CDSCO License for Dry powder inhaler

Comprehensive Guide to CDSCO Licensing for Dry Powder Inhalers (Class A Medical Devices)

Dry powder inhalers (DPIs) are essential respiratory devices designed to deliver powdered medication directly into the bronchial airways via oral administration. Given their critical role in managing respiratory conditions like asthma and COPD, regulatory compliance in India is crucial for manufacturers and importers aiming to bring DPIs to market. With over 25 years of experience and having supported 500+ companies, we provide you with an actionable roadmap for obtaining the CDSCO license for your Dry Powder Inhaler.

CDSCO Regulatory Framework for Dry Powder Inhalers

The Central Drugs Standard Control Organization (CDSCO) governs medical devices in India under the Medical Device Rules (MDR), 2017. Dry powder inhalers fall under the respiratory category and are classified as Class A devices — considered low risk. This classification means the licensing authority is the State Licensing Authority, and the process involves an MD5 manufacturing license.

Your device is notified under File No. 29/Misc/03/2020-DC(197), dated 6.8.2021, which officially recognizes the DPI as a regulated medical device requiring mandatory registration and licensing.

Risk Classification and License Requirements for DPIs

Risk Class: A (Low risk)
License Type: MD5 Manufacturing License (Form MD3)
Licensing Authority: State Licensing Authority
Total Timeline: Approximately 3-4 months
Fees: Rs 5,000 per application + Rs 500 per product

Class A devices require a test license (Form MD13) initially, followed by product testing, audit by a notified body, and final grant of the MD5 license.

Manufacturing License Process (MD5) for Dry Powder Inhalers

Apply for Test License (Form MD13): This initial step allows you to manufacture the DPI for testing purposes. Expect 1.5 to 2 months for approval.
Product Testing: Get your DPI tested at government-approved laboratories. This testing verifies compliance with Indian standards and essential principles.
Prepare Documentation: Compile all required documents including Device Master File, Plant Master File, Quality Management System records, risk management files, and more.
Apply for MD5 License (Form MD3): Submit your application via the CDSCO MD Online Portal.
Audit by Notified Body: The State Licensing Authority will schedule an audit through a notified body. Refer to the list of notified bodies to understand audit scope and prepare accordingly.
Query Resolution: Address any observations or queries raised by the regulatory authority or notified body promptly.
Grant of License: Upon satisfactory audit and document review, the MD5 license will be issued.

Manufacturing License Documents Required for DPIs

Company Constitution and Registration Proof
Proof of Premises Ownership or Lease Agreement
Qualification and Experience Documents of Technical Staff
Fire NOC and Pollution Control Board NOC
Device Master File: Detailed technical specifications and design of the DPI. Our Device Master File guide can help streamline this.
Plant Master File: Manufacturing facility details. Learn how to prepare it efficiently with our Plant Master File guide.
Essential Principles Checklist confirming compliance with MDR
Risk Management File demonstrating hazard analysis and mitigation measures
Test Reports from government-approved labs
Product Labels, Instructions for Use (IFU)
Quality Management System documentation (ISO 13485 compliant recommended)

Import License Process (MD15) for Dry Powder Inhalers

If you plan to import DPIs instead of manufacturing locally, you will require an MD15 import license granted by the Central Licensing Authority. The process generally takes 5-6 months and requires comprehensive documentation, including free sale certificates, ISO 13485 certification, CE certificates, and existing manufacturing licenses.

You can find a detailed walkthrough in our Import License Guide.

Import License Documents Required

Valid Manufacturing License from the country of origin
Free Sale Certificate
ISO 13485:2016 Quality Management System Certificate
CE Certificate or equivalent
Device Master File & Plant Master File
Wholesale License in India
Company Constitution and Importer Registration

Timeline and Processing Duration

Test License Approval (Form MD13): 1.5 to 2 months
Product Testing: 1 month (varies by lab capacity; see approved Testing Laboratories)
Audit & Queries Resolution: 1 to 1.5 months
Final License Grant: After successful audit and compliance

Total estimated time: 3 to 4 months for manufacturing license (MD5) for Dry Powder Inhalers.

Government Fees and Costs

Application Fee for MD5 License: Rs 5,000
Product Fee: Rs 500 per product variant
Additional costs include testing fees at government labs and audit fees charged by notified bodies (varies).

Budgeting for these costs upfront helps avoid surprises. We recommend consulting with notified bodies early to understand their fee structures.

Common Challenges and Solutions

Challenge: Incomplete or poorly organized documentation causing audit delays.

Solution: Use our detailed checklists and templates for Device and Plant Master Files. Early preparation of risk management files aligned with ISO 14971 principles is critical.

Challenge: Delays in product testing due to lab backlogs.

Solution: Schedule testing well in advance and consider alternate government-approved labs from the Testing Laboratories list.

Challenge: Queries from CDSCO or notified bodies requiring detailed responses.

Solution: Maintain clear records and engage experienced consultants who understand regulatory nuances. Timely and precise response to queries significantly reduces processing time.

Expert Consultation and Support

Navigating the CDSCO licensing process for Dry Powder Inhalers can be complex, especially for first-time applicants. With our 25+ years of expertise and a track record of helping 500+ companies, we offer tailored support:

End-to-end documentation preparation
Coordination with notified bodies and testing labs
Audit readiness and mock inspections
Regulatory strategy and risk management implementation

Engaging expert consultants early can reduce your approval timeline by up to 30% and ensure compliance with evolving regulatory standards.

Getting Started with Your CDSCO License Application

Assess your device classification and confirm your licensing pathway as Class A (MD5).
Register on the CDSCO MD Online Portal to initiate your test license application (Form MD13).
Compile essential documentation focusing on your Device Master File and Plant Master File.
Engage a notified body from the official list of notified bodies early to schedule audits.
Coordinate with government-approved testing laboratories to arrange product testing well in advance.
Prepare your Quality Management System and Risk Management documentation to demonstrate compliance.

By following these steps and leveraging expert support, your Dry Powder Inhaler can successfully obtain the CDSCO MD5 license and enter the Indian market with confidence. For personalized assistance or to initiate your application process, contact us today.

References:

CDSCO License for Dry powder inhaler

Medical Device Information

Important Notice for Class A Devices

Intended Use