CDSCO License for Surgical Probe

Comprehensive Guide to CDSCO Licensing for Surgical Probe (Class A Medical Device)

Surgical probes, including curved/straight probes, thoracic probes, and Depuy curved probes, are integral tools in general hospital and orthopaedic procedures. As Class A devices under the Indian medical device regulatory framework, these low-risk instruments require a carefully managed licensing process to ensure market compliance and patient safety. With over 25 years of experience assisting 500+ companies in obtaining CDSCO licenses, we provide a detailed, practical roadmap for manufacturers and importers aiming to enter the Indian market with Surgical Probes.

CDSCO Regulatory Framework for Surgical Probes

The Central Drugs Standard Control Organization (CDSCO) regulates medical devices under the Medical Device Rules, 2017, as amended. Surgical probes fall under the notified category of General Hospital or Orthopaedic Instruments, referenced in the notification 29/Misc./03/2020-DC (193)- Part-3 dated 16.03.2022. This categorization defines the risk classification and licensing pathway.

Being classified as Class A devices—a low-risk group—the regulatory oversight is managed primarily at the state level through the issuance of the MD5 Manufacturing License. This framework ensures that devices like surgical probes meet quality, safety, and efficacy standards before entering the Indian healthcare ecosystem.

Risk Classification and License Requirements for Surgical Probe (Class A)

Class A devices, including surgical probes, are considered low risk. Consequently, manufacturers must apply for an MD5 license (using Form MD3) through the State Licensing Authority. The process includes obtaining a test license (Form MD13), product testing in government-approved labs, a notified body audit, and final license issuance.

Key points for Class A Surgical Probes:

• License Type: MD5 Manufacturing License
• Regulatory Authority: State Licensing Authority
• Application Forms: MD13 (Test License), MD3 (Manufacturing License)
• Process Duration: Approximately 3-4 months
• Fees: INR 5,000 per application + INR 500 per product

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

Manufacturing License Process for Surgical Probes (MD5)

1. Apply for Test License (Form MD13): Initiate the process by obtaining a test license, valid for 12 months, allowing the conduction of product testing. This step typically takes 1.5 to 2 months.

2. Product Testing: Surgical probes must undergo testing at government-approved laboratories. Testing parameters focus on material biocompatibility, sterility, mechanical integrity, and compliance with essential principles.

3. Document Preparation: Assemble comprehensive documentation including Device Master File, Plant Master File, Quality Management System (QMS) documents, Essential Principles Checklist, and Risk Management File.

4. Application Submission (Form MD3): Submit the manufacturing license application via the CDSCO MD Online Portal.

5. Notified Body Audit: The notified body appointed by CDSCO conducts an audit of your manufacturing facility and quality systems. Check the list of notified bodies to identify approved auditors.

6. Queries Resolution: Respond promptly to any queries or observations from the notified body or licensing authority.

7. License Grant: Upon satisfactory compliance, the MD5 license is granted.

For an in-depth understanding, our MD5 License Guide provides step-by-step assistance.

Manufacturing License Documents Required for Surgical Probes

Ensuring completeness and accuracy of documentation is crucial. The key documents include:

• Company Constitution (Incorporation Certificate, Memorandum & Articles of Association)
• Proof of Ownership or Legal Occupancy of Manufacturing Premises
• Details and Qualifications of Technical Staff
• Fire NOC and Pollution Control Board Clearance
• Device Master File (DMF) detailing design, specifications, and manufacturing process (Device Master File Guide)
• Plant Master File describing manufacturing setup and quality systems (Plant Master File Guide)
• Essential Principles Checklist demonstrating compliance with Indian regulations
• Risk Management File documenting hazard analysis and mitigation (Risk Management)
• Test Reports from CDSCO-approved laboratories (Testing Laboratories)
• Product Labels and Instructions for Use (IFU)
• Quality Management System (QMS) documentation such as ISO 13485 certificates

Import License Process for Surgical Probes (MD15)

While this guide primarily addresses manufacturing licenses, importers of surgical probes must seek an MD15 import license issued by the Central Licensing Authority. The process involves document submission, including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016 certification, CE certificates, and relevant master files.

The application is filed on the CDSCO MD Online Portal, with an expected processing time of 5-6 months. For detailed steps and document checklists, consult our Import License Guide.

Timeline and Processing Duration

Total Estimated Time: Approximately 3 to 4 months from start to finish.

Government Fees and Costs

• Test License (MD13): Typically included in overall application costs.
• MD5 License Fees: INR 5,000 per application plus INR 500 per product
• Testing Fees: Varies by laboratory; budget approximately INR 50,000 to INR 1,00,000 depending on tests
• Audit and Consulting Fees: Varies; anticipate INR 50,000 to INR 2,00,000 depending on notified body and consultancy support

Planning your budget with these costs in mind ensures smooth progression without financial surprises.

Common Challenges and Solutions

• Incomplete Documentation: Many applicants face delays due to missing or inconsistent documents. Solution: Use our detailed document checklists and templates.

• Delayed Product Testing: Testing bottlenecks occur if labs are overbooked. Solution: Schedule testing early and confirm lab availability.

• Audit Non-Compliance: Facility or QMS non-conformities lead to audit failures. Solution: Conduct pre-audit internal reviews and train staff thoroughly.

• Query Management: Slow response to regulatory queries delays license issuance. Solution: Assign dedicated personnel for timely communication.

Expert Consultation and Support

Navigating CDSCO licensing can be complex; partnering with experienced consultants accelerates approvals and mitigates risks. Our 25+ years of expertise, having supported over 500 companies, enables tailored solutions—from document preparation to audit readiness and post-approval compliance.

Getting Started with Your CDSCO License Application for Surgical Probes

1. Assess Device Classification: Confirm your surgical probe’s Class A status and regulatory requirements.

2. Initiate Test License Application: Prepare and submit Form MD13 via the CDSCO MD Online Portal.

3. Plan Product Testing: Book slots with approved labs early to avoid delays.

4. Prepare Comprehensive Documentation: Utilize our guides on Device Master Files and Plant Master Files to ensure compliance.

5. Schedule Notified Body Audit: Contact an approved notified body from the official list to plan your audit.

6. Submit Manufacturing License Application (Form MD3): Once testing and documentation are complete, file your application online.

7. Respond Promptly to Queries: Prepare to address any observations swiftly for timely license grant.

By following these actionable steps, manufacturers of surgical probes can confidently navigate the CDSCO licensing process, ensuring compliance, market access, and patient safety in India.