CDSCO License for Probiotic oropharyngeal mucosa dressing
Medical Device Information
Intended Use
A non-sterile substance intended to be applied to the mucosa of the mouth and/or pharynx to facilitate saprophytic microflora colonization within the oral cavity/pharynx, typically following antibiotic therapy, bacterial infection, or injury. It includes probiotic bacteria (e.g., Streptococcus salivarius, Streptococcus oralis) and compounds that create a barrier to facilitate growth of the probiotic bacteria.
Introduction to Probiotic Oropharyngeal Mucosa Dressing and Its Regulatory Importance
Probiotic oropharyngeal mucosa dressings represent an innovative advancement in gastroenterology medical devices. Designed as a non-sterile therapeutic barrier applied to the mucosa of the mouth and pharynx, these dressings facilitate saprophytic microflora colonization, aiding patients recovering from antibiotic therapy, bacterial infections, or mucosal injury. Given their biological components, such as Streptococcus salivarius and Streptococcus oralis, along with barrier compounds, these devices fall under Class C risk category as per CDSCO regulations, requiring stringent regulatory compliance before entering the Indian market.
Navigating the Central Drugs Standard Control Organization (CDSCO) licensing landscape is critical for manufacturers and importers to ensure timely market access while adhering to safety and efficacy standards. With over 25 years of experience and having supported more than 500 companies, we provide you with detailed insights and practical guidance for successful licensing of probiotic oropharyngeal mucosa dressings.
CDSCO Regulatory Framework for Probiotic Oropharyngeal Mucosa Dressings
The CDSCO regulates medical devices based on risk classification, intended use, and composition. For devices like probiotic oropharyngeal dressings, the regulatory framework mandates compliance with the Medical Device Rules, 2017, and adherence to the notified guidelines under Notification 29/Misc./03/2020-DC (182) dated 27.09.2021.
This device falls under the gastroenterology category and requires central licensing authority approval due to its Class C classification, indicating moderate to high risk.
Risk Classification and License Requirements for Class C Devices
According to the CDSCO classification, your probiotic oropharyngeal mucosa dressing is a Class C device due to its intended biological interaction and patient contact. This classification triggers the following regulatory requirements:
- Manufacturing License: MD9 license (Application Form MD7), issued by the CDSCO Central Licensing Authority.
- Import License: MD15 license (Application Form MD14), also granted by the Central Licensing Authority.
Understanding the difference between these licenses is crucial. The MD9 license is mandatory for domestic manufacturers, while the MD15 license applies to importers.
For detailed classification insights, manufacturers can refer to our Medical Device Classification resource.
Manufacturing License Process (MD9) for Class C Devices
Obtaining an MD9 license involves a multi-step process designed to ensure product safety and compliance:
Test License Application (Form MD13): Begin by applying for a test license, which typically takes 1.5 to 2 months. This step allows you to conduct necessary product testing.
Product Testing: Get your probiotic dressing tested at CDSCO-approved laboratories. Testing covers microbiological safety, stability, and functional efficacy. Refer to the list of Testing Laboratories for approved facilities.
Document Preparation: Compile comprehensive documentation, including Device Master File and Plant Master File, quality management system (QMS) documents, risk management files, and more.
Submission of Application (Form MD7): File the manufacturing license application through the CDSCO MD Online Portal, attaching all required documents.
CDSCO Inspection: After submission, CDSCO inspectors conduct an audit of your manufacturing premises and QMS.
Query Resolution: Address any queries raised by CDSCO or the audit team promptly.
Grant of MD9 License: Upon satisfactory review and inspection, CDSCO issues the MD9 manufacturing license.
For a comprehensive walkthrough, our MD9 License Guide offers valuable insights.
Manufacturing License Documents Required for MD9
The following documents are essential for the MD9 application:
- Company Constitution and Incorporation Certificate
- Proof of Ownership or Lease of Manufacturing Premises
- Qualification and Experience Documents of Technical Staff
- Fire NOC and Pollution Control Board NOC
- Device Master File detailing the probiotic dressing's formulation, materials, and manufacturing process (Device Master File Guide)
- Plant Master File outlining manufacturing facilities and equipment (Plant Master File Guide)
- Essential Principles Checklist demonstrating compliance with safety and performance standards
- Risk Management File documenting risk assessment and mitigation strategies (Risk Management)
- Product Test Reports from CDSCO-approved labs
- Labels and Instructions for Use (IFU) compliant with CDSCO requirements
- Quality Management System (QMS) Documents, preferably ISO 13485:2016 certification
Ensuring accuracy and completeness in these documents reduces delays during review.
