CDSCO License for Plaster Instruments/Saw

Comprehensive Guide to CDSCO Licensing for Plaster Instruments/Saw (Class A Medical Devices)

Plaster Instruments and Saws, including plaster saw (single & heavy-duty types), plaster benders, spreaders, and shears, are essential tools in orthopaedic and general hospital settings. Classified as Class A under the CDSCO framework, these devices are considered low risk but still require strict regulatory compliance before entering the Indian market. With over 25 years of expertise and having supported 500+ companies, we provide detailed guidance to help you navigate the licensing process efficiently and confidently.

CDSCO Regulatory Framework for Plaster Instruments/Saw

The Central Drugs Standard Control Organization (CDSCO) regulates medical devices in India under the Medical Device Rules, 2017. Your plaster instruments fall under the category of "General Hospital or Orthopaedic Instruments" as notified by the Government of India (Notification No.: 29/Misc./03/2020-DC (193)- Part-3 dated 16.03.2022). This ensures that your products comply with safety, quality, and performance standards before market access.

As a Class A device, the regulatory responsibility lies with the State Licensing Authority, and licensing is granted via the MD5 license pathway using Application Form MD3.

Risk Classification and License Requirements for Plaster Instruments/Saw

Under Medical Device Rules, 2017, plaster instruments are classified as Class A (low risk) devices. The classification impacts:

• License type: MD5 Manufacturing License
• Licensing Authority: State Licensing Authority
• Application Form: MD3

Class A devices require a test license (Form MD13) before the full license application. Testing must be conducted at government-approved laboratories.

For more on classification, refer to our detailed Medical Device Classification guide.

Manufacturing License Process (MD5) for Plaster Instruments/Saw

The MD5 license process involves several key steps:

1. Apply for Test License (Form MD13): This initial license allows you to manufacture samples for testing.
2. Product Testing: Send your instruments to government-approved labs for quality and safety testing.
3. Document Preparation: Compile all required technical and quality documents.
4. Submit MD5 Application (Form MD3): Apply through the CDSCO MD Online Portal.
5. Audit by Notified Body: An audit ensures compliance with Good Manufacturing Practices (GMP).
6. Query Resolution: Address any clarifications or additional information requests.
7. License Grant: Upon satisfaction, the State Licensing Authority issues the MD5 license.

This process typically takes 3 to 4 months from test license application to final license grant.

Manufacturing License Documents Required for Plaster Instruments/Saw

Be prepared with the following documents to ensure smooth processing:

• Company Constitution (e.g., Partnership Deed, Incorporation Certificate)
• Proof of Ownership or Lease of Manufacturing Premises
• Details and Qualification Documents of Technical Staff
• Fire NOC and Pollution Control NOC
• Device Master File (DMF) detailing design, manufacturing process, specifications, and validation. Check our Device Master File guide for preparation tips.
• Plant Master File (PMF) describing manufacturing facilities and quality systems. Refer to our Plant Master File guide.
• Essential Principles Checklist demonstrating conformity with safety and performance requirements
• Risk Management File showing identification and mitigation of potential hazards. Learn more about Risk Management implementation.
• Test Reports from CDSCO-approved laboratories
• Product Labels and Instructions for Use (IFU)
• Quality Management System (QMS) Documents, ideally ISO 13485 compliant

Import License Process (MD15) for Plaster Instruments/Saw

If you are an importer rather than a manufacturer, the MD15 license is required. This license is granted by the Central Licensing Authority and takes approximately 5 to 6 months.

Key steps include:

• Preparation of comprehensive documentation including Manufacturing License, Free Sale Certificate from the country of origin, ISO 13485:2016 certification, CE Certificate, Device Master File, Plant Master File, and Wholesale License.
• Application submission via the CDSCO MD Online Portal.
• Departmental review and query resolution.
• License issuance upon satisfactory compliance.

Costs vary depending on device class; for Class A devices, fees are relatively nominal compared to higher classes.

For detailed insights, see our Import License Guide.

Import License Documents Required for Plaster Instruments/Saw

• Valid Manufacturing License of the product
• Free Sale Certificate from the exporting country
• ISO 13485:2016 Certification
• CE Certificate or equivalent
• Device Master File
• Plant Master File
• Wholesale License
• Company Constitution

Timeline and Processing Duration

For import licenses (MD15), the total processing time is approximately 5 to 6 months due to central-level scrutiny.

Government Fees and Costs

For Class A plaster instruments, the fees are as follows:

• Test License (Form MD13): No separate fee but mandatory pre-requisite
• MD5 Manufacturing License: Rs. 5000 per application + Rs. 500 per product

Additional costs include testing laboratory fees, audit fees charged by notified bodies, and costs related to document preparation and consultancy if engaged.

Common Challenges and Solutions

• Delay in Testing: Government-approved labs may have backlogs. Plan testing early and consider alternate notified labs from the Testing Laboratories list.
• Document Gaps: Missing or incomplete Device Master Files and Risk Management documents often delay approvals. Utilize templates and expert reviews.
• Audit Non-compliance: Insufficient QMS or manufacturing facility readiness can lead to negative audit outcomes. Conduct internal audits beforehand.
• Query Resolution: Delayed responses to CDSCO queries can extend timelines. Assign dedicated teams to handle these promptly.

Expert Consultation and Support

With a track record of assisting over 500 companies, we specialize in:

• End-to-end CDSCO licensing support tailored to Class A devices like plaster saws
• Preparation of Device and Plant Master Files aligned with regulatory expectations
• Coordination with notified bodies for audits and laboratories for product testing
• Proactive handling of queries and compliance gaps
• Strategic planning to minimize approval timelines and costs

Our expertise ensures your licensing journey is smooth, efficient, and compliant.

Getting Started with Your CDSCO License Application

1. Assess your product classification to confirm Class A status (plaster instruments/saw).
2. Prepare your manufacturing facility in line with GMP and ISO 13485 standards.
3. Compile all necessary documentation: Begin drafting your Device Master File, Plant Master File, Risk Management File, and Essential Principles Checklist.
4. Apply for the Test License (Form MD13) through the CDSCO MD Online Portal.
5. Plan product testing with government-approved laboratories promptly after receiving the test license.
6. Schedule your notified body audit early by checking the list of notified bodies.
7. Submit your MD5 application (Form MD3) as soon as test reports and audit readiness are confirmed.
8. Respond timely to any queries from CDSCO or notified bodies.

By following these detailed steps, manufacturers and importers can confidently enter the Indian market with compliant plaster instruments and saws.

For personalized assistance and regulatory consultancy, feel free to reach out to our experts who have successfully navigated these processes for hundreds of clients.

Empower your medical device business with trusted CDSCO licensing guidance tailored specifically for plaster instruments and saws. Start your application today and bring quality orthopaedic instruments to healthcare providers across India.