CDSCO License for Penile extracorporeal shock wave therapy system
Medical Device Information
Intended Use
A mobile assembly of devices designed to provide spark-gap-generated, low-intensity, extracorporeal shock wave therapy to treat erectile dysfunction (ED) [impotence] to rehabilitate penile erection and rigidity adequate for intercourse.
Comprehensive Guide to CDSCO Licensing for Penile Extracorporeal Shock Wave Therapy System (Class B Medical Device)
The penile extracorporeal shock wave therapy system is a specialized urology device designed to deliver spark-gap-generated, low-intensity shock waves to treat erectile dysfunction (ED). This mobile assembly rehabilitates penile erection and rigidity to enable adequate intercourse. Given its therapeutic role and electrical components, this device is classified as a Class B medical device under the CDSCO regulatory framework, requiring a thorough licensing process to ensure safety, efficacy, and compliance before entering the Indian market.
CDSCO Regulatory Framework for Penile Extracorporeal Shock Wave Therapy Systems
The Central Drugs Standard Control Organization (CDSCO) governs medical device regulation in India, mandating licenses based on device classification. For Class B devices such as penile shock wave therapy systems, the licensing authority is the State Licensing Authority, and the applicable license type is the MD5 manufacturing license.
The device falls under the urology category and was officially notified under File No. 29/Misc./03/2020-DC (145) on 23.8.2021. This notification mandates compliance with the Medical Device Rules, 2017, and subsequent amendments.
Risk Classification and License Requirements
Class B devices represent low to moderate risk. According to CDSCO guidelines, manufacturers of Class B devices must obtain an MD5 license (Application Form MD3) granted by the State Licensing Authority. The MD5 license process is comprehensive, involving a test license, product testing, document submission, and audit by a notified body.
For penile extracorporeal shock wave therapy systems, this means:
- License Type: MD5 (Manufacturing License for Class B devices)
- Authority: State Licensing Authority
- Total Timeline: Approximately 3-4 months
- Cost: Rs 5,000 per application + Rs 500 per product
Manufacturing License Process (MD5)
The MD5 license process is multi-step and designed to ensure product safety and manufacturing quality:
- Test License (Form MD13): Apply first for a test license which allows limited manufacturing to obtain test samples. This stage takes about 1.5 to 2 months.
- Product Testing: Submit device samples to CDSCO-approved government testing laboratories. Testing assesses conformity to applicable standards. See the official list of testing laboratories.
- Document Preparation: Compile essential documentation including Device Master File, Plant Master File, risk management file, and quality management system documents.
- Application Submission (Form MD3): Submit the manufacturing license application through the CDSCO MD Online Portal.
- Audit by Notified Body: A notified body conducts a mandatory audit of manufacturing facilities and QMS. Refer to the list of notified bodies for selecting an auditor.
- Query Resolution: Address any queries from the notified body or CDSCO inspectors promptly.
- License Grant (Form MD5): Upon successful compliance, the State Licensing Authority issues the MD5 manufacturing license.
Manufacturing License Documents Required
To expedite approval, manufacturers should prepare the following comprehensive documents:
- Company Constitution (Incorporation Certificate, Memorandum & Articles of Association)
- Proof of Ownership or Lease of Manufacturing Premises
- Details and Qualifications of Technical Staff
- Fire NOC and Pollution Control NOC
- Device Master File (DMF): Detailed device design, specifications, and manufacturing process documentation. Our Device Master File guide offers valuable insights.
- Plant Master File (PMF): Manufacturing site layout, equipment details, and quality assurance procedures. See our Plant Master File guide.
- Essential Principles Checklist confirming compliance with Indian regulations
- Risk Management File detailing hazard analysis and mitigation measures. Learn more about implementing risk management.
- Product Test Reports from CDSCO-approved labs
- Labels and Instructions for Use (IFU) compliant with Indian labeling norms
- Quality Management System (QMS) documentation, preferably ISO 13485:2016 certification
Import License Process (MD15) for Penile Shock Wave Therapy Systems
Importers wishing to bring this device into India must obtain an MD15 import license from the Central Licensing Authority. The MD15 license process is slightly different:
- Application Form: MD14
- Timeline: Approximately 5-6 months
- Documents: Manufacturing license from country of origin, Free Sale Certificate, ISO 13485:2016, CE Certificate, Device and Plant Master Files, Wholesale License, Company Constitution
- Fees: Varies by risk class; for Class B devices, Rs 2,000 per site and Rs 1,000 per product
The application is also submitted via the CDSCO MD Online Portal.
Timeline and Processing Duration
| Stage | Duration |
|---|---|
| Test License (MD13) | 1.5 - 2 months |
| Product Testing | 3 - 4 weeks |
| Document Preparation | 2 - 3 weeks |
| MD5 Application & Audit | 1 - 1.5 months |
| Query Resolution | 2 - 3 weeks |
| Total Time | ~3 to 4 months |
Timelines can vary based on completeness and accuracy of documentation, laboratory testing backlog, and audit scheduling.
Government Fees and Costs
- Test License (MD13): Typically included with subsequent application
- MD5 Manufacturing License Application Fee: Rs 5,000
- Product Fee: Rs 500 per product
- Notified Body Audit Charges: Additional, varies by auditor
- Testing Laboratory Charges: Approx Rs 50,000 to Rs 1,00,000 depending on test scope
Budgeting for these costs upfront is crucial to avoid delays.
Common Challenges and Solutions
Challenge: Delays in product testing due to limited capacity at government labs.
- Solution: Plan sample submission early and consider private accredited labs if permitted.
Challenge: Incomplete documentation leading to audit queries.
- Solution: Engage experienced regulatory consultants to pre-audit document packages.
Challenge: Coordinating timely audit visits with notified bodies.
- Solution: Book audit dates well in advance and maintain open communication with auditors.
Challenge: Understanding technical requirements for Device and Plant Master Files.
- Solution: Utilize detailed guides such as our Device Master File guide and Plant Master File guide.
Expert Consultation and Support
With over 25 years of experience and 500+ successful CDSCO license applications, we provide end-to-end support tailored to penile extracorporeal shock wave therapy systems. Our services include:
- Gap analysis of current documentation
- Preparation of DMF, PMF, and risk management files
- Coordination with testing laboratories and notified bodies
- Application submission and query resolution
- Training on quality management compliance
Partnering with regulatory experts significantly enhances your chances of timely approval and market entry.
Getting Started with Your CDSCO License Application
To initiate your licensing journey for the penile extracorporeal shock wave therapy system:
- Assess Classification: Confirm Class B status and understand applicable regulations.
- Register on the CDSCO MD Online Portal: Create your account at the official portal to access application forms.
- Apply for Test License (MD13): Prepare and submit your test license application.
- Arrange Product Testing: Coordinate with CDSCO-approved labs for sample testing.
- Prepare Documentation: Compile all required files, leveraging our expert guides.
- Select Notified Body: Choose an accredited auditor from the list of notified bodies and schedule your audit.
- Submit MD5 Application (Form MD3): Complete and file the manufacturing license application.
- Respond to Queries: Promptly address any requests from CDSCO or notified body.
- Obtain MD5 License: Once approved, commence regulated manufacturing and sales in India.
Navigating CDSCO licensing for specialized devices like penile extracorporeal shock wave therapy systems can be complex. Our seasoned regulatory consultancy ensures your compliance journey is smooth, efficient, and successful. Contact us today to discuss your project and secure your license with confidence.
