CDSCO License for Steam sterilizer.
Medical Device Information
Intended Use
A steam sterilizer (autoclave) is a device that is intended for use by a health care provider to sterilize medical devices by means of pressurized steam.
Comprehensive Guide to CDSCO Licensing for Steam Sterilizers (Class C Medical Device)
As seasoned regulatory consultants with over 25 years of experience, having assisted more than 500 companies in successfully navigating the CDSCO licensing process, we understand the critical importance of compliance for medical devices like steam sterilizers. Steam sterilizers, also known as autoclaves, are essential devices used by healthcare providers to sterilize medical instruments using pressurized steam. Classified as Class C devices under the CDSCO framework, steam sterilizers fall under the category of General Hospital or Orthopaedic Instruments with Notification 29/Misc./03/2020-DC (193)- Part-3 dated 16.03.2022.
CDSCO Regulatory Framework for Steam Sterilizers
The Central Drugs Standard Control Organization (CDSCO) regulates medical devices in India under the Medical Device Rules (MDR) 2017. Steam sterilizers being Class C devices are considered moderate to high-risk devices and hence require a manufacturing license (MD9) from the Central Licensing Authority. The regulatory framework ensures that the device meets safety, efficacy, and quality standards before entering the Indian market.
Risk Classification and License Requirements
According to the medical device classification under CDSCO MDR 2017, steam sterilizers are Class C devices, implying a higher risk profile. As such, manufacturers must obtain an MD9 manufacturing license (Form MD7) from the Central Licensing Authority.
| Device Name | Risk Class | License Type | Licensing Authority | Approx. Timeline | Government Fees |
|---|---|---|---|---|---|
| Steam Sterilizer | C | MD9 | Central Licensing Authority | 4-5 months | Rs 50,000 + Rs 1,000 per product |
Manufacturing License Process for Steam Sterilizers (MD9)
Obtaining the MD9 license involves a multi-step process:
Test License (Form MD13): Initially, the manufacturer must apply for a test license, which typically takes 1.5 to 2 months. This allows product testing in designated government-approved laboratories.
Product Testing: Testing must be conducted in notified labs to verify compliance with Indian and international standards.
Document Preparation: Prepare essential documents including Device Master File, Plant Master File, Risk Management File, and Quality Management System (QMS) documentation.
Application Submission (Form MD7): Submit the manufacturing license application through the CDSCO MD Online Portal.
Inspection Audit: CDSCO inspectors will conduct a thorough audit of manufacturing facilities and QMS.
Queries Resolution: Respond promptly to any queries raised by CDSCO or auditors to avoid delays.
License Grant (Form MD9): Upon satisfactory review and inspection, the MD9 manufacturing license is granted.
Manufacturing License Documents Required for Steam Sterilizers
For a successful MD9 application, the following documents must be meticulously prepared and submitted:
- Company constitution documents (e.g., Incorporation Certificate)
- Proof of ownership or lease of manufacturing premises
- Details and qualifications of technical staff
- Fire and Pollution NOCs
- Device Master File (DMF) detailing design, manufacturing processes, and specifications (Device Master File Guide)
- Plant Master File (PMF) outlining manufacturing facility and quality controls (Plant Master File Guide)
- Essential Principles Checklist demonstrating regulatory compliance
- Risk Management File documenting hazard analysis and mitigation (Risk Management)
- Product test reports from CDSCO-approved labs (Testing Laboratories)
- Labeling and Instructions For Use (IFU)
- Quality Management System (QMS) documents, preferably ISO 13485:2016 certified
Import License Process for Steam Sterilizers (MD15)
For importers, an MD15 import license is mandatory. The process, overseen by the Central Licensing Authority, generally spans 5-6 months. Unlike manufacturing licenses, a test license is not required prior to application. The steps include:
- Document preparation including manufacturing license from country of origin, Free Sale Certificate, CE certificate, and ISO 13485:2016 certification
- Application submission on the CDSCO MD Online Portal
- Addressing departmental queries
- License grant on Form MD15
Import License Documents Required
Key documents needed for import licensing include:
- Valid manufacturing license from the country of origin
- Free Sale Certificate
- ISO 13485:2016 certification
- CE Certificate or equivalent
- Device Master File
- Plant Master File
- Wholesale license
- Company constitution documents
Timeline and Processing Duration
| License Type | Processing Time |
|---|---|
| Test License (MD13) | 1.5 - 2 months |
| MD9 Manufacturing License | 4 - 5 months (including test license and audit) |
| MD15 Import License | 5 - 6 months |
Government Fees and Costs
| License Type | Application Fee | Per Product Fee |
|---|---|---|
| MD9 Manufacturing | Rs 50,000 | Rs 1,000 |
| MD15 Import | Class C: Rs 3,000/site | Rs 1,500/product |
Note: Additional costs include testing fees charged by notified laboratories and audit fees if engaging a notified body.
Common Challenges and Solutions
Challenge: Delays due to incomplete documentation or improper quality system implementation.
Solution: Engage with experienced consultants to ensure thorough documentation and compliance with ISO 13485 standards.
Challenge: Difficulty in sourcing timely test reports from government-approved labs.
Solution: Plan testing schedules in advance and consider alternative notified labs listed on the CDSCO portal.
Challenge: Non-compliance found during facility audit.
Solution: Conduct pre-audit internal assessments and remediate non-conformities before official inspection.
Expert Consultation and Support
Our extensive experience enables us to provide end-to-end support, from device classification and documentation preparation to liaison with CDSCO officials and notified bodies. We also offer assistance with:
- Preparation of Device and Plant Master Files
- Risk management implementation tailored for steam sterilizers
- Scheduling and managing product testing
- Navigating audit processes with notified bodies
Getting Started with Your CDSCO License Application
- Classify Your Device: Confirm the classification of your steam sterilizer as Class C.
- Prepare Documentation: Begin assembling all required documents, including Device Master File and Risk Management File.
- Apply for Test License: Submit Form MD13 through the CDSCO MD Online Portal to obtain a test license.
- Conduct Product Testing: Engage notified laboratories early to avoid bottlenecks.
- Apply for Manufacturing License: Post successful testing, submit Form MD7 application for MD9 license.
- Prepare for Audit: Ensure your manufacturing site and QMS meet CDSCO requirements.
- Respond to Queries Promptly: Expedite approval by addressing any departmental or audit queries without delay.
For importers, after ensuring all documentation and certifications are ready, apply for the MD15 import license via the same portal.
By following these practical steps and leveraging expert guidance, manufacturers and importers of steam sterilizers can confidently navigate the CDSCO licensing process and bring their products to the Indian healthcare market efficiently and compliantly.
