CDSCO License for Cryosurgical unit and accessories
Medical Device Information
Intended Use
A cryosurgical unit with a liquid nitrogen cooled cryoprobe and accessories is a device intended to destroy tissue during surgical procedures by applying extreme cold.
Comprehensive Guide to CDSCO Licensing for Cryosurgical Units and Accessories (Class B Medical Devices)
Cryosurgical units with liquid nitrogen-cooled cryoprobes and their accessories play a critical role in dermatological and plastic surgery by enabling precise tissue destruction through extreme cold application. Given their specialized use and moderate risk classification, regulatory compliance with the Central Drugs Standard Control Organization (CDSCO) in India is essential for manufacturers and importers aiming to market these devices.
With over 25 years of experience assisting 500+ companies in navigating the CDSCO licensing ecosystem, we provide a detailed, practical roadmap tailored specifically for Class B cryosurgical units as per Notification 29/Misc./03/2020-DC (147), dated 26.7.2021.
CDSCO Regulatory Framework for Cryosurgical Units
Cryosurgical units fall under the regulatory scope of medical devices governed by the Medical Devices Rules, 2017, enacted by CDSCO. These rules ensure that devices meet safety, quality, and performance standards before entering the Indian market. For a Class B device like cryosurgical units, the licensing process involves both product testing and manufacturing site audits to confirm compliance.
Understanding the CDSCO MD Online Portal is crucial as it is the primary platform for all license applications, fee submissions, and status tracking.
Risk Classification and License Requirements for Cryosurgical Units
Cryosurgical units are classified as Class B devices under the Medical Device Rules, aligning with their moderate risk profile. This classification requires manufacturers to obtain an MD5 Manufacturing License from the State Licensing Authority.
Key points:
- License Form: MD3 (application for MD5 license)
- Authority: State Licensing Authority
- Process Duration: Approximately 3-4 months (including test license and audit)
- Fees: INR 5,000 per application + INR 500 per product
For detailed classification criteria, manufacturers can refer to the Medical Device Classification guide.
MD5 Manufacturing License Process for Cryosurgical Units
The MD5 license process is comprehensive and involves multiple stages:
Test License Application (Form MD13): Initially, you must apply for a test license to manufacture and test the cryosurgical unit. This step typically takes 1.5 to 2 months.
Product Testing: After obtaining the test license, the cryosurgical unit must be tested at a CDSCO-approved government testing laboratory to ensure compliance with performance and safety standards. Refer to the Testing Laboratories list for accredited labs.
Document Preparation: Prepare exhaustive documentation, including the Device Master File, Plant Master File, risk management files, and other technical files.
License Application (Form MD3): Submit your MD5 license application with all supporting documents through the CDSCO MD Online Portal.
Audit by Notified Body: Your manufacturing site will undergo an audit by a CDSCO-notified body to verify compliance with quality management systems and manufacturing standards. You can check the list of notified bodies authorized for audits.
Query Resolution: Address any queries raised by the licensing authority or notified body promptly.
Grant of License: Upon satisfactory audit and documentation review, the MD5 manufacturing license is issued on Form MD5.
For a detailed walkthrough, our MD5 License Guide offers practical insights.
Comprehensive List of Documents Required for MD5 License
To avoid delays, prepare the following documents meticulously:
- Company Constitution (Incorporation Certificate/Partnership Deed)
- Proof of Ownership or Lease of Manufacturing Premises
- Qualification and Experience Certificates of Technical Staff
- Fire No Objection Certificate (NOC)
- Pollution Control Board NOC
- Device Master File (DMF): Detailed technical description, manufacturing process, and specifications (See DMF Guide)
- Plant Master File (PMF): Factory layout, equipment details, quality control systems (See PMF Guide)
- Essential Principles Compliance Checklist
- Risk Management File detailing hazard analysis and mitigation (Risk Management Best Practices)
- Test Reports from CDSCO-approved labs
- Product Labels and Instructions for Use (IFU)
- Quality Management System (QMS) Documents, preferably ISO 13485:2016 certification
Ensuring completeness and accuracy of these documents significantly reduces processing delays.
Import License Process (MD15) for Cryosurgical Units
For importers, obtaining an MD15 Import License from the Central Licensing Authority is mandatory before marketing cryosurgical units in India.
Key steps:
- Prepare all requisite documents including manufacturing license from the country of origin, free sale certificate, ISO 13485:2016, CE certificate, device and plant master files, and wholesale license.
- Submit Form MD14 for the import license application through the CDSCO portal.
- Respond to any queries from the CDSCO within stipulated timelines.
- Await license issuance on Form MD15, typically within 5-6 months.
For the complete process, refer to our detailed Import License Guide.
Timeline and Processing Duration
| Process Step | Duration |
|---|---|
| Test License (MD13) | 1.5 - 2 months |
| Product Testing | 2 - 4 weeks |
| Documentation Preparation | 2 - 4 weeks |
| MD5 License Application | After test license and testing |
| Audit by Notified Body | 4 - 6 weeks |
| Query Resolution | 2 - 4 weeks |
| Total Time | 3 - 4 months |
Planning accordingly and starting documentation early can expedite your market entry.
Government Fees and Costs
For manufacturing cryosurgical units (Class B):
- Application Fee: INR 5,000 per application
- Product Fee: INR 500 per product
Additional costs may include testing fees at approved labs, audit fees charged by notified bodies, and consultancy fees if external assistance is employed.
Common Challenges and Practical Solutions
1. Incomplete Documentation: Missing or inconsistent documents cause the most delays. Use detailed checklists and cross-verify documents against CDSCO requirements.
2. Delays in Product Testing: Testing labs may have backlogs. Schedule testing early and choose labs with proven turnaround times.
3. Audit Non-Compliance: Unprepared quality management systems or facilities can cause audit failures. Conduct internal audits and mock inspections before the notified body audit.
4. Query Management: Slow response to CDSCO queries can stall the process. Assign dedicated personnel for timely and comprehensive replies.
Expert Consultation and Support
Navigating CDSCO licensing for cryosurgical units is complex but manageable with expert guidance. Our team’s extensive experience in securing over 500 successful licenses means we understand the nuances of regulatory expectations, documentation standards, and audit preparation.
We offer tailored consulting services including DMF and PMF preparation, risk management implementation, audit readiness, and liaison with CDSCO authorities to streamline your licensing journey.
Getting Started with Your CDSCO License Application for Cryosurgical Units
- Assess Your Device Classification: Confirm Class B status as per CDSCO guidelines.
- Register on the CDSCO MD Online Portal: Begin your application process here.
- Prepare Documentation: Initiate Device Master File and Plant Master File compilation.
- Apply for Test License (Form MD13): Secure preliminary approval to manufacture and test.
- Plan Product Testing: Book slots at CDSCO-approved labs early.
- Schedule Notified Body Audit: Identify a notified body from the official list and prepare accordingly.
- Submit MD5 License Application: After successful testing and documentation.
Starting early and following a stepwise approach minimizes surprises and accelerates your path to market.
If you are ready to embark on your regulatory journey for cryosurgical units or need personalized support, contact us to leverage our 25+ years of CDSCO licensing expertise.
Together, we can ensure your medical devices meet India’s stringent regulatory standards for safety and efficacy, enabling you to serve healthcare professionals and patients reliably and compliantly.
