CDSCO License for External upper esophageal sphincter compression device
Medical Device Information
Intended Use
An external upper esophageal sphincter compression device is intended to apply external pressure on the cricoid cartilage for the purpose of reducing the symptoms of laryngopharyngeal reflux disease.
Comprehensive Guide to CDSCO Licensing for External Upper Esophageal Sphincter Compression Device (Class C)
As specialists with over 25 years of experience in medical device regulatory consultancy, we have assisted more than 500 companies in successfully securing CDSCO licenses. If you manufacture or intend to import an External Upper Esophageal Sphincter Compression Device—classified as Class C under Indian regulations—this guide will provide you with expert insights into the licensing process, timelines, costs, and documentation essentials tailored specifically to your device.
Understanding Your Device and Its Regulatory Importance
An External Upper Esophageal Sphincter Compression Device is designed to apply external pressure on the cricoid cartilage to alleviate symptoms of laryngopharyngeal reflux disease. Being a Class C device under the CDSCO classification means it carries a moderate to high risk, requiring stringent compliance and oversight.
This device falls under the ENT category and was officially notified under Notification No. 29/Misc/03/2020-DC(196) dated 06.08.2021. Proper licensing ensures patient safety, market authorization, and legal compliance in India.
CDSCO Regulatory Framework for Class C Medical Devices
The Central Drugs Standard Control Organization (CDSCO) oversees the regulation of medical devices in India. Class C devices, including your External Upper Esophageal Sphincter Compression Device, require a Manufacturing License (MD9) issued by the Central Licensing Authority.
To comply, manufacturers must adhere to the Medical Device Rules, 2017 and the latest amendments, including obtaining a test license, conducting product testing, and passing audits.
Risk Classification and License Requirements
Your device’s classification as Class C means it carries moderate to high risk. The CDSCO mandates the following licensing procedure:
- Manufacturing License: MD9 License (Form MD7) – issued by Central Licensing Authority
- Test License: MD13 License – prerequisite for product testing
For detailed classification, refer to our Medical Device Classification guide.
Manufacturing License Process (MD9) for Class C Devices
The MD9 license process involves multiple key stages:
- Test License Application (Form MD13): This initial step takes approximately 1.5 to 2 months. It allows you to legally test your device.
- Product Testing: Conducted at CDSCO-approved government laboratories. Testing validates safety and performance. You can find the list of approved testing laboratories here.
- Document Preparation: Prepare comprehensive technical documentation, including Device Master File (DMF) and Plant Master File (PMF).
- License Application (Form MD7): Submit your application for the MD9 license via the CDSCO MD Online Portal.
- Audit: CDSCO inspectors will conduct a thorough audit of your manufacturing facility and quality systems.
- Query Resolution: Address any queries raised by CDSCO or auditors promptly.
- Grant of License: Upon successful compliance, the MD9 license (Form MD9) is issued.
The entire process typically spans 4 to 5 months.
Manufacturing License Documents Required for MD9
To ensure a smooth application, prepare the following documents meticulously:
- Company Constitution/Registration Certificate
- Proof of Ownership or Lease of Manufacturing Premises
- Technical Staff Qualifications and Experience
- Fire Safety No Objection Certificate (NOC)
- Pollution Control Board NOC
- Device Master File (DMF): Details design, materials, and performance. Our Device Master File guide offers detailed instructions.
- Plant Master File (PMF): Documents manufacturing processes and facilities. See our Plant Master File guide for best practices.
- Essential Principles Checklist
- Risk Management File: Following ISO 14971 standards; guidance available in our Risk Management article.
- Test Reports from CDSCO-Approved Labs
- Labels and Instructions for Use (IFU)
- Quality Management System (QMS) Documentation (ISO 13485:2016 certification is highly recommended)
Import License Process (MD15) for Class C Devices
If you intend to import the device rather than manufacture it locally, an Import License (MD15) from the Central Licensing Authority is mandatory.
Key steps include:
- Preparing all relevant documents, including Manufacturing License from the country of origin, Free Sale Certificate, ISO and CE Certificates, DMF, PMF, and Wholesale License.
- Submitting the application on the CDSCO MD Online Portal.
- Responding to any queries raised during the review.
The import license process typically takes 5 to 6 months.
Import License Documents Required
- Valid Manufacturing License from the country of origin
- Free Sale Certificate
- ISO 13485:2016 and CE Certificates
- Device Master File
- Plant Master File
- Wholesale License (if applicable)
- Company Constitution
Timeline and Processing Duration
| License Type | Timeline | Notes |
|---|---|---|
| Test License (MD13) | 1.5 – 2 months | Mandatory before product testing |
| Manufacturing License (MD9) | 4 – 5 months | Includes audit and query resolution |
| Import License (MD15) | 5 – 6 months | No test license required |
Government Fees and Costs
- MD9 Manufacturing License: Application fee of Rs 50,000 + Rs 1,000 per product
- MD13 Test License: Fees vary based on testing labs
- MD15 Import License:
- Class C & D devices: USD 3,000 per site + USD 1,500 per product
It is advisable to budget for additional costs related to testing, documentation, and consultancy services.
Common Challenges and Practical Solutions
Challenge: Delays in test license approval and product testing.
Solution: Submit complete and accurate documentation upfront. Choose CDSCO-approved testing laboratories with proven turnaround times.
Challenge: Non-compliance during audit due to inadequate QMS or incomplete documentation.
Solution: Develop a robust QMS aligned with ISO 13485 and maintain updated Plant and Device Master Files.
Challenge: Multiple rounds of query resolution.
Solution: Engage expert consultants to preemptively address potential regulatory concerns.
Expert Consultation and Support
Navigating the MD9 licensing process for Class C devices can be complex. Our consultancy has a proven track record of guiding companies through every step—from documentation and testing coordination to audit preparation and query management. We leverage our extensive network to connect you with notified bodies and approved labs, ensuring compliance and timely approvals.
Getting Started with Your CDSCO License Application
- Register on the CDSCO MD Online Portal.
- Apply for the Test License (MD13) immediately to initiate product testing.
- Prepare comprehensive documentation, including your Device and Plant Master Files.
- Engage a notified body early for pre-audit readiness; check the list of notified bodies.
- Plan your timeline realistically, anticipating 4-5 months for the complete MD9 licensing process.
- Keep communication channels open with CDSCO and respond promptly to queries.
By following these actionable steps and leveraging expert support, your External Upper Esophageal Sphincter Compression Device can gain timely market authorization, ensuring compliance and patient safety.
For detailed assistance tailored to your device, connect with our regulatory experts and take the first step towards successful CDSCO licensing.
