CDSCO License for Clamping and Occluding Surgical instruments
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
These are transient use invasive surgical instruments, intended for use in many surgical procedures for compressing blood vessels or hollow organs. In order to prevent their contents from leaking or control bleeding or Occlude. They are designed straight, curved or angled, or ratcheted and have a variety of inner jaw patterns.
Comprehensive Guide to CDSCO Licensing for Clamping and Occluding Surgical Instruments (Class A)
Manufacturers and importers of Clamping and Occluding Surgical Instruments, classified as Class A medical devices under the Indian regulatory framework, must navigate the Central Drugs Standard Control Organization (CDSCO) licensing process carefully to enter the Indian market legally. These surgical instruments, designed for transient invasive use to compress blood vessels or hollow organs during surgery, require stringent compliance with Indian medical device regulations to ensure safety and efficacy.
With over 25 years of experience and having successfully assisted more than 500 companies in obtaining CDSCO licenses, we provide detailed, actionable insights specifically for Class A surgical instruments like these, including timelines, costs, document requirements, and common challenges.
CDSCO Regulatory Framework for Clamping and Occluding Surgical Instruments
The CDSCO regulates medical devices in India based on risk classification as per the Medical Device Rules, 2017. Clamping and Occluding Surgical Instruments fall under Class A (Low Risk) due to their transient invasive nature and limited risk profile. This mandates compliance primarily with the State licensing authority via the MD5 license.
The regulatory framework is designed to ensure:
- Safety and quality of medical devices.
- Proper manufacturing practices.
- Traceability and accountability.
As per the notification F. No. 29/Misc./03/2022-DC (228) dated 9.9.2022, these instruments are explicitly categorized under surgical instruments.
Risk Classification and License Requirements for Class A Devices
Class A devices like clamping and occluding instruments are considered low risk and require the MD5 Manufacturing License issued by the respective State Licensing Authority. This license confirms that the manufacturing site and processes comply with regulatory norms.
Key points:
- License Type: MD5 (Form MD3 application)
- Issued by: State Licensing Authority
- Risk Class: A (Low Risk)
- Total process time: Approximately 3-4 months
- Fees: Rs. 5,000 per application + Rs. 500 per product
For more on classification, refer to our detailed Medical Device Classification guide.
Manufacturing License Process (MD5) for Clamping and Occluding Surgical Instruments
The MD5 license process involves several critical steps:
- Test License (MD13 Form): Obtain a test license valid for 3-6 months to start product testing.
- Product Testing: Conduct product tests at government-approved labs to verify compliance.
- Document Preparation: Compile essential documents including Device Master File, Plant Master File, Risk Management File, and Quality Management System (QMS) records.
- Application Submission: File the MD5 license application (Form MD3) through the CDSCO MD Online Portal.
- Audit by Notified Body: Undergo a mandatory audit by a notified body listed on the Notified Bodies List.
- Query Resolution: Respond promptly to any queries raised by the licensing authority or notified body.
- License Grant: Receive the MD5 manufacturing license (Form MD5) upon successful compliance.
Manufacturing License Documents Required for Class A Surgical Instruments
Preparing a comprehensive and compliant document package is essential to avoid delays. For clamping and occluding surgical instruments, the following documents are mandatory:
- Company Constitution Documents (e.g., Incorporation Certificate, Partnership Deed)
- Proof of Ownership or Lease of Manufacturing Premises
- Technical Staff Qualification and Experience Details
- Fire NOC and Pollution Control Certificate
- Device Master File (DMF): Detailed device specifications, design, manufacturing process (Device Master File Guide)
- Plant Master File (PMF): Information on manufacturing facilities and equipment (Plant Master File Guide)
- Essential Principles Checklist: Demonstrating adherence to safety and performance requirements
- Risk Management File: Hazard analysis and mitigation strategies (Risk Management)
- Product Test Reports from CDSCO-approved testing laboratories (Testing Laboratories)
- Labels and Instructions for Use (IFU)
- Quality Management System Documents (e.g., ISO 13485 certification, SOPs, batch records)
Import License Process (MD15) for Surgical Instruments
Although your device is Class A and primarily requires an MD5 license for manufacturing, importers of clamping and occluding surgical instruments must secure an MD15 Import License issued by CDSCO Central Licensing Authority.
The MD15 process includes:
- Document preparation including the manufacturing license from the country of origin, Free Sale Certificate, ISO 13485, CE certificate, Device and Plant Master Files.
- Application submission on the CDSCO MD Online Portal using Form MD14.
- Resolution of departmental queries.
- License grant on Form MD15.
The import license timeline is approximately 5-6 months, and fees depend on device class:
- Class A: 50 per product
Detailed steps and requirements can be found in our Import License Guide.
Timeline and Processing Duration for MD5 License
| Stage | Timeline |
|---|---|
| Test License (MD13) | 1.5 to 2 months |
| Product Testing | 1 to 1.5 months |
| Application Preparation | 2 to 3 weeks |
| Audit and Inspection | 3 to 4 weeks |
| Query Resolution & Approval | 2 to 3 weeks |
| Total Duration | 3 to 4 months approx. |
Timely submission of complete documentation and prompt responses to queries significantly reduce delays.
Government Fees and Costs Breakdown
| Fee Type | Amount (INR) |
|---|---|
| Application Fee | Rs. 5,000 |
| Per Product Fee | Rs. 500 |
| Testing Fees | Varies by lab, typically Rs. 50,000 - Rs. 1,00,000 (for full test battery) |
| Notified Body Audit Fee | Rs. 50,000 - Rs. 1,00,000 approx (varies by body) |
Manufacturers should budget for these fees upfront to avoid financial bottlenecks.
Common Challenges and Practical Solutions
Challenge 1: Incomplete Documentation
- Solution: Use a detailed checklist and consult experienced regulatory experts to ensure all documents, including DMF, PMF, and risk management files, are complete.
Challenge 2: Delays in Product Testing
- Solution: Choose CDSCO-approved labs with shorter turnaround times. Plan testing early during the test license period.
Challenge 3: Audit Non-Compliance
- Solution: Conduct internal mock audits before the notified body inspection. Ensure your QMS and manufacturing processes are audit-ready.
Challenge 4: Query Management
- Solution: Respond precisely and promptly to CDSCO and notified body queries, providing substantiated evidence.
Expert Consultation and Support
Our team, with decades of regulatory expertise, offers end-to-end support from documentation preparation to audit readiness and liaison with CDSCO authorities. We have successfully guided over 500 manufacturers through the MD5 licensing process for Class A surgical instruments.
We recommend early engagement to streamline the process, mitigate risks, and accelerate your time-to-market.
Getting Started with Your CDSCO License Application for Clamping and Occluding Surgical Instruments
- Assess Classification: Confirm the device is Class A under CDSCO rules.
- Obtain Test License (MD13): Apply via the CDSCO MD Online Portal.
- Schedule Product Testing: Book slots at CDSCO-approved labs.
- Prepare Comprehensive Documentation: Device Master File, Plant Master File, Risk Management, QMS, etc.
- Engage Notified Body: Select from the Notified Bodies List for audit scheduling.
- Submit MD5 Application (Form MD3): Once testing and documentation are complete.
- Prepare for and Clear Audit: Conduct internal reviews before notified body inspection.
- Respond to Queries Promptly: Keep communication clear and timely.
- Receive License and Launch: Begin manufacturing legally in India.
By following these precise steps, manufacturers of clamping and occluding surgical instruments can confidently navigate the CDSCO regulatory landscape and successfully obtain their MD5 license.
For tailored assistance, feel free to contact our regulatory consulting team dedicated to medical device compliance in India.
