CDSCO License for Microwave hyperthermia system catheter, prostatic- ablation, reusable

Comprehensive Guide to CDSCO Licensing for Microwave Hyperthermia System Catheter (Class C Medical Device)

Manufacturers and importers seeking to enter the Indian medical device market with a Microwave Hyperthermia System Catheter for prostatic ablation must navigate the Central Drugs Standard Control Organization (CDSCO) regulatory framework diligently. This reusable, Class C urology device plays a critical role in treating prostate disorders such as cancer, benign prostatic hyperplasia (BPH), and prostatitis by applying localized microwave heat. Given its moderate risk classification, the device requires an MD9 manufacturing license or MD15 import license, governed by the Central Licensing Authority.

With over 25 years of experience and having successfully supported 500+ companies in CDSCO licensing, we provide you with detailed, actionable insights tailored specifically to this device and its regulatory requirements.

CDSCO Regulatory Framework for Microwave Hyperthermia System Catheter

The CDSCO regulates medical devices under the Medical Device Rules (MDR) 2017, aligned with the Drugs and Cosmetics Act, 1940. The Microwave Hyperthermia System Catheter falls under Class C due to its invasive nature and moderate risk profile. Consequently, it's subject to stringent controls including mandatory testing, audits, and detailed documentation.

The device is notified under File No. 29/Misc./03/2020-DC (145) dated 23.8.2021, confirming its classification and regulatory pathway.

For comprehensive details on medical device classification, manufacturers can refer to the Medical Device Classification guide.

Risk Classification and License Requirements for Class C Devices

Class C devices like the Microwave Hyperthermia System Catheter require an MD9 Manufacturing License issued by the Central Licensing Authority. This process is more rigorous than for Class A/B devices due to the higher risk and intended use within the human body.

Key points:

• License Type: MD9 (Application Form MD7)
• Issuing Authority: CDSCO Central Licensing Authority
• Process Duration: Approximately 4-5 months inclusive of testing, audit, and query resolution
• Fees: INR 50,000 per application plus INR 1,000 per product

Manufacturing License Process (MD9) for Microwave Hyperthermia System Catheter

The manufacturing license process is multi-staged:

1. Test License Application (Form MD13): Mandatory before applying for MD9, taking 1.5 to 2 months to obtain.
2. Product Testing: Conduct testing at CDSCO-approved labs to validate safety and efficacy. Refer to the list of testing laboratories.
3. Document Preparation: Compile all required documents including Device Master File, Plant Master File, Essential Principles Checklist, and Risk Management File.
4. MD9 License Application: Submit Form MD7 via the CDSCO MD Online Portal.
5. Audit by CDSCO Inspectors: On-site inspection to verify compliance with quality management systems and manufacturing practices.
6. Query Resolution: Address any observations or deficiencies raised by CDSCO or auditors promptly.
7. Grant of License: Issuance of MD9 Manufacturing License upon successful completion of all prior steps.

For detailed guidance on the MD9 application, see our MD9 License Guide.

Manufacturing License Documents Required

Preparing a thorough and accurate document package is critical for timely approval. For the Microwave Hyperthermia System Catheter (Class C), you must provide:

• Company Constitution: Incorporation certificate, partnership deed, or equivalent
• Proof of Ownership of Premises: Lease deed or ownership documents
• Technical Staff Qualifications: CVs and certificates of competent personnel
• Fire NOC & Pollution Control NOC: Valid clearances demonstrating compliance with safety and environmental norms
• Device Master File (DMF): Detailed design, manufacturing processes, and specifications (Device Master File guide)
• Plant Master File (PMF): Description of manufacturing site and quality systems (Plant Master File guide)
• Essential Principles Checklist: Demonstrating compliance with Indian MDR essential principles
• Risk Management File: In line with ISO 14971 standards (Risk Management guide)
• Test Reports: From CDSCO notified testing labs
• Labels and Instructions for Use (IFU): Clear, compliant labeling and user manuals
• Quality Management System Documents: ISO 13485:2016 certification and internal SOPs

Import License Process (MD15) for Class C Devices

Importers of the Microwave Hyperthermia System Catheter need to secure an MD15 Import License from CDSCO Central Licensing Authority. The process generally takes 5-6 months.

Steps include:

• Document Preparation: Collect manufacturing license, Free Sale Certificate, ISO 13485 certification, CE certificate (if applicable), Device Master File, Plant Master File, wholesale license, and company constitution.
• Application Submission: File Form MD14 through the CDSCO MD Online Portal.
• Query Resolution: Respond promptly to any departmental inquiries.
• License Grant: Receive MD15 Import License upon satisfactory evaluation.

Government fees vary by risk class. For Class C devices, expect approximately $3,000 per site and$1,500 per product.

Comprehensive steps are detailed in our Import License Guide.

Timeline and Processing Duration

For imports (MD15), the total duration averages 5-6 months.

Government Fees and Costs

• MD9 Manufacturing License: INR 50,000 per application + INR 1,000 per product
• Test License (MD13): Nominal fees (varies by state)
• Product Testing: Costs depend on the number of tests and lab selected
• MD15 Import License: Approximately $3,000 per site +$1,500 per product for Class C

Budgeting realistically for these fees and timelines is essential to avoid delays.

Common Challenges and Solutions

• Incomplete Documentation: Avoid rejections by cross-checking documents against CDSCO checklists.
• Delays in Testing: Coordinate early with notified testing labs to schedule tests promptly.
• Audit Non-Compliance: Conduct internal audits beforehand and train staff to ensure readiness.
• Query Management: Assign dedicated personnel to respond quickly to CDSCO queries.

Collaborating with experienced regulatory consultants can significantly reduce these risks.

Expert Consultation and Support

As a trusted regulatory partner with 25+ years in the Indian medical device sector, we offer end-to-end support:

• Regulatory strategy formulation
• Document preparation and review
• Coordination with notified bodies and testing labs
• Audit preparedness and training
• Ongoing compliance support

Our expertise ensures smooth navigation through the complex CDSCO process, saving time and resources.

Getting Started with Your CDSCO License Application

1. Confirm Device Classification: Verify your device's Class C status and review applicable rules.
2. Prepare Essential Documents: Begin compiling your Device and Plant Master Files and Quality Management System documentation.
3. Apply for Test License (MD13): Initiate testing phase early to meet testing deadlines.
4. Engage with Notified Bodies: Identify and liaise with CDSCO-approved auditors (Notified Bodies List).
5. Submit Applications via Online Portal: Utilize the CDSCO MD Online Portal for all license submissions.
6. Plan for Audit and Query Resolution: Schedule internal audits and allocate resources for prompt query management.

Starting early and leveraging expert guidance can streamline your pathway to market entry. Contact us today to discuss your specific requirements and let us help you secure your CDSCO license efficiently.

Navigating the CDSCO licensing process for your Microwave Hyperthermia System Catheter need not be daunting. With expert support, clear planning, and thorough documentation, your medical device can reach Indian patients safely and compliantly.