CDSCO License for Penile extracorporeal shock wave therapy system applicator

Introduction to Penile Extracorporeal Shock Wave Therapy System Applicator Licensing

The Penile Extracorporeal Shock Wave Therapy System Applicator is a specialized Class B medical device used in urology to treat erectile dysfunction (ED). This hand-held applicator transmits low-intensity shock waves generated electrohydraulically to the penile shaft and crura, aiming to rehabilitate penile erection and restore rigidity sufficient for intercourse. Given its therapeutic importance and patient safety considerations, regulatory compliance with the Central Drugs Standard Control Organization (CDSCO) is mandatory for manufacturers and importers targeting the Indian market.

With over 25 years of expertise and assisting 500+ companies, we understand the unique requirements and challenges involved in obtaining a CDSCO license for such devices. This guide offers detailed insights into the regulatory framework, documentation, timelines, and practical advice tailored specifically for this Class B urology device.

CDSCO Regulatory Framework for Penile Extracorporeal Shock Wave Therapy Applicator

The CDSCO regulates medical devices under the Medical Device Rules (MDR), 2017, which classify devices based on risk and intended use. The Penile Extracorporeal Shock Wave Therapy Applicator falls under Class B (low moderate risk), which dictates that the manufacturing license is granted by the State Licensing Authority through an MD5 license application (Form MD3). Import licenses for such devices come under Form MD15, issued by the Central Licensing Authority.

The device is listed under the urology category with the official notification File No. 29/Misc./03/2020-DC (145), dated 23.8.2021, confirming its classification and regulatory pathway.

Risk Classification and License Requirements

• Risk Class: B (Low Moderate Risk)
• Applicable License: MD5 Manufacturing License for Indian manufacturers
• Import License: MD15 License for importers

Class B devices require rigorous documentation, product testing, and audits before licensure.

Manufacturing License Process (MD5) for Class B Devices

Step 1: Obtain a Test License (Form MD13)

Before applying for the manufacturing license, manufacturers must secure a test license on Form MD13. This allows product testing in government-approved laboratories. The test license application typically takes 1.5 to 2 months to process.

Step 2: Product Testing

Testing must be conducted at CDSCO-approved labs to verify compliance with Indian standards. The list of government-approved testing laboratories can be accessed via the CDSCO Testing Laboratories list.

Step 3: Document Preparation

Prepare comprehensive documentation, including Device Master File (DMF) and Plant Master File (PMF), essential principles checklist, risk management file, and QMS records. Detailed guidance on preparing these documents can be found in our Device Master File Guide and Plant Master File Guide.

Step 4: Application Submission

Submit the manufacturing license application (Form MD3) via the CDSCO MD Online Portal, attaching all required documents.

Step 5: Notified Body Audit

An audit by a CDSCO-notified body is mandatory for MD5 license applications. You can check the list of authorized notified bodies on the Notified Bodies List.

Step 6: Query Resolution and License Grant

Respond promptly to any queries raised by the CDSCO or the notified body. Upon satisfactory compliance, the MD5 license is granted.

Manufacturing License Documents Required for Penile Extracorporeal Shock Wave Therapy Applicator

• Company Constitution and Registration Documents
• Proof of Ownership or Lease of Manufacturing Premises
• Qualification and Experience Details of Technical Staff
• Fire NOC and Pollution Control NOC
• Device Master File (DMF)
• Plant Master File (PMF)
• Essential Principles of Safety and Performance Checklist
• Risk Management File demonstrating compliance with standards
• Product Test Reports from CDSCO-approved labs
• Labels and Instructions for Use (IFU)
• Quality Management System (QMS) Documentation, preferably ISO 13485 certified

Import License Process (MD15) for Class B Devices

For importers, the MD15 license is mandatory. The process includes:

1. Document Preparation: Gather manufacturing license from country of origin, Free Sale Certificate, ISO 13485:2016 certification, CE Certificate, DMF, PMF, wholesale license, and company constitution.
2. Application Submission: Apply via the CDSCO MD Online Portal using Form MD14.
3. Query Resolution: Respond to departmental queries promptly.
4. License Issuance: Upon compliance, the MD15 license is granted, enabling legal import and distribution.

Import License Documents Required

• Manufacturing License from the country of origin
• Free Sale Certificate
• ISO 13485:2016 Certification
• CE Certificate for the device
• Device Master File
• Plant Master File
• Wholesale License for distribution
• Company Constitution and Registration Documents

Timeline and Processing Duration

Manufacturers can expect approximately 3 to 4 months for MD5 license completion, while importers should plan for 5 to 6 months for MD15.

Government Fees and Costs

• MD5 Manufacturing License:

  • Application Fee: INR 5,000 per application
  • Product Fee: INR 500 per product

• MD15 Import License:

  • For Class B devices: INR 2,000 per site + INR 1,000 per product

Additional costs include audit fees charged by notified bodies and testing fees payable to government-approved laboratories.

Common Challenges and Solutions

• Delayed Test Reports: Coordinate early with government-approved labs to schedule testing and avoid bottlenecks.
• Incomplete Documentation: Utilize checklists to ensure all files like DMF, PMF, risk management, and QMS documents are complete and up-to-date.
• Audit Non-Compliance: Engage experienced auditors and conduct internal pre-audits to ensure readiness.
• Query Management: Maintain a dedicated regulatory team to respond promptly and thoroughly to CDSCO queries.

Expert Consultation and Support

Navigating CDSCO licensing for specialized devices like the Penile Extracorporeal Shock Wave Therapy Applicator can be complex. Our regulatory consulting services include:

• Comprehensive gap analysis of your current compliance status
• Preparation and review of Device Master and Plant Master Files
• Coordination with notified bodies for audit scheduling
• Assistance with test license applications and liaising with testing labs
• End-to-end application submission and query management

Our proven track record with 500+ successful CDSCO licenses ensures your project advances smoothly and efficiently.

Getting Started with Your CDSCO License Application

1. Determine your role: Are you a manufacturer or importer? This dictates whether you apply for an MD5 or MD15 license.
2. Initiate test license application (MD13) if manufacturing: Submit your request early via the CDSCO MD Online Portal.
3. Compile required documentation: Utilize our detailed guides for Device Master File and Plant Master File preparation.
4. Schedule product testing: Contact CDSCO-approved labs in advance to secure testing slots.
5. Plan for notified body audit: Choose an authorized body from the Notified Bodies List and prepare your facility accordingly.
6. Submit application: Once testing and documentation are ready, submit your MD5 or MD15 license application online.
7. Prepare for queries: Assign a regulatory liaison to manage communications with CDSCO.

By following these actionable steps and leveraging our expert support, manufacturers and importers can confidently navigate the CDSCO licensing pathway for the Penile Extracorporeal Shock Wave Therapy System Applicator and successfully enter the Indian market.

For more detailed assistance, explore our comprehensive MD5 License Guide and Import License Guide to gain further insights specific to your licensing needs.