CDSCO License for Pulmonary resuscitator

Introduction to Pulmonary Resuscitator and Regulatory Importance

Pulmonary resuscitators are vital anesthesiology devices designed to assist or provide ventilation to patients who are apnoeic or have inadequate respiration. Given the critical function of these hand-operated devices, regulatory compliance in India is stringent to ensure safety and effectiveness. Navigating the Central Drugs Standard Control Organization (CDSCO) licensing process is crucial for manufacturers and importers aiming to enter the Indian market.

With over 25 years of experience and having assisted more than 500 companies, we understand the complexities involved in securing CDSCO licenses for Class C medical devices like pulmonary resuscitators. This guide offers a comprehensive overview including regulatory framework, license types, documentation, timelines, costs, and practical advice tailored specifically for this device.

CDSCO Regulatory Framework for Pulmonary Resuscitators

Pulmonary resuscitators fall under the anesthesiology category and are classified as Class C devices due to their moderate to high risk potential. The regulatory framework mandates compliance with the Medical Device Rules (MDR) 2017 and subsequent amendments, including notification number 29/Misc/03/2020-DC(177) dated 12.07.2021.

Manufacturers and importers must obtain the appropriate CDSCO licenses before marketing these devices in India. For Class C devices, the central licensing authority governs the licensing process, ensuring rigorous evaluation including audits, testing, and documentation review.

Risk Classification and License Requirements for Class C Devices

The CDSCO classifies medical devices into four risk classes: A, B, C, and D. Pulmonary resuscitators are Class C devices, indicating a moderate to high risk. This classification determines the type of license required:

• Manufacturing License: MD9 (Application Form MD7) granted by the Central Licensing Authority.
• Import License: MD15 (Application Form MD14) also issued by the Central Licensing Authority.

Class C devices undergo stringent scrutiny including mandatory testing in government-approved labs and audits by CDSCO inspectors to ensure conformity with Indian and international safety standards.

Manufacturing License Process (MD9) for Pulmonary Resuscitators

Step 1: Obtain Test License (Form MD13)

Before applying for the MD9 license, manufacturers must acquire a test license on Form MD13. This license allows manufacturing a limited quantity of the device for sample testing.

• Timeline: Approximately 1.5 to 2 months.
• Purpose: To enable product testing at CDSCO-approved laboratories.

Step 2: Product Testing

Testing must be conducted at government-approved laboratories listed on the CDSCO Testing Laboratories portal. The tests verify compliance with standards such as ISO 80601-2-12 (specific to pulmonary devices).

• Testing Duration: 4-6 weeks depending on lab workload.

Step 3: Documentation Preparation

Prepare comprehensive documentation including Device Master File (DMF), Plant Master File (PMF), Quality Management System (QMS) certificates, Risk Management file, and others detailed below.

Step 4: Application Submission

Submit the MD9 application (Form MD7) through the CDSCO MD Online Portal. Ensure all documents are complete and fees paid.

Step 5: CDSCO Audit

After document verification, CDSCO inspectors conduct a physical audit of manufacturing facilities and quality systems.

Step 6: Query Resolution

Respond promptly to queries raised by CDSCO or the audit team to avoid delays.

Step 7: Grant of Manufacturing License

Upon satisfactory audit and document review, CDSCO issues the MD9 manufacturing license.

• Total Process Duration: Approximately 4 to 5 months after test license.

For detailed guidance, refer to our MD9 License Guide.

Manufacturing License Documents Required for Pulmonary Resuscitators

1. Company Constitution and Registration Certificates
2. Proof of Ownership or Lease of Manufacturing Premises
3. Technical Staff Qualification and Experience Documents
4. Fire NOC and Pollution Control Board NOC
5. Device Master File (DMF) – design, specifications, manufacturing SOPs (DMF Guide)
6. Plant Master File (PMF) – infrastructure, equipment, and facility control (PMF Guide)
7. Essential Principles Checklist confirming compliance with applicable standards
8. Risk Management File documenting hazard analysis and mitigation (Risk Management Guide)
9. Test Reports from CDSCO-approved labs
10. Product Labels and Instructions for Use (IFU)
11. Quality Management System Certificates (ISO 13485:2016 preferred)

Ensuring these documents are precise and aligned with CDSCO requirements significantly reduces processing delays.

Import License Process (MD15) for Pulmonary Resuscitators

Importers seeking to bring pulmonary resuscitators into India must obtain an MD15 import license from the Central Licensing Authority.

Key Steps:

• Prepare mandatory documents including manufacturing license from the country of origin, Free Sale Certificate, CE Certificate, Device and Plant Master Files.
• Submit application on Form MD14 via the CDSCO MD Online Portal.
• Respond to any departmental queries.
• Obtain import license in Form MD15.

Timeline:

• Typically takes 5 to 6 months from submission to grant.

For a comprehensive overview, consult our Import License Guide.

Import License Documents Required

1. Manufacturing License from country of origin
2. Free Sale Certificate
3. ISO 13485:2016 Certification
4. CE Certificate or equivalent regulatory approval
5. Device Master File and Plant Master File
6. Wholesale License (if applicable)
7. Company Constitution and Registration Proof
8. Product Labeling and IFU

Timeline and Processing Duration

Planning for a total of 6-7 months for manufacturing and 5-6 months for import licensing is prudent. Early preparation of documents and prompt query responses can expedite these timelines.

Government Fees and Costs

Additional costs include product testing fees at approved labs and fees for audits by notified bodies or CDSCO inspectors.

Common Challenges and Solutions

Challenge 1: Delays in Product Testing

Solution: Engage with CDSCO-approved labs early; pre-book testing slots and ensure samples meet submission criteria.

Challenge 2: Incomplete Documentation

Solution: Use detailed checklists and templates for DMF, PMF, and Risk Management files; consider professional consultancy support.

Challenge 3: Audit Non-Compliance

Solution: Conduct internal pre-audit reviews; ensure QMS and manufacturing practices align with ISO 13485 and CDSCO expectations.

Challenge 4: Query Resolution Delays

Solution: Assign dedicated regulatory personnel for rapid response; maintain clear communication with CDSCO officials.

Expert Consultation and Support

Navigating CDSCO licensing for Class C devices like pulmonary resuscitators requires expertise. Our 25+ years’ experience and 500+ successful client engagements position us uniquely to assist manufacturers and importers with:

• End-to-end license application management
• Documentation preparation and review
• Pre-audit readiness and training
• Regulatory strategy tailored to your device

Partnering with experts mitigates risks of rejection and accelerates market entry.

Getting Started with Your CDSCO License Application

1. Classify Your Device Accurately: Verify that your pulmonary resuscitator is Class C per Medical Device Classification.

2. Prepare Your Test License Application: Submit Form MD13 on the CDSCO MD Online Portal to commence testing.

3. Engage a CDSCO-Approved Testing Laboratory: Select a lab early from the official list to avoid delays.

4. Compile Required Documentation: Use our Device Master File and Plant Master File guides to streamline preparation.

5. Plan for Audits: Schedule internal audits and train your team in CDSCO compliance.

6. Apply for MD9 Manufacturing License: After successful testing, submit Form MD7 via the online portal.

7. For Importers, Prepare MD15 Application: Gather import-specific documents and apply through the same online portal.

Starting early and following a structured approach ensures your pulmonary resuscitator reaches Indian patients safely and legally. For personalized assistance, reach out to our regulatory experts to guide you every step of the way.