CDSCO License for Hip System Instrument

Comprehensive Guide to CDSCO Licensing for Hip System Instrument (Class B Medical Device)

At our consultancy, with over 25 years of experience and having successfully supported 500+ companies, we understand the critical importance of regulatory compliance for medical devices like the Hip System Instrument. This surgically invasive, manually operated instrument assists orthopaedic surgeries, specifically in the implantation of femoral or acetabular components in total or hemiarthroplasty. Classified as Class B under CDSCO regulations, it falls under the General Hospital or Orthopaedic Instruments category, notified vide 29/Misc./03/2020-DC (193)-Part-3 dated 16.03.2022.

Navigating the CDSCO licensing process for such devices requires detailed knowledge of India’s regulatory framework, timelines, documentation, and cost structures. This guide provides a practical, step-by-step approach tailored specifically for manufacturers and importers of Hip System Instruments.

CDSCO Regulatory Framework for Hip System Instrument

The Central Drugs Standard Control Organization (CDSCO) regulates medical devices under the Medical Device Rules, 2017, ensuring safety, efficacy, and quality. For the Hip System Instrument, being a Class B device, the manufacturing license is issued by the State Licensing Authority through the MD5 license route (form MD3 application).

This device is surgically invasive but manually operated, and it is important to note that it does not include the implant itself—only the instruments used during surgery. The notification 29/Misc./03/2020-DC (193)-Part-3 dated 16.03.2022 classifies these instruments clearly under Class B.

Risk Classification and License Requirements

• Risk Class: B (Moderate risk)
• License Type: MD5 (Manufacturing License for Class A & B devices)
• Issuing Authority: State Licensing Authority
• Applicable Rule: Medical Device Rules, 2017

Being Class B implies a moderate regulatory control level, requiring rigorous testing, documentation, and audit but a comparatively simpler process than Class C or D devices.

Manufacturing License Process (MD5 License)

The process to obtain the MD5 license for Hip System Instruments involves several critical steps:

1. Test License (Form MD13): Before the manufacturing license, you must obtain a test license. This allows you to manufacture and test your devices for compliance.
2. Product Testing: Samples of the device must be tested in CDSCO-recognized government-approved laboratories. You can find the relevant Testing Laboratories here.
3. Document Preparation: Prepare all mandatory documents including Device Master File (DMF), Plant Master File (PMF), Quality Management System (QMS) documents, risk management files, and more.
4. Application Submission: Submit your application on the CDSCO MD Online Portal using Form MD3.
5. Audit by Notified Body: A notified body will conduct a detailed audit of your manufacturing facility and QMS. See the list of notified bodies for audit agencies.
6. Resolution of Queries: Promptly address any queries or deficiencies raised by the CDSCO or the notified body.
7. License Grant: Upon successful compliance, the State Licensing Authority issues the MD5 license (Form MD5).

Manufacturing License Documents Required

For the Hip System Instrument Class B device, prepare the following key documents:

• Company Constitution (Incorporation Certificate, MOA/AOA)
• Proof of ownership or lease agreement of manufacturing premises
• Details and qualifications of technical staff
• Fire No Objection Certificate (NOC)
• Pollution Control Board NOC
• Device Master File (DMF) detailing design and specifications (Device Master File Guide)
• Plant Master File (PMF) describing manufacturing processes (Plant Master File Guide)
• Essential Principles Checklist
• Risk Management File tailored to the device (Risk Management Guide)
• Test Reports from government-approved laboratories
• Labeling and Instructions for Use (IFU)
• Quality Management System documentation aligned with ISO 13485

Attention to detail in these documents can significantly streamline the audit and approval process.

Import License Process (MD15 License)

If you are an importer of Hip System Instruments, the import license MD15 is mandatory and issued by the Central Licensing Authority. The process involves:

• Document preparation including Manufacturing License from the country of origin, Free Sale Certificate, ISO 13485:2016 certification, CE certificate, DMF, PMF, wholesale license, and company constitution.
• Application submission on the CDSCO MD Online Portal using Form MD14.
• Queries resolution and final license grant (Form MD15).

The typical timeline for this process is 5-6 months.

Import License Documents Required

• Valid Manufacturing License of the device from the country of origin
• Free Sale Certificate
• ISO 13485:2016 certification
• CE Certificate
• Device Master File
• Plant Master File
• Wholesale License
• Company Constitution

Timeline and Processing Duration

Total approximate time: 3 to 4 months from test license application to MD5 license grant.

Government Fees and Costs

For Class B devices like Hip System Instruments, the fee structure is as follows:

• Test License (MD13): Rs. 5000 per application
• Manufacturing License (MD5): Rs. 5000 per application + Rs. 500 per product

Budgeting for additional costs such as notified body audit fees, product testing charges, and consultancy support is essential. For example, notified body audits may range from Rs. 50,000 to Rs. 1,00,000 depending on the scope.

Common Challenges and Solutions

Challenge: Delays in product testing due to sample non-conformance.

Solution: Conduct pre-tests in accredited private labs to identify issues before government lab submission.

Challenge: Incomplete or non-compliant documentation.

Solution: Utilize expert consultancy to ensure your Device Master File and Risk Management File meet CDSCO expectations.

Challenge: Audit non-compliance findings.

Solution: Perform internal mock audits and remedial actions prior to notified body audits.

Expert Consultation and Support

Our extensive experience with over 500 successful CDSCO licenses means we can guide you through every step—from initial classification and documentation to audit readiness and final submission. We help you avoid common pitfalls, ensure speedy approvals, and maintain compliance post-license.

Getting Started with Your CDSCO License Application

1. Classify your device accurately: Confirm your Hip System Instrument as Class B under current notifications.
2. Prepare your test license application: Compile necessary documents and submit Form MD13 via the CDSCO MD Online Portal.
3. Coordinate product testing: Engage with government-approved labs listed on the CDSCO portal.
4. Develop robust Device and Plant Master Files: Reference our guides for comprehensive file preparation.
5. Schedule notified body audit: Choose from the list of notified bodies to book your audit.
6. Submit your manufacturing license application: Apply on the CDSCO portal using Form MD3.
7. Respond promptly to queries: Maintain communication with CDSCO and auditors to expedite approvals.

By following these targeted steps and leveraging expert support, manufacturers and importers of Hip System Instruments can successfully navigate the CDSCO licensing process and establish a strong presence in the Indian market.

For personalized assistance or detailed consultancy, contact us to leverage our 25+ years of regulatory expertise and ensure your device’s timely approval and market entry.