QMS) documents.
Application Submission for MD5 License (Form MD3): Submit the application via the CDSCO MD Online Portal along with all supporting documents and test reports.
Audit by Notified Body: A mandatory audit is conducted by a notified body from the CDSCO Notified Bodies List to verify compliance.
Queries Resolution: Address any queries or deficiencies raised by the department or notified body promptly.
License Grant: Upon satisfactory compliance, the MD5 manufacturing license is granted.
Manufacturing License Documents Required for Dental Bone Particle Collector
To ensure a smooth application process, the following documents must be meticulously prepared and submitted:
- Company Constitution Documents: Incorporation certificate, partnership deed, or equivalent.
- Proof of Ownership or Lease of Manufacturing Premises: Rent agreement or ownership proof.
- Technical Staff Details: Qualification and experience certificates of key technical personnel.
- Fire NOC and Pollution Control NOC: Valid certificates obtained from respective authorities.
- Device Master File (DMF): Detailed product description, specifications, manufacturing process, and controls. Our Device Master File guide provides an in-depth overview.
- Plant Master File (PMF): Details of manufacturing facility including infrastructure and equipment. See our Plant Master File guide for assistance.
- Essential Principles Checklist: Compliance matrix with Indian and international standards.
- Risk Management File: Hazard analysis, risk evaluation, and mitigation measures per ISO 14971 principles.
- Test Reports: From CDSCO-approved laboratories validating device safety and performance.
- Labels and Instructions for Use (IFU): Drafts compliant with regulatory requirements.
- Quality Management System (QMS) Documents: ISO 13485 certification and supporting records.
Import License Process (MD15) for Dental Bone Particle Collector
If you plan to import the Dental Bone Particle Collector into India, the MD15 import license is mandatory. The process is centralized under CDSCO and includes these steps:
Comprehensive Document Preparation: Include manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016 certification, CE certificate if applicable, Device Master and Plant Master Files, and wholesale license.
Application Submission: File the application using Form MD14 on the CDSCO MD Online Portal.
Queries Resolution: Address any clarifications raised by CDSCO authorities.
License Issuance: Upon satisfactory review, the import license MD15 is granted.
The overall timeline for MD15 license issuance is approximately 5 to 6 months.
Import License Documents Required
- 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 in India
- Company Constitution Documents
Timeline and Processing Duration
| License Type | Process Steps | Estimated Duration |
|---|---|---|
| MD5 License (Class B) | Test License, Testing, Audit, Queries, Grant | 3 - 4 months |
| MD15 Import License | Document Preparation, Application, Queries, Grant | 5 - 6 months |
The test license (MD13) alone takes about 1.5 to 2 months, followed by product testing and audit procedures. Timely submission of complete and accurate documents can significantly reduce delays.
Government Fees and Costs
For the Dental Bone Particle Collector (Class B), the fee structure is as follows:
MD5 Manufacturing License:
- Application Fee: Rs. 5,000
- Per Product Fee: Rs. 500
MD15 Import License:
- Site Fee: $2,000 USD
- Per Product Fee: $1,000 USD
Additional costs include testing charges at approved labs, audit fees charged by notified bodies, and potential consultancy fees.
Common Challenges and Solutions
Challenge 1: Delays due to incomplete documentation
- Solution: Conduct a thorough gap analysis and prepare documentation with expert guidance upfront.
Challenge 2: Difficulty in obtaining timely product testing slots
- Solution: Schedule testing well in advance and select laboratories with optimal availability from the CDSCO testing laboratories list.
Challenge 3: Audit non-compliance issues
- Solution: Prepare for audits by pre-assessing your QMS and manufacturing processes. Engage notified bodies early and clarify audit scope.
Challenge 4: Query resolution delays
- Solution: Assign dedicated regulatory personnel to respond promptly with clear, evidence-backed replies.
Expert Consultation and Support
With 25+ years of hands-on experience and over 500 successful client engagements, we offer end-to-end support for your Dental Bone Particle Collector licensing journey. From documentation preparation, liaison with CDSCO, audit facilitation, to post-approval compliance, our expert team ensures a hassle-free experience.
Leverage our proven methodologies and insider knowledge to avoid common pitfalls and accelerate your time-to-market.
Getting Started with Your CDSCO License Application
To initiate your CDSCO licensing process for the Dental Bone Particle Collector:
- Register on the CDSCO MD Online Portal.
- Apply for the Test License (Form MD13) to begin product testing.
- Engage with a notified body early to schedule your audit.
- Prepare and organize all required documents as per the checklist above.
- Plan your timelines realistically to accommodate testing and audit durations.
Our team can assist you in preparing a tailored project plan, ensuring all regulatory submissions are precise, timely, and compliant. Contact us today to discuss your unique needs and streamline your entry into the Indian dental device market.
