CDSCO License for Nose clip
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 device intended to be used to compress the nose externally, to ensure that airflow is exclusively conducted through the mouth during examinations of the pulmonary function and/or to stop nosebleeds.
Comprehensive Guide to CDSCO Licensing for Nose Clip (Class A Medical Device)
As seasoned regulatory consultants with over 25 years of experience and having successfully guided more than 500 companies through India's medical device licensing landscape, we understand the intricacies of obtaining CDSCO licenses for devices like the Nose Clip. This device, classified as a Class A medical device under anesthesiology, plays a critical role in pulmonary function examinations and controlling nosebleeds by externally compressing the nose.
Navigating the regulatory framework effectively ensures timely market entry and compliance with Indian laws. Below, we provide a detailed, actionable roadmap tailored specifically for manufacturers and importers of the Nose Clip.
CDSCO Regulatory Framework for Nose Clip (Class A Medical Device)
The Central Drugs Standard Control Organization (CDSCO) governs the import, manufacturing, and sale of medical devices in India. According to the Medical Device Rules (MDR) 2017 and subsequent notifications, the Nose Clip falls under Class A, indicating low risk. This classification mandates obtaining the MD5 manufacturing license for Indian manufacturers, issued by the respective State Licensing Authority.
The recent notification [29/Misc/03/2020-DC(177)] dated 12.07.2021 officially includes the Nose Clip under the CDSCO regulatory ambit, ensuring compliance with quality, safety, and efficacy standards.
Risk Classification and License Requirements for Nose Clip
- Device Name: Nose Clip
- Risk Class: A (Low Risk)
- Category: Anesthesiology
- License Type: MD5 (Manufacturing License for Class A devices)
- Governing Authority: State Licensing Authority
For Class A devices like the Nose Clip, the licensing process is streamlined but still requires adherence to specific documentation, testing, and audit procedures.
Manufacturing License Process (MD5) for Nose Clip
The MD5 license process involves several key steps:
Test License Application (Form MD13): Before the manufacturing license, apply for a test license on the CDSCO MD Online Portal to legally produce samples for testing.
Product Testing: Submit samples to government-approved testing laboratories. You can check the list of authorized labs here.
Document Preparation & Submission: Compile all required documents and submit the MD5 application (Form MD3) via the CDSCO portal.
Audit by Notified Body: An audit is conducted by a notified body to verify compliance. Refer to the list of notified bodies.
Query Resolution: Address any queries or deficiencies raised by CDSCO or the notified body promptly.
License Grant: Upon satisfactory compliance, the State Licensing Authority issues the MD5 license (Form MD5).
For a detailed step-by-step guide, our MD5 License Guide offers practical insights.
Manufacturing License Documents Required for Nose Clip
The following documents are mandatory for MD5 license submission:
- Company Constitution (e.g., Partnership Deed, Memorandum & Articles of Association)
- Proof of Ownership or Lease Agreement of Manufacturing Premises
- Details of Technical Staff (Qualification certificates and experience)
- Fire No Objection Certificate (NOC)
- Pollution Control Board NOC
- Device Master File (DMF): Detailed device specifications, materials, manufacturing process (Device Master File Guide)
- Plant Master File (PMF): Description of manufacturing facility and equipment (Plant Master File Guide)
- Essential Principles Checklist affirming compliance with MDR
- Risk Management File demonstrating hazard analysis and mitigation (Risk Management)
- Product Test Reports from approved labs
- Labeling and Instructions for Use (IFU)
- Quality Management System (QMS) Documents, preferably ISO 13485:2016 certification
Import License Process (MD15) for Nose Clip
Though the Nose Clip is a Class A device, importers must obtain the MD15 import license granted by the Central Licensing Authority.
Key steps include:
- Document preparation (including manufacturing license from the country of origin, Free Sale Certificate, CE Certificate, ISO 13485:2016)
- Application submission on CDSCO MD Online Portal
- Addressing departmental queries
- License grant within estimated timelines
For specifics, our Import License Guide provides expert advice.
Import License Documents Required for Nose Clip
- Valid Manufacturing License from the country of origin
- Free Sale Certificate
- ISO 13485:2016 certification
- CE Certificate or equivalent
- Device Master File and Plant Master File
- Wholesale License
- Company Constitution Documents
Timeline and Processing Duration
| Process Stage | Duration |
|---|---|
| Test License (Form MD13) | 1.5 – 2 months |
| Product Testing | 3 – 4 weeks |
| Document Preparation | 2 – 3 weeks |
| MD5 Application Processing | 3 – 4 months total |
Overall, expect approximately 3 to 4 months from test license application to final MD5 license grant.
Government Fees and Costs
- MD5 License Application Fee: Rs. 5,000 per application
- Product Fee: Rs. 500 per product (Nose Clip)
- Test License Fee: Included in initial application
Budgeting for notified body audit and testing fees is essential; these vary based on the notified body and testing scope.
Common Challenges and Solutions
- Delayed Test Reports: Choose well-established government-approved labs with proven turnaround times.
- Incomplete Documentation: Utilize detailed checklists and consult with experienced regulatory professionals to avoid rejections.
- Audit Non-Compliance: Prepare your manufacturing site and QMS meticulously, referencing notified body audit criteria.
- Query Resolution Delays: Assign dedicated personnel to respond swiftly to CDSCO queries.
Expert Consultation and Support
With our extensive track record assisting over 500 companies, we provide end-to-end support including:
- Preparing Device and Plant Master Files
- Coordinating testing with approved labs
- Liaising with notified bodies
- Handling queries and audit preparations
Engage expert consultants early to streamline your regulatory journey and minimize costly delays.
Getting Started with Your CDSCO License Application for Nose Clip
- Register on the CDSCO MD Online Portal.
- Apply for a Test License (Form MD13) to start manufacturing samples legally.
- Plan product testing with approved labs.
- Compile comprehensive documentation including DMF, PMF, risk management, and QMS files.
- Submit your MD5 application (Form MD3) through the portal.
- Prepare for the notified body audit by reviewing compliance requirements.
- Respond promptly to any queries from CDSCO or auditors.
Starting early and following these precise steps can reduce your time-to-market and ensure compliance with regulatory expectations for the Nose Clip in India.
For detailed assistance tailored to your product and business needs, contact us to leverage our 25+ years of regulatory expertise.
