CDSCO License for Pulmonary function analysis system

Comprehensive Guide to CDSCO Licensing for Pulmonary Function Analysis Systems (Class B Respiratory Device)

As specialists with over 25 years of experience in medical device regulatory consulting, having supported 500+ companies across India, we understand the critical importance of securing the correct CDSCO license for your Pulmonary Function Analysis System. This respiratory device, classified as Class B under the CDSCO framework, requires careful adherence to regulatory mandates to ensure timely market entry and compliance.

CDSCO Regulatory Framework for Pulmonary Function Analysis Systems

The Central Drugs Standard Control Organization (CDSCO) governs the import, manufacture, and sale of medical devices in India. Pulmonary Function Analysis Systems, used to measure respiratory function in adults and compliant children, fall under the respiratory device category and are classified as Class B (low-moderate risk). This classification dictates the licensing pathway, documentation, and timelines.

Risk Classification and License Requirements

According to the CDSCO classification, Class B devices like the Pulmonary Function Analysis System require an MD5 manufacturing license if manufactured domestically and an MD15 import license if imported.

• Class B Risk: Low-moderate risk
• Regulatory Authority: State Licensing Authority for manufacturing (MD5 license)
• Application Form for Manufacturing: MD3 (for MD5 license)
• Import License Form: MD14 (for MD15 license)

For detailed device classification, you can refer to the Medical Device Classification guide.

Manufacturing License Process (MD5)

For manufacturers planning to produce the Pulmonary Function Analysis System in India, the MD5 license is mandatory.

Stepwise process:

1. Test License (Form MD13): Obtain a test license valid for 12 months to produce limited units for testing.
2. Product Testing: Conduct mandatory testing at CDSCO-approved laboratories. Refer to the list of testing laboratories.
3. Document Preparation: Compile essential documents including Device Master File, Plant Master File, Risk Management File, and QMS documents.
4. Application Submission: Submit the application on the CDSCO MD Online Portal using Form MD3.
5. Audit by Notified Body: Arrange for an audit by a notified body listed here: Notified Bodies List.
6. Resolution of Queries: Address any queries raised by the State Licensing Authority or the notified body.
7. Grant of License: Upon successful audit and document verification, the MD5 license (Form MD5) will be issued.

Manufacturing License Documents Required

To ensure a smooth application, prepare the following documents:

• Company Constitution (Incorporation Certificate, MOA/AOA)
• Proof of premises ownership or lease agreement
• Details and qualifications of technical staff
• Fire NOC and Pollution Control Board NOC
• Device Master File (DMF) – detailing design, specifications, and manufacturing process (Device Master File Guide)
• Plant Master File (PMF) – describing the manufacturing facility and quality systems (Plant Master File Guide)
• Essential Principles Compliance Checklist
• Risk Management File demonstrating compliance with ISO 14971 (Risk Management Guide)
• Product Test Reports from CDSCO-approved labs
• Product labels, packaging, and Instructions for Use (IFU)
• Quality Management System (QMS) documents (ISO 13485:2016 certification preferred)

Import License Process (MD15)

If you are importing the Pulmonary Function Analysis System into India, an MD15 import license from the Central Licensing Authority is required.

Process overview:

1. Document Preparation: Compile all necessary certificates such as Free Sale Certificate, ISO 13485:2016, CE Certificate, Device & Plant Master Files, and Manufacturing License from the country of origin.
2. Application Submission: File your application online via the CDSCO MD Online Portal using Form MD14.
3. Queries and Clarifications: Respond promptly to any department queries.
4. Grant of License: Once all documents and clarifications are satisfactory, MD15 license is issued.

Import License Documents Required

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

Timeline and Processing Duration

Government Fees and Costs

• MD5 License for Class B devices

  • Application Fee: ₹5,000
  • Per Product Fee: ₹500

• MD15 Import License Fees for Class B devices

  • Site Fee: $2,000 (approx ₹1.6 lakh)
  • Per Product Fee: $1,000 (approx ₹80,000)

Note: Fees are paid online via the CDSCO MD Online Portal.

Common Challenges and Solutions

Challenge 1: Delays in Product Testing

• Solution: Pre-select CDSCO-approved labs with faster turnaround times. Early submission of samples reduces bottlenecks.

Challenge 2: Document Non-Compliance

• Solution: Use comprehensive checklists and templates for Device Master Files and Risk Management Files. Our Device Master File guide can assist.

Challenge 3: Audit Non-Conformities

• Solution: Perform internal mock audits and address potential gaps beforehand to ensure readiness for notified body inspections.

Challenge 4: Query Resolution Delays

• Solution: Maintain clear communication channels with CDSCO officers and respond promptly with accurate information.

Expert Consultation and Support

Navigating the CDSCO regulatory landscape can be complex, especially for specialized devices like Pulmonary Function Analysis Systems. Our expert team offers:

• Customized regulatory strategy tailored to your device and business model
• Documentation drafting and review services
• Coordination for product testing and audits
• Liaison with CDSCO and state authorities

By partnering with us, you leverage 25+ years of expertise, accelerating your license approval and minimizing risks.

Getting Started with Your CDSCO License Application

1. Assess Your Product Classification: Confirm your device as Class B under CDSCO guidelines.
2. Choose License Type: Decide on manufacturing (MD5) or import (MD15) licensing based on your business plan.
3. Gather Required Documents: Begin compiling your Device Master File, Plant Master File, quality certifications, and other mandatory documents.
4. Apply for Test License (if manufacturing): Submit Form MD13 through the CDSCO MD Online Portal to initiate product testing.
5. Plan Testing & Audit: Engage with CDSCO-approved laboratories and notified bodies early in the process.
6. Submit Full License Application: Use Form MD3 for MD5 or Form MD14 for MD15 as applicable.
7. Prepare for Queries: Assign a dedicated team member to manage regulatory communications.

For detailed process insights, please explore our dedicated guides on MD5 License and Import License.

Our extensive experience ensures your Pulmonary Function Analysis System meets all regulatory requirements efficiently, helping you bring this vital respiratory diagnostic device to the Indian healthcare market with confidence.