CDSCO License for Sterilization process indicator (Physical/chemical)
Medical Device Information
Intended Use
A physical/chemical sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor one or more parameters of the sterilization process on medical device.
Comprehensive Guide to CDSCO Licensing for Sterilization Process Indicators (Physical/Chemical) - Risk Class B
Sterilization process indicators (physical/chemical) play a critical role in healthcare by ensuring effective sterilization of medical devices. These indicators monitor sterilization parameters, providing healthcare providers with assurance that sterilization cycles meet required standards. As a Class B medical device under the CDSCO framework, these devices require a manufacturing license (MD5) before entering the Indian market. With over 25 years of experience assisting 500+ companies, we provide you with a detailed, practical roadmap to secure your CDSCO license efficiently.
CDSCO Regulatory Framework for Sterilization Process Indicators
The Central Drugs Standard Control Organization (CDSCO) regulates medical devices in India under the Medical Device Rules, 2017. Sterilization process indicators fall under the notified category "General Hospital or Orthopaedic Instruments" as per Notification No. 29/Misc./03/2020-DC (193)- Part-3 dated 16.03.2022.
As a Class B device, the manufacturing license is granted by the State Licensing Authority through the MD5 license process. This regulatory pathway ensures compliance with safety, quality, and performance standards before market entry.
Risk Classification and License Requirements for Sterilization Process Indicators
Under India's risk-based classification system:
- Class A & B devices: Low to moderate risk, requiring an MD5 manufacturing license.
- Sterilization process indicators are categorized as Class B, requiring:
- MD5 License (manufacturing)
- Test License (MD13) for initial product testing
Understanding this classification is vital for adhering to the correct regulatory process and avoiding delays or compliance issues. For an in-depth classification review, visit our Medical Device Classification resource.
Manufacturing License Process (MD5) for Class B Devices
The MD5 license process for sterilization process indicators involves several sequential steps:
Obtain Test License (Form MD13): Apply to the State Licensing Authority to manufacture the device for testing purposes. This license is valid for 12 months and takes approximately 1.5 to 2 months to obtain.
Product Testing: Get your sterilization indicators tested at CDSCO-approved laboratories. Testing validates compliance with essential principles and standards. Refer to the list of testing laboratories for authorized facilities.
Document Preparation: Compile comprehensive technical documentation, including Device Master File (DMF), Plant Master File (PMF), Essential Principles Checklist, Risk Management File, and Quality Management System (QMS) documents.
Apply for Manufacturing License (Form MD3): Submit your application online via the CDSCO MD Online Portal.
Audit by Notified Body: A notified body conducts an on-site audit of your manufacturing facility and quality systems to verify compliance.
Respond to Queries: Address any queries or deficiencies raised by the licensing authority or notified body promptly.
Grant of MD5 License (Form MD5): Upon successful audit and document review, the State Licensing Authority issues the manufacturing license.
This entire process typically takes 3 to 4 months, assuming timely submissions and no major observations.
Manufacturing License Documents Required for Sterilization Process Indicators
To facilitate a smooth license approval, prepare the following key documents:
- Company Constitution: Incorporation certificate, partnership deed, or LLP agreement.
- Proof of Premises Ownership or Lease Agreement: Valid documentation verifying manufacturing site.
- Technical Staff Details: Qualification and experience certificates of key personnel.
- NOCs: Fire safety and pollution control certificates.
- Device Master File (DMF): Detailed device description, design, manufacturing process, and specifications. Our Device Master File guide offers practical tips.
- Plant Master File (PMF): Details of manufacturing facilities, equipment, and infrastructure. For easy preparation, see our Plant Master File guide.
- Essential Principles Checklist: Demonstrating compliance with Indian Medical Device Rules.
- Risk Management File: Hazard analysis and mitigation strategies compliant with ISO 14971. Visit our Risk Management resource for implementation advice.
- Test Reports: Laboratory test certificates from CDSCO-approved labs.
- Labels and Instructions for Use (IFU): Sample labels and user manuals.
- QMS Documents: Quality manual, SOPs, CAPA records, and training logs.
Import License Process (MD15) for Sterilization Process Indicators
If you are an importer of sterilization process indicators, the MD15 import license is mandatory. The process includes:
- Document preparation including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016 certification, CE Mark (if applicable), DMF, PMF, and wholesale license.
- Application submission on the CDSCO MD Online Portal.
- Departmental review and query resolution.
- License grant on Form MD15.
The import license typically takes 5 to 6 months to process. For detailed guidance, refer to our Import License guide.
Timeline and Processing Duration
| Step | Duration |
|---|---|
| Test License (MD13) | 1.5 - 2 months |
| Product Testing | 3 - 4 weeks |
| Document Preparation | 2 - 3 weeks |
| MD5 License Application | 1 week |
| Audit by Notified Body | 3 - 4 weeks |
| Query Resolution & Final Grant | 2 - 3 weeks |
Total Estimated Time: 3 to 4 months
Government Fees and Costs
| License Type | Fee Structure |
|---|---|
| MD5 License Application | Rs 5,000 per application + Rs 500/product |
| Test License (MD13) | Included in application process |
Additional costs to consider:
- Laboratory testing fees (varies by lab and number of tests)
- Notified body audit fees
- Consultancy fees if opting for expert support
Common Challenges and Solutions
Challenge 1: Delays in Test License Approval
- Solution: Submit a complete, error-free application with all required documents upfront. Early engagement with the State Licensing Authority can expedite processing.
Challenge 2: Incomplete or Non-compliant Documentation
- Solution: Use checklists and templates for DMF, PMF, and risk files. Our guides and templates help streamline documentation.
Challenge 3: Audit Non-Conformities
- Solution: Conduct pre-audit internal assessments and staff training. Engage notified bodies early for clarifications.
Challenge 4: Query Resolution Delays
- Solution: Assign dedicated regulatory personnel to address queries promptly with detailed responses.
Expert Consultation and Support
Navigating CDSCO licensing can be complex. With over two decades of experience and a track record of 500+ successful licenses, we provide:
- Gap analysis of your current compliance status
- Customized documentation support
- Coordination with notified bodies and testing labs
- End-to-end application management
Our expert team stays updated on regulatory changes and ensures your sterilization process indicators meet all Indian requirements.
Getting Started with Your CDSCO License Application
- Assess your device classification: Confirm Class B status via CDSCO notifications.
- Prepare your test license application (MD13): Gather company and technical documents.
- Select a CDSCO-approved testing laboratory: Plan sample submission and testing timelines.
- Compile key documents: Use our Device Master File guide and Plant Master File guide for assistance.
- Register and submit applications via the CDSCO MD Online Portal.
- Schedule notified body audit: Refer to the Notified Bodies List.
Beginning with a clear roadmap and expert guidance ensures a smooth licensing journey for your sterilization process indicators. Reach out to our team to discuss your specific case and initiate the licensing process today.
