CDSCO License for Jet lavage.
Medical Device Information
Intended Use
A jet lavage is a device used to clean a wound by a pulsatile jet of sterile fluid.
Comprehensive Guide to CDSCO Licensing for Jet Lavage Medical Devices
Jet lavage devices play a crucial role in healthcare settings by delivering a pulsatile jet of sterile fluid to effectively clean wounds. Classified under Class B medical devices according to the CDSCO framework, these instruments fall within the "General Hospital or Orthopaedic Instruments" category. Ensuring compliance with India's regulatory requirements is essential to legally manufacture or import jet lavage devices. With over 25 years of experience and having assisted more than 500 companies in securing CDSCO licenses, we provide you with actionable insights to navigate the regulatory pathway with confidence.
CDSCO Regulatory Framework for Jet Lavage Devices
The Central Drugs Standard Control Organization (CDSCO) governs the approval, licensing, and regulation of medical devices in India. Jet lavage devices are notified under the notification number 29/Misc./03/2020-DC (193)- Part-3 dated 16.03.2022. As a Class B device, they require a manufacturing license known as the MD5 license, issued by the State Licensing Authority. This license ensures that manufacturers comply with safety, quality, and efficacy standards before placing the device in the Indian market.
Risk Classification and License Requirements
Jet lavage devices are categorized as Class B due to their moderate risk profile; they are invasive devices but non-implantable with limited duration of contact with the body. The classification mandates obtaining an MD5 manufacturing license (Form MD3) for local manufacturers or an MD15 import license for importers.
- Class B Device: MD5 Manufacturing License
- Regulatory Authority: State Licensing Authority
- Applicable Notification: 29/Misc./03/2020-DC (193)- Part-3
For detailed classification, manufacturers can review the Medical Device Classification guide.
Manufacturing License Process (MD5) for Jet Lavage Devices
The MD5 license process is comprehensive and involves multiple stages:
- Test License (Form MD13): Initiate with a test license application to enable product testing. This stage typically takes 1.5 to 2 months.
- Product Testing: Conduct testing at CDSCO-approved laboratories. For jet lavage devices, testing parameters include sterility, biocompatibility, and functionality. Refer to the list of testing laboratories for authorized labs.
- Document Preparation: Compile all required documentation, including Device Master File and Plant Master File.
- Application for MD5 License (Form MD3): Submit the manufacturing license application via the CDSCO MD Online Portal.
- Audit by Notified Body: A third-party audit is conducted by a notified body approved by CDSCO. You can check the list of notified bodies to choose your auditor.
- Query Resolution: Address any queries raised during audit or document review promptly.
- Grant of License: Upon satisfactory compliance, the MD5 license (Form MD5) is granted.
The entire process generally spans 3 to 4 months, assuming all documentation and testing are in order.
Manufacturing License Documents Required for Jet Lavage
To ensure a smooth application, prepare the following key documents:
- Company Constitution Documents: Incorporation certificate, partnership deed, etc.
- Proof of Ownership or Lease of Manufacturing Premises
- Technical Staff Credentials: Qualification certificates and experience letters for personnel.
- Fire NOC and Pollution Control NOC from local authorities.
- Device Master File (DMF): Details about the jet lavage device design, specifications, and manufacturing process. Our Device Master File guide offers practical tips.
- Plant Master File: Documentation of facility layout, equipment, and quality management system. See our Plant Master File guide for help.
- Essential Principles Checklist: Compliance with safety and performance standards.
- Risk Management File: Analysis and mitigation strategies tailored to jet lavage devices. Learn more about medical device risk management.
- Test Reports: From CDSCO-approved laboratories.
- Labels and Instructions for Use (IFU): In compliance with Indian regulations.
- Quality Management System (QMS) Documents: ISO 13485 certification and internal SOPs.
Import License Process (MD15) for Jet Lavage Devices
If you are an importer of jet lavage devices, the process differs slightly:
- License Type: MD15 Import License (Form MD14 application)
- Authority: Central Licensing Authority
- Process:
- Document preparation including manufacturing license, Free Sale Certificate, ISO 13485, CE Certificate
- Application submission on the CDSCO MD Online Portal
- Resolution of any queries raised by CDSCO
- License grant on Form MD15
The import license process typically takes 5 to 6 months due to thorough document scrutiny.
For detailed guidance, consult our Import License guide.
Import License Documents Required
- Valid Manufacturing License from the country of origin
- Free Sale Certificate
- ISO 13485:2016 certification
- CE Certificate (if applicable)
- Device Master File
- Plant Master File
- Wholesale License
- Company Constitution Documents
Timeline and Processing Duration
| License Type | Process Steps | Approximate Duration |
|---|---|---|
| MD5 License | Test License + Product Testing + Audit + License Grant | 3 to 4 months |
| MD15 License | Document Review + Queries + License Grant | 5 to 6 months |
Efficient preparation and proactive query resolution can significantly reduce delays.
Government Fees and Costs for Jet Lavage Licensing
| License Type | Application Fee | Per Product Fee |
|---|---|---|
| MD5 License | Rs. 5,000 | Rs. 500 |
| MD15 License | Rs. 1,000 to Rs. 3,000* | Rs. 50 to Rs. 1,500* |
*Fees for import licenses vary by device class and site; Class B devices typically incur Rs. 2,000 for site and Rs. 1,000 per product.
Additional costs include testing fees at government-approved labs and audit fees charged by notified bodies.
Common Challenges and Solutions
- Delayed Testing Results: Opt for accredited laboratories with faster turnaround times and track samples closely.
- Incomplete Documentation: Use comprehensive checklists and expert consultation to avoid missing critical documents like the Risk Management File or Plant Master File.
- Audit Non-compliance: Conduct internal audits prior to notified body visits to ensure readiness.
- Query Resolution Delays: Assign dedicated personnel for prompt response to regulatory queries.
Expert Consultation and Support
With more than two decades of regulatory expertise, we provide tailored consulting to streamline your CDSCO license application for jet lavage devices. Our services include:
- Gap analysis and document preparation
- Coordination with testing laboratories and notified bodies
- Training on QMS and risk management compliance
- End-to-end application submission and follow-up
Getting Started with Your CDSCO License Application for Jet Lavage
- Assess Your Device Classification: Confirm your jet lavage device's Class B status using official CDSCO resources.
- Gather Preliminary Documents: Compile company and facility documents, technical staff details, and essential certificates.
- Apply for the Test License (Form MD13): Submit via the CDSCO MD Online Portal.
- Engage a CDSCO-Approved Testing Laboratory: Schedule product testing promptly.
- Prepare Master Files and Compliance Documents: Utilize our recommended guides for Device Master File and Plant Master File.
- Select a Notified Body for Audit: Review options on the Notified Bodies List.
- Submit Manufacturing License Application (Form MD3): After test license and testing completion.
- Address Queries and Prepare for Audit: Maintain open communication with authorities for faster resolution.
Embarking on your CDSCO licensing journey with a structured plan and expert guidance can dramatically improve your chances of timely approval. Contact us to leverage our proven expertise in securing approvals for jet lavage and other Class B medical devices in India.
