CDSCO License for Paediatric urine collection/analysis kit
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 collection of devices intended to be used to collect and analyse a paediatric urine specimen for multiple clinical chemistry analytes (e.g., ketones, glucose and pH). It consists of a specimen collection undergarment (nappy or diaper) worn by the patient, and quantitative test strips for various clinical chemistry analytes. Results are analysed visually or with dedicated interpretive software (not included). It is intended to be used at the point-of-care by a healthcare professional, or at home by a caregiver. This is a single-use device.
Comprehensive Guide to CDSCO Licensing for Paediatric Urine Collection/Analysis Kit (Class A Medical Device)
When introducing a paediatric urine collection and analysis kit to the Indian market, understanding the regulatory landscape is crucial. This device, classified as Class A, is designed for single-use collection and quantitative analysis of paediatric urine specimens, aiding healthcare professionals and caregivers in point-of-care or home settings. With our 25+ years of experience assisting over 500 companies in obtaining CDSCO licenses, we provide a detailed, practical roadmap to help you efficiently secure your manufacturing or import license.
CDSCO Regulatory Framework for Paediatric Urine Collection/Analysis Kits
The Central Drugs Standard Control Organization (CDSCO) governs medical device registration and licensing in India. Since August 2020, CDSCO regulates medical devices under a risk-based classification system aligned with global best practices. Your paediatric urine collection kit falls under Class A, the lowest risk category, governed primarily by State Licensing Authorities.
The device is notified under File No. 29/MiscJ03/2020-DC (150) dated 23.8.2021, ensuring its regulatory recognition. Compliance with CDSCO’s essential principles, quality management systems, and testing requirements is mandatory prior to market entry.
Risk Classification and License Requirements
Paediatric urine collection/analysis kits are Class A devices due to their low risk profile. For manufacturers, this means applying for an MD5 Manufacturing License using Form MD3 through the State Licensing Authority. Importers similarly must follow the import license process but note that import licenses for Class A devices are granted by the Central Licensing Authority.
Manufacturing License Process (MD5) for Class A Devices
The manufacturing license process involves several sequential steps:
Test License (Form MD13): Before the full license, apply for a test license to enable product testing. This phase generally takes 1.5 to 2 months.
Product Testing: Testing must be conducted at CDSCO-approved laboratories to ensure compliance with Indian standards. You can find the list of notified testing laboratories on the CDSCO portal.
Document Preparation: Assemble all required documents including technical files, quality management systems, and risk management documentation.
Application Submission (Form MD3): Submit your manufacturing license application via the CDSCO MD Online Portal.
Audit by Notified Body: A mandatory audit by a notified body verifies compliance with Good Manufacturing Practices (GMP). Refer to the current notified bodies list.
Query Resolution: Address any concerns or clarifications raised by the licensing authority or notified body.
Grant of License (Form MD5): Upon successful review and audit, the manufacturing license is issued.
Manufacturing License Documents Required
For your paediatric urine collection kit, ensure you have the following:
- Company Constitution and Incorporation Certificate
- Proof of ownership or lease of manufacturing premises
- Details and qualifications of technical staff
- Fire and Pollution No Objection Certificates (NOCs)
- Device Master File (DMF) detailing design, specifications, and manufacturing process (Device Master File Guide)
- Plant Master File describing manufacturing facilities and equipment (Plant Master File Guide)
- Essential Principles Compliance Checklist
- Risk Management File demonstrating hazard analysis and mitigation (Risk Management Guide)
- Product Test Reports from CDSCO-approved labs
- Product Labels and Instructions for Use (IFU)
- Quality Management System (QMS) documentation, typically ISO 13485 compliant
Import License Process (MD15) for Paediatric Urine Collection Kits
If you intend to import the device, the process is managed by the Central Licensing Authority with the following steps:
Document Preparation: Compile the necessary documents including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485 certification, CE certificate, and technical files.
Application Submission (Form MD14): Submit the import license application via the CDSCO MD Online Portal.
Query Resolution: Respond promptly to any queries raised by CDSCO officials.
Grant of License (Form MD15): Upon satisfactory review, the import license is granted.
Import licenses typically take 5 to 6 months to process.
Import License Documents Required
- Valid Manufacturing License from the exporting country
- Free Sale Certificate confirming market authorization abroad
- ISO 13485:2016 Certificate
- CE Certificate or equivalent
- Device Master File and Plant Master File
- Wholesale Drug License (if applicable)
- Company Constitution and other corporate documents
Timeline and Processing Duration
| License Type | Processing Time |
|---|---|
| Test License (MD13) | 1.5 to 2 months |
| Manufacturing License (MD5) | 3 to 4 months (including test license and audit) |
| Import License (MD15) | 5 to 6 months |
Timely and accurate application submission, along with prompt responses to queries, significantly impact these timelines.
Government Fees and Costs
For Class A devices like the paediatric urine collection kit, the fee structure is as follows:
- MD5 Manufacturing License: Rs 5,000 per application plus Rs 500 per product
- Test License (MD13): Included as part of the process, no separate fee
- Import License (MD15): USD 1,000 per site plus USD 50 per product
These fees are payable online through the CDSCO portal during application.
Common Challenges and Solutions
- Incomplete Documentation: Many applicants face delays due to missing or insufficient documents. We recommend a thorough checklist review before submission.
- Delayed Testing: Testing in government-approved labs can be time-consuming. Initiate sample submission early and consider multiple labs to avoid bottlenecks.
- Audit Non-compliance: Ensure your QMS and manufacturing processes comply fully with CDSCO GMP requirements to avoid audit failures.
Our experience shows proactive engagement with notified bodies and early preparation of risk management and essential principles documentation can mitigate these issues.
Expert Consultation and Support
Navigating CDSCO licensing can be complex, especially with evolving regulatory requirements. Our team has guided over 500 companies through successful registrations by offering:
- Pre-application gap analysis
- Documentation preparation and review
- Coordination with notified bodies and testing labs
- Audit readiness and QMS optimization
Partnering with experienced consultants accelerates your path to market while ensuring compliance and minimizing risk.
Getting Started with Your CDSCO License Application
- Identify Your Device Classification: Confirm your paediatric urine collection kit as Class A.
- Prepare Documentation: Start compiling your Device Master File, Plant Master File, Risk Management File, and QMS documents.
- Apply for Test License: Submit Form MD13 via the CDSCO MD Online Portal to initiate product testing.
- Select Testing Laboratory: Choose from CDSCO-approved labs to conduct your product tests.
- Schedule Audit: Coordinate with notified bodies early to plan your GMP audit.
- Submit Manufacturing License Application: After successful testing and audit, apply for your MD5 license.
By following these steps methodically and leveraging expert guidance, manufacturers and importers can efficiently bring paediatric urine collection and analysis kits to the Indian healthcare market with full regulatory compliance.
