CDSCO License for Powered general- purpose operation  table

Introduction to Powered General-Purpose Operation Tables and Regulatory Importance

Powered general-purpose operation tables are essential medical devices designed to support surgical procedures for various parts of the body. These electrically line or battery-operated mobile surgical tables improve operational efficiency and patient comfort in operation theatres. Given their critical role in surgeries, regulatory compliance under the Central Drugs Standard Control Organization (CDSCO) is mandatory for manufacturers and importers in India. Navigating CDSCO licensing ensures your device meets safety, quality, and performance standards, building trust with healthcare providers and patients.

CDSCO Regulatory Framework for Powered General-Purpose Operation Tables

Our extensive experience advising over 500 companies reveals that powered operation tables fall under Class A devices as per CDSCO’s risk classification. This means they are considered low-risk and regulated primarily by State Licensing Authorities through the MD5 license pathway. Compliance involves multiple stages including testing, documentation, audits, and timely submissions via the CDSCO MD Online Portal.

Risk Classification and License Requirements for Class A Medical Devices

The powered general-purpose operation table is classified as Class A under the CDSCO medical device classification system due to its low-risk profile. Class A devices require an MD5 manufacturing license, governed by the State Licensing Authority. The entire process typically spans 3 to 4 months. It starts with obtaining a test license (Form MD13), followed by product testing in government-approved labs, documentation, audit by a notified body, and finally license issuance on Form MD5.

For detailed classification, manufacturers can refer to the Medical Device Classification guide.

Manufacturing License Process (MD5) for Powered General-Purpose Operation Tables

1. Test License Application (Form MD13): Initiate licensing by applying for a test license that allows sample testing. This step takes approximately 1.5 to 2 months.
2. Product Testing: Get your powered operation tables tested at CDSCO-recognized laboratories to verify compliance. A list of approved Testing Laboratories is available.
3. Document Preparation: Prepare comprehensive documentation including Device Master File, Plant Master File, Essential Principles Checklist, Risk Management File, and QMS documents.
4. License Application (Form MD3): Submit the manufacturing license application for the MD5 license.
5. Audit by Notified Body: A mandatory audit from a notified body listed here evaluates your manufacturing site’s compliance.
6. Query Resolution: Address any observations or queries raised by authorities or auditors.
7. License Grant: Upon successful verification, the MD5 license is granted on Form MD5.

Manufacturing License Documents Required for MD5 Licensing

For your powered general-purpose operation table, ensure you have the following documentation ready:

• Company Constitution and Legal Entity Proof
• Proof of Ownership or Lease of Manufacturing Premises
• Technical Staff Qualification Certificates and Details
• Fire and Pollution NOCs
• Device Master File: Detailed design and manufacturing processes (Device Master File Guide)
• Plant Master File: Details of manufacturing facilities (Plant Master File Guide)
• Essential Principles Checklist confirming compliance with Indian regulations
• Risk Management File adhering to ISO 14971 principles (Risk Management Guide)
• Test Reports from government-approved laboratories
• Product Labels and Instructions for Use (IFU)
• Quality Management System Documentation, preferably ISO 13485 certified

Import License Process (MD15) for Powered General-Purpose Operation Tables

While this content focuses on manufacturing, importers of powered general-purpose operation tables must apply for an MD15 import license with the Central Licensing Authority. This process is lengthier, typically taking 5 to 6 months, and requires additional documentation such as Free Sale Certificate, CE Certificate, and Wholesale License.

For a detailed import license procedure, refer to our Import License Guide.

Import License Documents Required for MD15 Licensing

• Valid Manufacturing License from the Country of Origin
• Free Sale Certificate
• ISO 13485:2016 Certificate
• CE Certificate or Equivalent
• Device Master File and Plant Master File
• Wholesale License in India
• Company Constitution and Legal Documents

Timeline and Processing Duration for MD5 Licensing

Based on our hands-on experience, the timeline for a powered general-purpose operation table Class A device is as follows:

• Test License (MD13): 1.5 to 2 months
• Product Testing: 3 to 4 weeks
• Document Preparation: Concurrent with testing
• Audit by Notified Body: Scheduled within 1 month post-document submission
• Query Resolution: 2 to 4 weeks depending on the complexity
• Final License Grant: Within 3 to 4 months from initial application

Proper planning and early submission of complete documentation can prevent delays.

Government Fees and Costs for Class A MD5 License

• Test License (MD13) Fees: Included in overall process
• MD5 License Application Fee: Rs 5,000 per application
• Product Fee: Rs 500 per product variant
• Additional costs include audit fees charged by notified bodies (varies)

These fees are reasonable compared to higher risk class devices and reflect the streamlined process for Class A devices.

Common Challenges and Solutions in Licensing Powered General-Purpose Operation Tables

• Incomplete Documentation: Missing critical documents like Device Master File can stall applications. Solution: Use checklists and expert consultants.
• Delay in Product Testing: Limited slots in government labs may cause delays. Solution: Schedule testing early and explore alternate approved labs.
• Audit Non-Compliance: Manufacturing site may not meet notified body standards. Solution: Conduct internal pre-audits and implement corrective actions.
• Query Management: Delayed responses to CDSCO queries prolong timelines. Solution: Assign dedicated regulatory personnel for timely communication.

Expert Consultation and Support

With over 25 years of experience and assisting 500+ companies, our team provides end-to-end support including documentation preparation, audit readiness, and liaison with CDSCO authorities. We help navigate complexities efficiently, ensuring timely approvals.

Getting Started with Your CDSCO License Application for Powered General-Purpose Operation Tables

1. Assess Your Device Classification: Confirm your device as Class A.
2. Gather Preliminary Documents: Begin compiling company and technical documents.
3. Apply for Test License: Submit Form MD13 through the CDSCO MD Online Portal.
4. Plan Product Testing: Coordinate with government-approved testing labs.
5. Prepare Device and Plant Master Files: Utilize our comprehensive guides to ensure compliance.
6. Schedule Notified Body Audit: Select a notified body from the official list and prepare your facility.
7. Submit Manufacturing License Application (Form MD3): Post successful testing and audit.

Taking these actionable steps early will streamline your path to obtaining the MD5 license for your powered general-purpose operation table, enabling your entry into the Indian medical device market with confidence and compliance.