CDSCO License for Hydrogen Peroxide Gas Plasma Sterilization System

Comprehensive Guide to CDSCO Licensing for Hydrogen Peroxide Gas Plasma Sterilization Systems

Introduction: Understanding Your Device and Regulatory Importance

Hydrogen Peroxide Gas Plasma Sterilization Systems are critical medical devices used for sterilizing both metal and nonmetal/polymer-based instruments, primarily in general hospital and orthopedic settings. Given their role in infection control, ensuring compliance with CDSCO (Central Drugs Standard Control Organization) regulations is paramount for manufacturers and importers targeting the Indian market.

With Notification 29/Misc./03/2020-DC (193)- Part-3 dated 16.03.2022, these devices fall under Risk Class C, which demands rigorous evaluation and licensing by the CDSCO Central Licensing Authority. Navigating this process effectively can be challenging, but with over 25 years of experience and support for 500+ companies, we provide you precise, actionable insights to simplify your journey.

CDSCO Regulatory Framework for Hydrogen Peroxide Gas Plasma Sterilization Systems

The CDSCO classifies medical devices based on risk, with Class C representing moderate to high-risk devices. This classification mandates adherence to stringent licensing procedures to ensure safety, performance, and quality.

For Hydrogen Peroxide Gas Plasma Sterilization Systems, regulatory oversight ensures that the sterilization process meets international standards and safeguards patient safety across diverse healthcare applications. Compliance involves:

• Product testing by government-approved laboratories
• Submission of comprehensive technical documentation
• Facility audits by CDSCO or notified bodies

You must submit applications and track progress on the CDSCO MD Online Portal.

Risk Classification and License Requirements

Risk Class: C License Required: MD9 Manufacturing License (Application Form MD7)

Class C devices are centrally regulated by CDSCO, requiring a more complex application process than Class A or B devices. The MD9 license ensures that only manufacturers meeting rigorous quality and safety standards can produce such devices in India.

Manufacturing License Process (MD9) for Class C Devices

The MD9 licensing process generally spans 4-5 months and involves several critical stages:

1. Test License (Form MD13): Initiate with a test license application, which takes approximately 1.5 to 2 months. This license allows sample testing.

2. Product Testing: Conduct testing at government-approved laboratories listed on the CDSCO Testing Laboratories page to validate device safety and efficacy.

3. Document Preparation: Compile all necessary documentation, including Device Master File (DMF), Plant Master File (PMF), risk management files, and QMS documents.

4. MD9 License Application (Form MD7): Submit the application via the CDSCO MD Online Portal.

5. Audit: CDSCO inspectors conduct a thorough audit of manufacturing facilities and quality systems.

6. Queries and Clarifications: Address any queries raised by CDSCO during the review.

7. Grant of License: Upon satisfactory compliance, the MD9 license is issued.

For a detailed overview, refer to our MD9 License Guide.

Manufacturing License Documents Required

Prepare the following essential documents to ensure a smooth application:

• Company Constitution: Certificate of incorporation and registration
• Proof of Ownership or Lease of Premises: Valid documents demonstrating legal rights to the manufacturing site
• Technical Staff Details: Qualification and experience certificates of key personnel
• Fire NOC and Pollution Control NOC: Approvals from relevant authorities
• Device Master File (DMF): Comprehensive technical file detailing design, materials, and manufacturing processes; check our Device Master File guide
• Plant Master File (PMF): Documentation of facility layout, equipment, and quality systems; see our Plant Master File guide
• Essential Principles Checklist: Compliance with Indian medical device standards
• Risk Management File: Documented risk assessment and mitigation strategies; refer to our Risk Management guide
• Test Reports: Results from government-approved laboratory testing
• Labels and Instructions for Use (IFU): Device labeling and user manuals
• Quality Management System (QMS) Documents: ISO 13485 certification and associated SOPs

Import License Process (MD15) for Hydrogen Peroxide Gas Plasma Sterilization Systems

For importers, the MD15 license is mandatory, regulated centrally by CDSCO. This process typically takes 5-6 months and involves:

• Document Preparation: Including manufacturing license, free sale certificate, ISO 13485:2016, CE certificate, DMF, PMF, wholesale license, and company constitution.

• Application Submission: File Form MD14 through the CDSCO MD Online Portal.

• Queries and Review: Respond promptly to departmental requests.

• Grant of License: Issuance of MD15 import license.

Note that no test license is required for import applications.

For more, see our Import License Guide.

Import License Documents Required

• Manufacturing License of the product
• Free Sale Certificate from country of origin
• ISO 13485:2016 Certification
• CE Certificate or equivalent
• Device Master File and Plant Master File
• Wholesale License
• Company Constitution documents

Timeline and Processing Duration

Total time for MD9 license: Approximately 4-5 months.

Government Fees and Costs

• MD9 Manufacturing License: INR 50,000 per application
• Per Product Fee: INR 1,000
• Test License (MD13): Separate fees as applicable

For imports (MD15), fees vary by class and product count, generally higher for Class C devices.

Common Challenges and Solutions

• Delayed Documentation: Maintain a checklist and assign responsible personnel for timely document preparation.
• Testing Delays: Choose government-approved labs early; refer to the CDSCO Testing Laboratories list.
• Audit Non-Compliance: Conduct internal pre-audits and gap analyses before CDSCO inspections.
• Query Management: Prepare comprehensive responses and consult experts to avoid repeated queries.

Expert Consultation and Support

Our extensive experience with over 500 successful CDSCO license applications equips us to provide tailored guidance, from document preparation to audit readiness. We can assist in:

• Device classification and risk assessment
• Preparation of Device and Plant Master Files
• Coordinating with notified bodies and testing labs
• Managing regulatory submissions and follow-ups

Getting Started with Your CDSCO License Application

1. Assess Device Classification: Confirm your device is Class C via the Medical Device Classification resource.

2. Prepare Test License Application: Initiate Form MD13 for product samples.

3. Select Testing Laboratory: Choose from the list of government-approved labs early.

4. Compile Documentation: Utilize our Device and Plant Master File guides to streamline document creation.

5. Submit MD9 Application: Apply through the CDSCO MD Online Portal.

6. Prepare for Audit: Implement quality systems compliant with ISO 13485 and CDSCO requirements.

7. Engage Expert Support: Contact us to expedite your licensing process and avoid common pitfalls.

Embarking on your CDSCO licensing journey with a clear roadmap and expert support ensures a smoother, faster market entry for your Hydrogen Peroxide Gas Plasma Sterilization System. Reach out today to get started!