Import License Process (MD15) for Class C Devices
For importers wishing to bring probiotic oropharyngeal mucosa dressings into India, the MD15 license is mandatory. The process includes:
Document Preparation: Compile documentation such as manufacturing license, free sale certificate from the country of origin, ISO 13485:2016 certification, CE certificates (if applicable), Device and Plant Master Files, wholesale license, and company constitution.
Application Submission: Submit Form MD14 for the MD15 license via the CDSCO MD Online Portal.
Departmental Review and Queries: CDSCO evaluates the application and raises any queries.
Grant of License: Upon satisfactory compliance, CDSCO issues the MD15 import license.
The entire process typically takes 5 to 6 months. For detailed guidance, consult our Import License Guide.
Import License Documents Required
Key documents for MD15 import license include:
- Manufacturing License from the country of origin
- Free Sale Certificate
- ISO 13485:2016 Certification
- CE Certificate or equivalent international approvals
- Device Master File and Plant Master File
- Wholesale License for distribution in India
- Company Constitution and Incorporation Documents
Providing complete and verifiable documents expedites license approval.
Timeline and Processing Duration
| License Type | Approximate Duration |
|---|---|
| Test License (MD13) | 1.5 to 2 months |
| MD9 Manufacturing | 4 to 5 months (including test license) |
| MD15 Import License | 5 to 6 months |
The timelines account for document verification, laboratory testing, audits, and query resolution. Proactive communication with CDSCO and thorough preparation shorten approval times.
Government Fees and Costs
| License Type | Application Fee | Per Product Fee |
|---|---|---|
| MD9 (Class C/D) | Rs. 50,000 | Rs. 1,000 |
| MD15 (Class C/D) | USD 3,000 per site | USD 1,500 per product |
Additional costs include testing fees at approved labs and expenses related to documentation and consultancy services.
Common Challenges and Solutions
Challenge: Delays due to incomplete documentation.
- Solution: Utilize detailed checklists and professional consultation to prepare all documents accurately.
Challenge: Difficulty in scheduling audits and inspections.
- Solution: Maintain open communication with CDSCO and prepare premises and teams ahead of inspections.
Challenge: Complexity in compiling Device and Plant Master Files.
- Solution: Refer to our expert guides on Device Master Files and Plant Master Files for structured documentation.
Challenge: Prolonged query resolution.
- Solution: Assign dedicated regulatory personnel to respond promptly and comprehensively.
Expert Consultation and Support
With over 25 years of regulatory expertise, we have successfully guided 500+ companies through the CDSCO licensing maze. Our services include:
- Comprehensive gap analysis and documentation support
- Coordination with notified bodies and CDSCO inspectors
- Assistance in scheduling product testing and audit
- End-to-end application submission and query management
Partnering with experienced consultants accelerates approval and ensures compliance.
Getting Started with Your CDSCO License Application
Assess your Device Classification: Confirm your probiotic oropharyngeal mucosa dressing as Class C using tools like the Medical Device Classification resource.
Initiate Test License Application: Apply for Form MD13 via the CDSCO MD Online Portal to begin testing.
Engage Approved Testing Laboratories: Schedule product testing early by reviewing the list of Testing Laboratories.
Prepare Master Files and QMS Documents: Utilize our guides to develop robust Device and Plant Master Files.
Plan for Audit and Inspection: Identify notified bodies and inspection timelines; consult the Notified Bodies List.
Submit Manufacturing (MD9) or Import (MD15) License Application: Complete application forms and submit through the CDSCO portal.
Respond to Queries Promptly: Establish a dedicated team for regulatory communication.
By following these actionable steps and leveraging expert support, manufacturers and importers can confidently navigate the CDSCO licensing process for probiotic oropharyngeal mucosa dressings and successfully enter the Indian market.
