CDSCO License for Professional Examination Gown
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 garment made of natural and/or synthetic materials intended to be worn by healthcare providers, sometimes over scrub suits, while examining patients. It can be fluid resistant or impervious to fluid. An examination gown is used during patient examination procedures to protect both the patient and staff from the transfer of contaminants such as microorganisms or body fluids.
Introduction to Professional Examination Gown and Regulatory Importance
Professional Examination Gowns serve as a critical component of Personal Protective Equipment (PPE) in healthcare settings. Designed to protect both patients and healthcare providers from contamination during examinations, these gowns must meet stringent quality and safety standards. Given their role in infection control, regulatory compliance with India's Central Drugs Standard Control Organization (CDSCO) is mandatory before manufacturing or importing these gowns. Navigating the CDSCO licensing process efficiently ensures timely market entry and builds trust with healthcare customers.
CDSCO Regulatory Framework for Professional Examination Gowns
As a Class A medical device under the PPE category, Professional Examination Gowns fall under the lowest risk classification according to CDSCO’s medical device classification system. This classification streamlines the licensing route but still requires adherence to essential regulatory and quality norms. Compliance includes obtaining an MD5 Manufacturing License from the State Licensing Authority before production. For imports, the MD15 Import License from the Central Licensing Authority is mandatory.
Understanding the applicable regulations helps manufacturers and importers avoid delays and penalties while ensuring device safety for end-users.
Risk Classification and License Requirements for Class A Devices
Professional Examination Gowns are classified as Class A devices due to their low risk profile. This classification impacts the type of license required and the approval process:
- Manufacturing License: MD5 License (Application Form MD3) issued by the State Licensing Authority
- Import License: MD15 License (Application Form MD14) issued by the Central Licensing Authority
The MD5 license process involves a preliminary test license (MD13), product testing, audit by a notified body, and finally, license grant. This rigorous process ensures conformity to quality and safety standards.
For detailed classification guidance, visit our Medical Device Classification resource.
Manufacturing License Process (MD5) for Professional Examination Gowns
Obtaining an MD5 license for manufacturing Professional Examination Gowns is a multi-step procedure:
- Test License Application (Form MD13): Submit an application to the State Licensing Authority to obtain a test license. This allows manufacturing of limited batches for testing purposes.
- Product Testing: Samples must be tested at CDSCO-approved laboratories to confirm compliance with applicable standards. Refer to the Testing Laboratories list for approved centers.
- Document Preparation: Compile all necessary documents including Device Master File, Plant Master File, Essential Principles Checklist, and Risk Management File.
- Manufacturing License Application (Form MD3): Submit the complete application through the CDSCO MD Online Portal.
- Notified Body Audit: An audit by a notified body listed here is conducted to verify compliance with QMS and manufacturing practices.
- Queries and Clarifications: Address any queries raised by the licensing authority or notified body promptly.
- License Grant: Upon successful completion of all steps, the MD5 manufacturing license is issued.
This entire process typically takes 3 to 4 months from test license application to final license grant.
For comprehensive guidance, see our detailed MD5 License Guide.
Manufacturing License Documents Required for Professional Examination Gown
The MD5 license application requires meticulous documentation, including:
- Company Constitution and Registration Proof
- Proof of Ownership or Lease of Manufacturing Premises
- Details and Qualification Certificates of Technical Staff
- Fire NOC and Pollution Control NOC
- Device Master File (DMF): Specifications, design, and compliance documents (Device Master File Guide)
- Plant Master File (PMF): Manufacturing process, quality control, and facilities details (Plant Master File Guide)
- Essential Principles Compliance Checklist
- Risk Management File demonstrating hazard analysis and mitigation (Risk Management)
- Product Test Reports from approved labs
- Labels, Instructions for Use (IFU)
- Quality Management System (QMS) Documents (ISO 13485:2016 preferred)
Ensuring completeness and accuracy of these documents reduces back-and-forth during review.
