CDSCO License for Dental dressing forceps, reusable
Medical Device Information
Important Notice for Class A Devices
Class A Non-sterile Non Measuring devices are exempt from MD5 and MD15 licenses. Only CDSCO registration is required as per GSR 777(E).
Intended Use
A hand-held manual dental instrument designed for grasping and holding a dental dressing during its application to a patient's oral cavity.
Comprehensive Guide to CDSCO Licensing for Reusable Dental Dressing Forceps (Class A Medical Device)
As seasoned regulatory consultants with over 25 years of experience and having successfully supported 500+ medical device companies, we understand the nuances and challenges manufacturers and importers face in securing CDSCO licenses. This guide focuses on the dental dressing forceps, reusable, a Class A medical device, providing detailed insights into the CDSCO licensing process, timelines, documentation, costs, and practical tips to help you efficiently navigate the regulatory pathway.
Introduction to Dental Dressing Forceps and Regulatory Importance
Dental dressing forceps are critical hand-held manual instruments used by dental professionals to grasp and place dental dressings accurately within a patient's oral cavity. Given their direct contact with patients, regulatory oversight ensures these devices meet safety and quality standards to protect public health.
In India, the Central Drugs Standard Control Organization (CDSCO) regulates medical devices, including dental instruments, under the Medical Device Rules, 2017. Compliance with these regulations and obtaining the appropriate license is mandatory before you can manufacture or market these forceps in India.
CDSCO Regulatory Framework for Dental Dressing Forceps
The CDSCO Medical Device Rules, 2017 classify medical devices based on risk. Dental dressing forceps, reusable, fall under the Class A (low risk) category as notified under Notification No. 29/Misc./03/2020-DC (140) Part-5 dated 10.10.2022.
Manufacturers of Class A devices require a Manufacturing License (MD5) issued by the State Licensing Authority. The process involves obtaining a test license, product testing, audit by a notified body, and final license issuance.
Risk Classification and License Requirements for Dental Dressing Forceps
- Risk Class: A (Low Risk)
- License Type: MD5 (Manufacturing License for Class A & B devices)
- Applicable Authority: State Licensing Authority
- Application Form: MD3 for final license, MD13 for test license
Refer to the detailed medical device classification guide to understand classification nuances.
Manufacturing License Process (MD5) for Reusable Dental Dressing Forceps
The MD5 license process typically takes 3 to 4 months and involves the following key steps:
Application for Test License (Form MD13):
- Submit initial application to the State Licensing Authority to obtain the test license.
- Duration: Approximately 1.5 to 2 months.
Product Testing:
- Get your dental dressing forceps tested at a CDSCO-approved government testing laboratory.
- Refer to the list of testing laboratories.
Document Preparation:
- Prepare comprehensive technical documentation including Device Master File (DMF), Plant Master File (PMF), risk management files, and quality management system documentation.
- Our thorough Device Master File guide can assist you in compiling these essential documents.
Submission of Manufacturing License Application (Form MD3):
- Apply via the CDSCO MD Online Portal.
Audit by Notified Body:
- State Licensing Authority will coordinate an audit by a notified body from the official notified bodies list.
Resolution of Queries:
- Address any clarifications or deficiencies raised by the authorities or auditors promptly.
Grant of MD5 License (Form MD5):
- Upon satisfaction, the State Licensing Authority issues the manufacturing license.
Manufacturing License Documents Required for Dental Dressing Forceps
- Company Constitution (e.g., Certificate of Incorporation)
- Proof of ownership/lease of manufacturing premises
- Qualification and experience details of technical staff
- Fire NOC and Pollution Control Board NOC
- Device Master File (DMF) detailing design, materials, and manufacturing process
- Plant Master File (PMF) showing facility layout and equipment
- Essential Principles Checklist confirming compliance with medical device standards
- Risk Management File addressing device-specific risks (risk management resource)
- Product Test Reports from government-approved labs
- Labels and Instructions for Use (IFU)
- Quality Management System (QMS) documentation (ISO 13485 preferred)
Import License Process (MD15) for Dental Dressing Forceps
As a Class A device, if you are importing dental dressing forceps into India, you will require an Import License (MD15) issued by the Central Licensing Authority. The process takes approximately 5 to 6 months and involves:
- Comprehensive document preparation including Free Sale Certificate, ISO 13485 certification, CE certificate (if applicable), Device Master and Plant Master Files, and Wholesale License.
- Submission of application via the CDSCO MD Online Portal.
- Resolution of departmental queries.
For a detailed import license process overview, refer to our Import License Guide.
Import License Documents Required
- Valid Manufacturing License from country of origin
- Free Sale Certificate
- ISO 13485:2016 certificate
- CE Certificate (if applicable)
- Device Master File and Plant Master File
- Wholesale Drug License
- Company Constitution documents
Timeline and Processing Duration
| License Type | Process Duration |
|---|---|
| Test License (MD13) | 1.5 to 2 months |
| Product Testing | 2 to 4 weeks (depends on lab) |
| MD5 License (MD3) | 1.5 to 2 months after audit |
Total estimated time: 3 to 4 months.
Government Fees and Costs
- Application Fee for MD5 License: INR 5,000 per application
- Product Fee: INR 500 per product
These fees are payable online during application submission through the CDSCO portal.
Common Challenges and Practical Solutions
Challenge 1: Delays in product testing
- Solution: Early engagement with notified testing laboratories and pre-booking test slots helps avoid bottlenecks.
Challenge 2: Audit non-compliance
- Solution: Conduct internal mock audits using the Plant Master File guide to ensure your facility and documentation meet notified body expectations.
Challenge 3: Incomplete documentation
- Solution: Use comprehensive checklists and templates for Device Master File and risk management to ensure no gaps.
Expert Consultation and Support
With our extensive experience supporting over 500 clients through CDSCO licensing, we offer end-to-end consulting services—from documentation preparation and audit readiness to liaison with regulatory authorities. Our practical approach ensures your dental dressing forceps licensing proceeds smoothly and on schedule.
Getting Started with Your CDSCO License Application
- Register on the CDSCO MD Online Portal.
- Apply for the test license (Form MD13) promptly to initiate the process.
- Engage a notified body early for audit scheduling.
- Prepare your Device Master File and Plant Master File using expert resources.
- Coordinate testing at approved government labs without delay.
- Maintain thorough records and respond quickly to any queries.
Starting early and following a structured approach significantly reduces processing time and increases your chances of license approval for your reusable dental dressing forceps.
For personalized assistance, detailed document templates, and audit preparation strategies, contact our regulatory experts today and leverage our 25+ years of industry expertise to secure your CDSCO license efficiently.
