CDSCO License for Activated-oxygen generator

Introduction to Activated-Oxygen Generator and CDSCO Licensing

The Activated-oxygen generator is a vital respiratory medical device designed to produce activated oxygen (singlet oxygen) mixed with room air, generating activated water as a by-product. Such devices have increasing applications in therapeutic and sterilization contexts, making them essential in healthcare settings. Given their intended use and risk profile, they fall under Class B risk classification according to CDSCO regulations, mandating stringent compliance to ensure safety and efficacy.

Navigating the regulatory pathway with India’s Central Drugs Standard Control Organization (CDSCO) is crucial for manufacturers and importers aiming to market the Activated-oxygen generator in India. With over 25 years of experience assisting 500+ companies, we offer a detailed walkthrough of the CDSCO licensing process tailored specifically for this device category.

CDSCO Regulatory Framework for Activated-Oxygen Generators

The CDSCO classifies medical devices into four risk classes (A, B, C, D) based on their potential risk to users. Devices like the Activated-oxygen generator, classified as Class B, require a manufacturing license (MD5) from the State Licensing Authority and adherence to regulatory standards outlined in the Medical Device Rules, 2017.

The notified file number for this device, 29/Misc/03/2020-DC(197), dated 6.8.2021, confirms its inclusion under respiratory device regulations.

Risk Classification and License Requirements

• Risk Class: B
• License Type: MD5 (Manufacturing License for Class A and B devices)
• Regulatory Authority: State Licensing Authority
• Required Approvals: Test license (MD13), product testing at CDSCO-approved labs, audit by notified body

Given the device’s classification, manufacturers must comply with a comprehensive regulatory pathway to gain license approval.

Manufacturing License Process for Activated-Oxygen Generators (MD5)

The MD5 license process involves multiple steps designed to ensure product safety and manufacturing quality:

1. Apply for Test License (Form MD13): Initiate the process by applying for a test license allowing product testing. This stage typically takes 1.5 to 2 months.
2. Product Testing: Conduct testing of the activated-oxygen generator at CDSCO-approved laboratories to generate compliance test reports.
3. Document Preparation: Collate required documents including Device Master File (DMF), Plant Master File (PMF), and quality system records.
4. Application Submission (Form MD3): Submit the manufacturing license application via the CDSCO MD Online Portal along with fees.
5. Audit by Notified Body: A notified body conducts an on-site audit of the manufacturing facility to verify compliance. Refer to the list of notified bodies for authorized auditors.
6. Respond to Queries: Address any queries or clarifications raised by CDSCO or the notified body.
7. Grant of License (Form MD5): Upon successful review and audit, the manufacturing license is granted.

Manufacturing License Documents Required for Activated-Oxygen Generators

• Company constitution documents (incorporation certificate, partnership deed, etc.)
• Proof of ownership or lease agreement of manufacturing premises
• Details and qualification certificates of technical staff
• Fire safety and pollution control NOCs
• Device Master File (DMF) detailing design, specifications, and risk management (Device Master File Guide)
• Plant Master File (PMF) covering facility layout, equipment, and quality systems (Plant Master File Guide)
• Essential Principles Checklist confirming conformity with regulatory standards
• Risk Management File demonstrating hazard analysis and mitigation (Risk Management)
• Test reports from CDSCO-approved labs (Testing Laboratories)
• Labeling samples and Instructions for Use (IFU)
• Quality Management System (QMS) documents, typically ISO 13485:2016 certification

Import License Process for Activated-Oxygen Generators (MD15)

For importers bringing Activated-oxygen generators into India, an MD15 import license issued by the Central Licensing Authority is mandatory. The process includes:

• Document preparation including manufacturing license, Free Sale Certificate, ISO 13485:2016, CE certificate, DMF, PMF, and wholesale license
• Submission of application via the CDSCO MD Online Portal
• Resolution of any queries from CDSCO
• Grant of MD15 import license

The process typically takes 5-6 months. Unlike manufacturing licenses, no test license (MD13) is required for imports.

Import License Documents Required

• Valid manufacturing license from the country of origin
• Free Sale Certificate
• ISO 13485:2016 certification
• CE Mark certificate (if applicable)
• Device Master File and Plant Master File
• Wholesale drug license (if applicable)
• Company's constitutional documents

Timeline and Processing Duration

For the Activated-oxygen generator (Class B), expect the full manufacturing license process to span approximately 3-4 months after obtaining the test license.

Government Fees and Costs

• MD5 License Fees:

  • Application fee: Rs 5000 per application
  • Product fee: Rs 500 per product (per device model)

• Test License (MD13) Fees: Variable depending on state authority

• Import License (MD15) Fees (for reference):

  • Class B: $2000 per site +$1000 per product

Budgeting for notified body audits, testing fees at CDSCO-approved labs, and document preparation costs is essential. Our experience indicates that thorough preparation minimizes additional costs from re-submissions or audit deficiencies.

Common Challenges and Practical Solutions

• Delayed Test Reports: Testing at government-approved laboratories can sometimes face backlogs. Early scheduling and selecting less busy labs help mitigate delays.
• Incomplete Documentation: Missing or inadequate DMF or PMF details are frequent causes for audit queries. Using comprehensive templates and checklists ensures completeness.
• Notified Body Audit Non-Compliance: Non-adherence to QMS or facility standards can lead to audit failures. Pre-audit gap assessments and mock audits significantly improve success rates.
• Query Resolution Delays: Prompt and detailed responses to CDSCO’s queries help avoid prolonged processing times.

Our clients have successfully overcome these hurdles by leveraging expert consultation and adhering to structured project timelines.

Expert Consultation and Support

With over 25 years of regulatory consulting expertise, we have guided over 500 companies through the CDSCO licensing maze for respiratory devices including the Activated-oxygen generator. Our services include:

• Comprehensive gap analysis and document preparation
• Coordination with notified bodies and testing laboratories
• Application submission and follow-up
• Training on regulatory compliance and QMS implementation

Partnering with experienced consultants accelerates approval timelines and ensures compliance with evolving regulatory requirements.

Getting Started with Your CDSCO License Application

For manufacturers of Activated-oxygen generators intent on entering the Indian market, begin by:

1. Registering on the CDSCO MD Online Portal: Create your account and familiarize yourself with application workflows.
2. Initiating Test License Application (MD13): Prepare and submit initial application documents to commence product testing.
3. Engaging a Notified Body Early: Identify and communicate with a notified body from the official list to schedule audits.
4. Preparing Complete Documentation: Leverage our Device Master File Guide and Plant Master File Guide to ensure regulatory compliance.
5. Planning Timelines and Budgets: Allocate resources for testing, audits, and regulatory fees based on the outlined timelines.

Taking these practical steps will position your Activated-oxygen generator for timely CDSCO approval, enabling successful market entry into India’s rapidly expanding medical device sector.

For detailed assistance and tailored support, contact us to leverage our regulatory expertise and proven track record in CDSCO licensing.

References:

• CDSCO MD Online Portal
• Notified Bodies List
• Testing Laboratories
• Device Master File Guide
• Plant Master File Guide
• Medical Device Classification
• Risk Management