Import License Process (MD15) for Professional Examination Gowns
For companies intending to import Professional Examination Gowns into India, the MD15 Import License is mandatory. The process is as follows:
- Document Preparation: Assemble all required import documents including manufacturing license from country of origin, Free Sale Certificate, ISO 13485:2016 certification, CE Certificate, Device Master File, Plant Master File, and Wholesale License.
- Application Submission: Submit the application on the CDSCO MD Online Portal.
- Review and Queries: Respond to any queries or additional information requests from CDSCO.
- License Issuance: Upon satisfactory review, the MD15 Import License is granted.
No test license is required for import applications. The total processing time is approximately 5 to 6 months.
Our Import License Guide provides step-by-step assistance.
Import License Documents Required
Key documents necessary for MD15 license include:
- Valid Manufacturing License from Country of Origin
- Free Sale Certificate confirming market authorization abroad
- ISO 13485:2016 Certification
- CE Marking Certificate (if applicable)
- Device Master File
- Plant Master File
- Wholesale License for distribution in India
- Company Constitution and Registration Details
Thoroughly preparing these documents upfront accelerates approval.
Timeline and Processing Duration
| License Type | Processing Time | Key Milestones |
|---|---|---|
| MD5 Manufacturing | 3 to 4 months | Test License (1.5-2 months), Testing, Audit, Final License |
| MD15 Import | 5 to 6 months | Document Preparation, Review, Queries, License Grant |
Being proactive in document preparation and prompt response to queries can reduce delays significantly.
Government Fees and Costs
For Professional Examination Gowns categorized as Class A:
- MD5 Manufacturing License:
- Application Fee: Rs. 5,000 per application
- Product Fee: Rs. 500 per product
- MD15 Import License:
- Site Fee: Approximately $1,000 per site
- Product Fee: Approximately $50 per product
These fees are payable online via the CDSCO MD Online Portal during application submission.
Common Challenges and Practical Solutions
Challenge 1: Delays due to incomplete documentation
- Solution: Use detailed checklists such as the Device Master File Guide and Plant Master File Guide to ensure completeness.
Challenge 2: Difficulty in coordinating product testing
- Solution: Choose from CDSCO-approved Testing Laboratories and schedule tests early in the process to avoid bottlenecks.
Challenge 3: Audit non-compliance findings
- Solution: Engage notified bodies listed here for pre-audit consultations and internal audits to identify gaps.
Challenge 4: Responding to regulatory queries
- Solution: Maintain clear communication channels with CDSCO officials and prepare prompt, documented responses.
Expert Consultation and Support
With over 25 years of experience assisting more than 500 companies, we provide end-to-end CDSCO licensing support tailored to Professional Examination Gown manufacturers and importers. Our services include:
- Gap analysis and regulatory strategy
- Preparation and review of Device and Plant Master Files
- Liaising with testing laboratories and notified bodies
- Application submission and tracking on the CDSCO MD Online Portal
- Handling audit preparation and post-audit compliance
- Expert responses to regulatory queries
Leveraging our expertise minimizes approval risks and expedites market readiness.
Getting Started with Your CDSCO License Application for Professional Examination Gowns
To initiate your licensing journey:
- Determine your license type: Manufacturing requires MD5; importing requires MD15.
- Prepare documentation: Begin compiling your Device Master File, Plant Master File, risk management, and QMS documents.
- Apply for test license (for manufacturing): Submit Form MD13 via the CDSCO MD Online Portal.
- Coordinate product testing: Engage with CDSCO-approved labs early to schedule testing.
- Schedule notified body audit: Contact a notified body from the official list to plan your audit.
- Submit manufacturing/import license application: Complete your application with all supporting documents and fees.
- Monitor application status: Regularly check for updates and respond promptly to queries.
By following these actionable steps and leveraging professional support, manufacturers and importers can successfully obtain their CDSCO licenses for Professional Examination Gowns, ensuring compliance and smooth market entry in India.
