CDSCO License for Laparoscopic grasping forceps, Non sterile

Comprehensive Guide to CDSCO Licensing for Laparoscopic Grasping Forceps (Class A Medical Device)

Navigating the regulatory landscape for medical devices in India, especially for specialized instruments like laparoscopic grasping forceps, requires clarity and precision. With over 25 years of experience assisting more than 500 companies in securing CDSCO licenses, we provide you with a detailed roadmap tailored for the Class A laparoscopic grasping forceps (non-sterile) under the gastroenterology category.

Understanding Your Device: Laparoscopic Grasping Forceps

Laparoscopic grasping forceps are rigid surgical instruments designed to be introduced through a laparoscope for the primary purpose of grasping and manipulating tissues during minimally invasive surgeries. Despite your device being labeled non-sterile, it plays a critical role in surgical procedures, demanding strict adherence to regulatory standards to ensure safety and efficacy.

CDSCO Regulatory Framework for Class A Medical Devices

In India, the Central Drugs Standard Control Organization (CDSCO) regulates medical devices through a risk-based classification system. Your laparoscopic grasping forceps, classified as Class A, fall under the lowest risk category, which means the licensing process is overseen by the State Licensing Authority rather than the Central Licensing Authority.

To legally manufacture and market this device in India, you must obtain an MD5 manufacturing license, which corresponds to Class A and B devices. This process involves securing a test license (MD13), product testing, documentation, and audit by a notified body.

Risk Classification and License Requirements for Laparoscopic Grasping Forceps

• Risk Class: A (Low risk)
• License Type: MD5 Manufacturing License
• Governing Authority: State Licensing Authority
• Applicable Notification: 29/Misc./03/2020-DC (182), dated 27.09.2021

For further details on device classification, you may consult the Medical Device Classification guide.

Step-by-Step Manufacturing License Process (MD5) for Class A Devices

1. Obtain Test License (Form MD13): Before manufacturing, apply for a test license to produce samples for testing. This takes approximately 1.5 to 2 months.

2. Product Testing: Submit your laparoscopic grasping forceps samples to a CDSCO-approved testing laboratory. Refer to the Testing Laboratories list for authorized labs.

3. Document Preparation: Compile comprehensive documentation including Device Master File, Plant Master File, Quality Management System (QMS) records, and risk management files.

4. Apply for Manufacturing License (Form MD3): Submit your application with complete documents via the CDSCO MD Online Portal.

5. Audit by Notified Body: A notified body will conduct an on-site audit to verify compliance. You can check the list of notified bodies authorized for such audits.

6. Query Resolution: Address any queries raised by the licensing authority or notified body promptly.

7. Grant of License (Form MD5): Upon successful audit and document verification, the manufacturing license is granted.

Detailed Document Requirements for MD5 License Application

For your laparoscopic grasping forceps, the documentation must be thorough and precise:

• Company Constitution Documents: Incorporation certificate, memorandum and articles of association
• Proof of Ownership or Lease of Manufacturing Premises
• Technical Staff Qualification and Experience Certificates: To demonstrate adequate technical expertise
• Fire NOC and Pollution Control NOC: Compliance with environmental and safety regulations
• Device Master File (DMF): Detailed product specifications, design, and manufacturing process. Our Device Master File guide provides valuable insights.
• Plant Master File (PMF): Details about the manufacturing facility, equipment, and processes. Refer to our Plant Master File guide.
• Essential Principles Checklist: Demonstrating compliance with CDSCO’s essential principles for medical devices
• Risk Management File: Including risk analysis and mitigation strategies as per ISO 14971. Check our Risk Management guide.
• Test Reports: From government-approved testing laboratories
• Labels and Instructions for Use (IFU): Ensuring clear communication to end-users
• Quality Management System (QMS) Documentation: ISO 13485:2016 compliance evidence

Import License Process (MD15) for Laparoscopic Grasping Forceps

Though your device is non-sterile and Class A, if you plan to import laparoscopic grasping forceps, you must apply for an MD15 import license from the Central Licensing Authority. The process includes:

• Document preparation including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485 certificate, CE certificate (if applicable), DMF, PMF, and wholesale license
• Application submission via the CDSCO MD Online Portal
• Resolution of any queries raised by CDSCO
• License issuance typically within 5-6 months

For more details, visit our Import License guide.

Timeline and Processing Duration for MD5 License

Proper planning and prompt responses to queries can ensure you meet these timelines effectively.

Government Fees and Costs

• Test License (MD13): Approximately Rs. 5,000 (varies by state)
• MD5 License Application: Rs. 5,000 per application plus Rs. 500 per product

For example, if you are applying for one product (laparoscopic grasping forceps), the total fee would be Rs. 5,500.

Common Challenges and Practical Solutions

• Delayed Testing Results: Engage with government-approved labs early and understand their turnaround times. Maintaining a good relationship with labs can expedite testing.

• Incomplete Documentation: Use checklists and consult experts to ensure no documents are missing. Our guides on Device and Plant Master Files are invaluable.

• Audit Non-Compliance: Prepare your facility and QMS thoroughly. Conduct internal mock audits before the notified body visit.

• Query Resolution Delays: Assign a dedicated regulatory officer to monitor and respond promptly.

Expert Consultation and Support

With 25+ years of regulatory expertise, we have helped numerous manufacturers and importers streamline their CDSCO licensing process. Our hands-on support includes:

• Detailed gap analysis of your documentation
• Assistance in preparing DMF and PMF
• Coordination with notified bodies and testing labs
• End-to-end application submission and query management

Feel free to reach out to leverage our expertise for a hassle-free licensing experience.

Getting Started with Your CDSCO License Application

1. Register on the CDSCO MD Online Portal: This is mandatory for all application submissions.

2. Initiate Test License Application (MD13): Begin sample production and testing early.

3. Prepare Your Documentation: Use our guides as templates to ensure completeness.

4. Schedule Testing and Audit: Coordinate timelines keeping processing durations in mind.

5. Submit Manufacturing License Application (Form MD3): Once test license and testing are complete.

6. Stay Responsive: Monitor your application status online and respond swiftly to queries.

By following these actionable steps and utilizing our expertise, securing your MD5 manufacturing license for laparoscopic grasping forceps will be a structured and efficient journey towards entering the Indian medical device market.