CDSCO License for Non-sterile Scalpel
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
An instrument used to sever and separate body tissues during surgery.
Introduction to Non-sterile Scalpel and Regulatory Importance
A Non-sterile Scalpel is a fundamental surgical instrument designed to sever and separate body tissues during operations. Despite being non-sterile, this device’s precision and safety are critical in any operation theatre setting. In India, the Central Drugs Standard Control Organization (CDSCO) mandates strict regulatory compliance to ensure the safety and efficacy of such devices before they enter the market. Compliance not only guarantees patient safety but also smooth market access and legal conformity.
CDSCO Regulatory Framework for Non-sterile Scalpel (Class A Device)
The CDSCO regulates medical devices through a risk-based classification system. As a Class A device, the Non-sterile Scalpel falls under the lowest risk category. However, even Class A devices must comply with the Medical Device Rules, 2017, including licensing, quality management, and labelling requirements. The regulatory framework ensures that manufacturers maintain consistent quality and safety standards.
Risk Classification and License Requirements
Non-sterile Scalpels are classified as Class A devices due to their low risk profile. This classification requires manufacturers to obtain an MD5 Manufacturing License from the State Licensing Authority. Importers must secure an MD15 Import License granted by the Central Licensing Authority. Understanding these distinctions is crucial to determine the correct application pathway.
Manufacturing License Process (MD5) for Non-sterile Scalpel
For manufacturing Non-sterile Scalpels in India, the MD5 license process involves several key steps:
Test License (Form MD13): Initially, the manufacturer must apply for a test license, which allows limited production for testing purposes. This step takes approximately 1.5 to 2 months.
Product Testing: The scalpel must be tested at CDSCO-approved laboratories to verify compliance with applicable standards. Refer to the list of testing laboratories for approved facilities.
Documentation Preparation: Compile all required documents including technical files, quality management system (QMS) documents, and risk management files.
License Application (Form MD3): Submit the manufacturing license application through the CDSCO MD Online Portal.
Audit by Notified Body: An audit by a CDSCO-notified body is conducted to verify compliance. You can check the list of notified bodies for audit assignments.
Query Resolution: Address any queries raised by the licensing authority or notified body promptly.
License Grant (Form MD5): Upon satisfactory completion of all steps, the MD5 license is granted.
The entire process typically takes 3 to 4 months.
Manufacturing License Documents Required for Non-sterile Scalpel
Accurate documentation is the backbone of your license application. For a Class A device like the Non-sterile Scalpel, you should prepare:
- Company Constitution and Incorporation Certificates
- Proof of Ownership or Lease of Manufacturing Premises
- Details and Qualifications of Technical Staff
- Fire NOC and Pollution Control Board NOC
- Device Master File (DMF) detailing design and specifications (Device Master File Guide)
- Plant Master File (PMF) outlining manufacturing processes (Plant Master File Guide)
- Essential Principles Checklist demonstrating compliance with safety requirements
- Risk Management File specific to the scalpel (Risk Management Guide)
- Test Reports from CDSCO-approved laboratories
- Product Labels and Instructions for Use (IFU)
- Quality Management System (QMS) documents, preferably ISO 13485:2016 certified
Import License Process (MD15) for Non-sterile Scalpel
Importers of Non-sterile Scalpels must obtain an MD15 license from the Central Licensing Authority. The process includes:
Document Preparation: Gather necessary documents such as Manufacturing License of the foreign manufacturer, Free Sale Certificate, ISO 13485:2016 certification, CE Certificate if applicable, and relevant device master and plant master files.
Application Submission: File the application on the CDSCO MD Online Portal using Form MD14.
Departmental Review and Query Resolution: Respond promptly to any queries raised.
License Grant (Form MD15): Upon clearance, the import license is issued.
The import process usually takes 5 to 6 months.
Import License Documents Required
- Manufacturing License of the foreign manufacturer
- Free Sale Certificate or Certificate of Exportability
- ISO 13485:2016 Certificate
- CE Certificate or equivalent
- Device Master File
- Plant Master File
- Wholesale License of Indian Importer (if applicable)
- Company Constitution and Incorporation Documents
Timeline and Processing Duration
| Process Step | Duration |
|---|---|
| Test License (MD13) | 1.5 to 2 months |
| Product Testing | 2 to 4 weeks |
| Document Preparation | 2 to 4 weeks |
| MD5 License Application Review | 1 to 2 months |
| Audit and Query Resolution | 3 to 4 weeks |
| Total Manufacturing License Time | 3 to 4 months |
| Import License (MD15) | 5 to 6 months |
Government Fees and Costs
For a Class A device like Non-sterile Scalpel, the fee structure is as follows:
MD5 Manufacturing License
- Application Fee: ₹5,000
- Per Product Fee: ₹500
Test License (MD13)
- Application Fee: Included in manufacturing license process
MD15 Import License
- Application Fee for Class A: $1,000 per site
- Per Product Fee: $50
These fees are payable online via the CDSCO portal.
Common Challenges and Practical Solutions
Challenge 1: Delays in test lab approvals
- Solution: Engage with CDSCO-approved labs early in the process and ensure submission of complete samples to avoid retesting delays.
Challenge 2: Incomplete documentation
- Solution: Use comprehensive checklists and consult templates such as our Device Master File guide to ensure completeness.
Challenge 3: Audit non-compliance
- Solution: Perform internal audits using notified body checklists before scheduling the official audit.
Challenge 4: Query resolution delays
- Solution: Assign a dedicated regulatory expert to respond promptly and accurately to queries.
Expert Consultation and Support
With over 25 years of experience and having assisted 500+ companies, we provide end-to-end regulatory consulting tailored to Non-sterile Scalpel manufacturers and importers. From documentation to audit preparation and query management, our expert team ensures a smooth license acquisition process.
Getting Started with Your CDSCO License Application
Assess Your Device Classification: Confirm that your scalpel is Class A using the Medical Device Classification tool.
Initiate Test License Application: Prepare and submit Form MD13 via the CDSCO MD Online Portal to begin limited manufacturing.
Engage with Testing Laboratories: Coordinate with CDSCO-approved labs early for product testing.
Compile Complete Documentation: Use our Device Master File and Plant Master File guides to prepare.
Submit Manufacturing License Application (MD5): File Form MD3 through the portal and schedule the notified body audit.
Prepare for Audit and Query Management: Conduct pre-audit preparedness and assign dedicated staff for timely query responses.
Plan for Import Licensing if Applicable: If importing, start the MD15 process concurrently to avoid market entry delays.
Embarking on the CDSCO licensing journey for your Non-sterile Scalpel can be complex, but with meticulous planning and expert guidance, you can achieve timely compliance and market access in India.
