CDSCO License for Non-sterile Surgical  probe

Comprehensive Guide to CDSCO Licensing for Non-sterile Surgical Probes (Class A Medical Devices)

As a company with over 25 years of expertise in medical device regulatory compliance, having assisted 500+ manufacturers and importers successfully navigate the CDSCO licensing process, we understand the critical importance of clear, actionable guidance. This article covers everything you need to know to obtain the CDSCO license for your Non-sterile Surgical Probe, a Class A device used to explore sinuses, fistulae, and other cavities and wounds in the operation theatre.

Understanding the Non-sterile Surgical Probe and Its Regulatory Significance

Non-sterile surgical probes are vital tools for surgeons to examine and explore internal cavities without direct invasion or contamination risk. Since these devices come into contact with mucous membranes or non-sterile surfaces, regulatory oversight ensures safety, efficacy, and quality before market entry.

India’s Central Drugs Standard Control Organization (CDSCO) mandates licensing for these devices under its Medical Device Rules, 2017, aligning with international standards to safeguard public health.

CDSCO Regulatory Framework for Non-sterile Surgical Probes

The regulatory pathway for your Non-sterile Surgical Probe falls under the CDSCO Medical Device Rules, 2017, notified through File No. 29/Misc/03/2020-DC (199) dated 13.09.2021. These rules classify medical devices into four risk categories - A, B, C, and D - based on intended use and risk to patients.

As a Class A device (low risk), your probe requires a manufacturing license issued by the State Licensing Authority, under the MD5 license category.

Risk Classification and License Requirements for Class A Devices

Class A devices are considered low-risk and have streamlined licensing requirements:

• License Type: MD5 Manufacturing License
• Regulatory Authority: State Licensing Authority
• Application Form: MD3 for license application, MD13 for test license
• Timeline: Approximately 3-4 months
• Government Fees: Rs 5,000 per application + Rs 500 per product

For detailed classification, visit our Medical Device Classification guide.

Manufacturing License Process (MD5) for Non-sterile Surgical Probe

The manufacturing license process involves several critical steps:

1. Apply for Test License (MD13): Before full manufacturing approval, you must obtain a test license which allows you to produce samples for testing. This takes about 1.5 to 2 months.

2. Product Testing at Approved Labs: Samples must be tested in government-approved laboratories to verify compliance with essential principles. Refer to the list of approved testing laboratories.

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

4. License Application Submission: Submit the MD5 license application (Form MD3) through the CDSCO MD Online Portal.

5. Audit by Notified Body: A notified body conducts a factory audit to verify compliance; check the list of notified bodies for eligible auditors.

6. Resolution of Queries: Address any queries raised by CDSCO or the notified body promptly.

7. Grant of License: Upon satisfactory review, CDSCO issues the MD5 manufacturing license (Form MD5).

Manufacturing License Documents Required

For your Non-sterile Surgical Probe, the following documentation is mandatory:

• Company Constitution (Incorporation Certificate, MOA/AOA)
• Proof of Premises Ownership or Lease
• Technical Staff Qualification and Experience
• Fire NOC and Pollution Control Board NOC
• Device Master File (detailed device specifications, design, and validation) - see our DMF guide
• Plant Master File (manufacturing site details) - refer to our PMF guide
• Essential Principles Checklist confirming compliance with Indian Medical Device Rules
• Risk Management File (hazard analysis and mitigation strategies) - learn more about risk management
• Test Reports from approved laboratories
• Product Labels and Instructions for Use (IFU)
• Quality Management System (QMS) documents including SOPs and CAPA

Import License Process (MD15) for Non-sterile Surgical Probe

If you intend to import your Class A Non-sterile Surgical Probe into India, the MD15 license is mandatory. This license is granted by the Central Licensing Authority and typically takes about 5-6 months.

The application form is MD14, and unlike manufacturing licenses, a test license is not required for imports. However, you must submit valid manufacturing licenses from the country of origin, free sale certificates, and quality certificates such as ISO 13485:2016 and CE certification.

For detailed guidance, refer to our Import License guide.

Import License Documents Required

• Manufacturing License from the country of origin
• Free Sale Certificate
• ISO 13485:2016 Certificate
• CE Certificate (if applicable)
• Device Master File
• Plant Master File
• Wholesale License in India
• Company Constitution Documents

Timeline and Processing Duration for MD5 License

• Test License (MD13): 1.5 to 2 months
• Product Testing: 3-4 weeks depending on lab
• Document Preparation: 2-3 weeks (can overlap with testing)
• Application Submission and Audit: 1-1.5 months
• Query Resolution and Final Grant: 2-3 weeks

Total approximate duration: 3 to 4 months

Government Fees and Costs

• Application Fee: Rs 5,000 per application
• Product Fee: Rs 500 per product
• Notified Body Audit Fees: Varies by auditor (approx Rs 50,000 to Rs 1,00,000)
• Testing Lab Charges: Approx Rs 30,000 to Rs 50,000 depending on test scope

Common Challenges and Practical Solutions

Challenge: Delays in test report issuance due to backlog at government labs.

Solution: Plan early, submit samples promptly, and consider private notified labs approved by CDSCO to expedite testing.

Challenge: Incomplete or inconsistent documentation leading to query escalations.

Solution: Engage experienced regulatory consultants to prepare and review documents before submission.

Challenge: Audit non-compliance due to site readiness issues.

Solution: Conduct internal mock audits and ensure all QMS and facility requirements meet notified body standards.

Expert Consultation and Support

Navigating CDSCO licensing, particularly for Class A devices like the Non-sterile Surgical Probe, requires in-depth knowledge of regulatory nuances, documentation standards, and process timelines. Our proven track record with 500+ companies ensures that you receive tailored, practical support to avoid common pitfalls and secure license approval efficiently.

Getting Started with Your CDSCO License Application

1. Assess Your Device Classification: Confirm your device falls under Class A by reviewing the Medical Device Classification.

2. Prepare Comprehensive Documentation: Start assembling your Device Master File, Plant Master File, and QMS documents.

3. Apply for Test License (MD13): Submit your application via the CDSCO MD Online Portal to initiate manufacturing test license processing.

4. Plan Product Testing: Coordinate with government-approved labs early to reduce delays.

5. Schedule Notified Body Audit: Choose an appropriate notified body from the list here and prepare your facility accordingly.

6. Submit MD5 License Application: After successful testing and audit, file your MD5 license application with the State Licensing Authority.

By following these actionable steps and leveraging expert guidance, your Non-sterile Surgical Probe can reach the Indian market compliantly and efficiently.

For personalized assistance and turnkey regulatory support, connect with our expert consultants who specialize in CDSCO medical device licensing.