CDSCO License for Anaesthesia mask stabilizer
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 secure an anaesthesia mask on the face of a patient typically by providing anchorage for the fixation of the mask's headstrap.
Comprehensive Guide to CDSCO Licensing for Anaesthesia Mask Stabilizer (Class A Medical Device)
As a trusted regulatory consultancy with over 25 years of experience and having assisted more than 500 companies in securing CDSCO licenses, we understand the critical importance of compliant market entry for medical devices like the Anaesthesia Mask Stabilizer. This device, classified as Class A under Indian regulations and notified on 12.07.2021 (Notification 29/Misc/03/2020-DC(177)), plays a vital role in anesthesiology by ensuring secure fixation of anesthesia masks on patients. Navigating the CDSCO licensing framework effectively is essential for manufacturers and importers aiming to bring this device to the Indian market.
CDSCO Regulatory Framework for Anaesthesia Mask Stabilizers
The Central Drugs Standard Control Organization (CDSCO) regulates medical devices in India under the Medical Devices Rules, 2017. The Anaesthesia Mask Stabilizer falls under Class A, which is considered low risk. Compliance with CDSCO regulations ensures device safety, quality, and performance standards are met before marketing.
The primary regulatory license required for manufacturing this Class A device in India is the MD5 license, granted by the State Licensing Authority. For imports, an MD15 import license is mandatory, issued by CDSCO's Central Licensing Authority.
Risk Classification and License Requirements for Anaesthesia Mask Stabilizer
- Device Risk Class: Class A (Low Risk)
- License Type for Manufacturing: MD5 License (Application Form MD3)
- License Authority: State Licensing Authority
- Notification Reference: 29/Misc/03/2020-DC(177), dated 12.07.2021
Class A devices like the Anaesthesia Mask Stabilizer require a relatively streamlined process compared to higher-risk devices but still demand thorough documentation and compliance.
Manufacturing License Process (MD5) for Anaesthesia Mask Stabilizer
The MD5 license acquisition process includes several critical stages:
Test License (Form MD13): Initially, obtain a test license which permits procurement of raw materials and commencement of prototype manufacturing. This stage typically takes 1.5 to 2 months.
Product Testing: The device must be tested at CDSCO-approved government testing laboratories to verify compliance with Indian standards. You can find a list of authorized labs on the CDSCO Testing Laboratories page.
Document Preparation: Compile all required documentation including Device Master File (DMF), Plant Master File (PMF), Quality Management System (QMS) documents, and others detailed below.
Application Submission: Apply for the MD5 license via the CDSCO MD Online Portal using Form MD3.
Audit by Notified Body: An audit of manufacturing premises and processes is conducted by a notified body. Refer to the list of notified bodies to select an authorized auditor.
Resolution of Queries: Address any queries raised by the licensing authority or auditor promptly.
Grant of MD5 License: Upon satisfactory completion of all steps, the MD5 manufacturing license will be issued on Form MD5.
The entire process generally spans 3 to 4 months from test license application to license grant.
Manufacturing License Documents Required for Anaesthesia Mask Stabilizer
To ensure a smooth application, prepare the following documents meticulously:
- Certified copy of Certificate of Incorporation or company constitution
- Proof of ownership or valid lease agreement of manufacturing premises
- Details and qualifications of Technical Staff involved in manufacturing
- Fire Safety No Objection Certificate (NOC) and Pollution Control Board NOC
- Device Master File (DMF): Comprehensive documentation on device design, specifications, and manufacturing process. Our detailed Device Master File guide can assist you.
- Plant Master File (PMF): Information about the manufacturing facility, equipment, and quality control processes. Refer to our Plant Master File guide.
- Essential Principles Checklist: Demonstrates compliance with Indian medical device regulations
- Risk Management File: Analysis and mitigation plans for identified risks in the device. See practical tips in our Risk Management resource.
- Product Test Reports from CDSCO-approved labs
- Sample Labels and Instructions for Use (IFU)
- Quality Management System (QMS) Documents: Typically ISO 13485:2016 certification and associated procedures
Attention to detail in document preparation significantly reduces processing delays.
Import License Process (MD15) for Anaesthesia Mask Stabilizer
For importers, obtaining an MD15 license through the CDSCO Central Licensing Authority is mandatory before marketing the device in India. The steps include:
Document Preparation: Collect all required import license documents including the manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016 certification, CE Certificate, DMF, PMF, wholesale license, and company constitution.
Application Submission: File Form MD14 on the CDSCO MD Online Portal.
Queries and Clarifications: Respond to any department queries swiftly.
License Grant: License granted on Form MD15, usually within 5 to 6 months.
Note that unlike manufacturing licenses, test licenses are not required for imports.
Import License Documents Required
- Valid Manufacturing License from the country of origin
- Free Sale Certificate
- ISO 13485:2016 Certificate
- CE Mark Certificate
- Device Master File
- Plant Master File
- Valid Wholesale License
- Company Constitution or Incorporation Certificate
Timeline and Processing Duration
| License Type | Process Steps | Approximate Duration |
|---|---|---|
| MD5 Manufacturing | Test License + Testing + Audit + Queries + Grant | 3 - 4 months |
| MD15 Import | Document preparation + Queries + Grant | 5 - 6 months |
Being proactive in document preparation and addressing queries promptly can significantly improve these timelines.
Government Fees and Costs
- MD5 License: Rs. 5,000 per application + Rs. 500 per product
- Test License (MD13): Included in the above process
Costs cover application fees, testing, and audit expenses.
Common Challenges and Solutions
Delayed Testing and Audit: Scheduling audits and lab testing can cause delays. Early booking with notified bodies and testing labs helps mitigate this.
Incomplete Documentation: Missing or inconsistent documents are a frequent cause of application rejection. Utilize checklists and expert reviews.
Responding to Queries: Delayed or inadequate responses to authority queries prolong licensing. Assign dedicated regulatory personnel for swift communication.
Technical Staff Qualifications: Ensure technical staff meet CDSCO criteria with proper documentation.
Our team has successfully navigated these challenges for numerous clients by providing tailored guidance.
Expert Consultation and Support
With over 25 years of domain expertise, we offer end-to-end support including:
- Pre-assessment of your readiness
- Documentation drafting and review
- Coordination with notified bodies and testing labs
- Application filing and follow-up
- Training on post-market compliance
We ensure your Anaesthesia Mask Stabilizer complies fully and reaches the Indian market without unnecessary delays.
Getting Started with Your CDSCO License Application
Assess Your Device Classification: Confirm your device is Class A under CDSCO rules. For detailed classification, visit our Medical Device Classification resource.
Initiate Test License Application: Apply for the test license using Form MD13 on the CDSCO MD Online Portal.
Engage a Notified Body and Testing Lab: Identify and liaise with authorized auditors and testing labs early.
Compile Required Documentation: Utilize our Device Master File and Plant Master File guides.
Submit Application for MD5 License: After successful testing and audit, submit Form MD3 online.
Prepare for Audit: Ensure your manufacturing site and QMS are in compliance for the notified body audit.
Respond to Queries Promptly: Maintain clear communication with CDSCO authorities.
Starting early and partnering with experienced consultants can expedite your market entry for the Anaesthesia Mask Stabilizer.
For personalized assistance and detailed procedural support, reach out to our regulatory experts who have guided 500+ companies to successful CDSCO licensing outcomes.
