CDSCO License for Nasal aspirator, electric
Medical Device Information
Important Notice for Class A Devices
Class A Non-sterile Non Measuring devices are exempt from MD5 and MD15 licenses. Only CDSCO registration is required as per GSR 777(E).
Intended Use
A portable, hand-held, battery-powered suction device designed to enable an adult to gently suction and clear excessive mucus from the nasal passages of an infant or child to facilitate easier breathing. It consists of a handgrip that contains the batteries, a small electric pump that creates the suction, and typically has a silicone nozzle attached to a detachable, washable, collection cup at the distal end. It is designed for domestic use and is typically applied superficially the nasal opening (i.e., not inserted into the nasal cavity). This is a reusable device.
Comprehensive CDSCO Licensing Guide for Electric Nasal Aspirators (Class A Medical Device)
As a seasoned regulatory consultancy with over 25 years of experience and more than 500 successful client approvals, we understand the intricacies involved in obtaining a CDSCO license for medical devices like the electric nasal aspirator. This portable, battery-powered suction device designed for pediatric use falls under Class A—the lowest risk category—yet it demands strict compliance with CDSCO regulatory requirements to ensure safety, efficacy, and market entry in India.
Understanding the CDSCO Regulatory Framework for Electric Nasal Aspirators
The Central Drugs Standard Control Organization (CDSCO) mandates that all medical devices marketed in India must comply with its regulatory framework. For Class A devices such as the nasal aspirator, the licensing responsibility lies with the State Licensing Authority under the MD5 license scheme. This framework ensures that manufacturers meet quality standards, risk management protocols, and performance criteria before placing the device in the market.
Risk Classification and License Requirements for Nasal Aspirators
Our electric nasal aspirator is classified as a Class A medical device based on its intended use and risk profile. Class A devices are considered low risk and thus require:
- MD5 Manufacturing License (Application Form MD3) granted by the State Licensing Authority
- Compliance with essential principles and risk management requirements
- Product testing via government-approved laboratories
Class A devices benefit from a streamlined approval process relative to higher-risk categories but still involve critical steps including a test license, product testing, and notified body audit.
Detailed Manufacturing License Process (MD5) for Electric Nasal Aspirators
The MD5 license process typically spans 3 to 4 months and involves the following phases:
Application for Test License (Form MD13) – This initial license allows the manufacturer to produce samples for testing. It generally takes 1.5 to 2 months to obtain.
Product Testing at CDSCO-Approved Laboratories – Samples of the nasal aspirator must be tested for safety, performance, and compliance. Refer to the list of testing laboratories approved by CDSCO.
Documentation Preparation – Compile essential documents including Device Master File, Plant Master File, Risk Management File, and Quality Management System (QMS) records.
Submission of Manufacturing License Application (Form MD3) – Submit via the CDSCO MD Online Portal.
Audit by Notified Body – The notified body conducts an audit of manufacturing facilities and QMS compliance. You can check the list of notified bodies authorized for Class A devices.
Resolution of Queries – Respond promptly to any queries raised by the department or notified body to avoid delays.
Grant of Manufacturing License (Form MD5) – Upon satisfactory evaluation, the license is issued, enabling commercial manufacturing.
Comprehensive Manufacturing License Documents Required
To avoid common pitfalls, ensure you prepare the following high-quality documents:
- Company Constitution/Registration Certificate
- Proof of Ownership or Lease Agreement for Manufacturing Premises
- Technical Staff Qualification and Experience Details
- Fire NOC and Pollution Control NOC
- Device Master File (DMF) detailing design, components, and performance
- Plant Master File (PMF) describing manufacturing infrastructure and processes
- Essential Principles Checklist confirming compliance with CDSCO guidelines
- Risk Management File documenting identified hazards and mitigation (see our risk management guide)
- Test Reports from Approved Laboratories
- Labels, Packaging, and Instructions for Use (IFU)
- Quality Management System (QMS) Documents such as SOPs and training records
Our comprehensive Device Master File guide and Plant Master File guide offer detailed templates and best practices.
Import License Process (MD15) for Electric Nasal Aspirators
If you plan to import electric nasal aspirators into India, the CDSCO requires an MD15 import license issued by the Central Licensing Authority. This process takes approximately 5 to 6 months and involves:
- Preparation of documents including a valid manufacturing license, Free Sale Certificate from the country of origin, ISO 13485:2016 certification, CE Certificate, Device and Plant Master Files, and Wholesale License
- Submission of the application on Form MD14 via the CDSCO MD Online Portal
- Resolution of departmental queries before license grant on Form MD15
Government fees vary by risk class; for Class A devices, fees are approximately 50 per product.
Timeline and Processing Duration Summary
| Process Step | Duration |
|---|---|
| Test License Application (MD13) | 1.5 – 2 months |
| Product Testing | 3 – 4 weeks |
| Document Preparation | 3 – 4 weeks |
| Manufacturing License (MD5) | 1 – 1.5 months |
| Total Estimated Time | 3 – 4 months |
Government Fees and Cost Breakdown
- MD5 Manufacturing License: Rs 5,000 per application + Rs 500 per product
- Test License (MD13): Included in the above process
- Notified Body Audit Fees: Varies, generally Rs 50,000 – Rs 70,000
- Product Testing Fees: Depends on lab, typically Rs 20,000 – Rs 40,000 per product
Budgeting accurately for these costs upfront helps prevent unexpected delays.
Common Challenges and Practical Solutions
- Incomplete Documentation: Many applicants submit insufficient technical files. To avoid this, use our document checklist and templates.
- Delayed Test Reports: Coordinate early with CDSCO-approved labs to schedule testing and ensure timely submission.
- Audit Non-compliance: Prepare your manufacturing site thoroughly, including QMS adherence and staff training.
- Query Resolution Delays: Assign a dedicated regulatory liaison to address CDSCO queries promptly.
Expert Consultation and Support
Navigating the CDSCO licensing pathway for devices like the electric nasal aspirator demands precision and expertise. Our consultancy has supported over 500 manufacturers and importers, providing:
- Tailored regulatory strategy and risk classification advice
- Document preparation and gap analysis
- Coordination with notified bodies and testing laboratories
- End-to-end application submission and follow-up
Reach out early in your product development cycle for a smoother pathway to market.
Getting Started with Your CDSCO License Application for Electric Nasal Aspirators
Assess your device classification and confirm it's Class A via official CDSCO guidance or our medical device classification resource.
Apply for the Test License (Form MD13) through the CDSCO MD Online Portal.
Arrange product testing at a CDSCO-approved laboratory. Book early to avoid bottlenecks.
Prepare the complete documentation package, leveraging our DMF and PMF guides.
Submit your MD5 Manufacturing License application (Form MD3) online.
Coordinate the notified body audit and promptly address any observations.
Upon license grant, initiate production and market your device legally in India.
By following these actionable steps and leveraging expert support, manufacturers and importers can confidently enter the Indian pediatric medical device market with their electric nasal aspirators, ensuring compliance and patient safety from day one.
