CDSCO License for Exothermic heat therapy pack
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
Intended to be applied to the body surface, sometimes with pressure, to provide heat therapy to reduce muscle spasms and cramps and/or for joint and muscle stiffness and pain.
Comprehensive Guide to CDSCO Licensing for Exothermic Heat Therapy Pack (Class A Medical Device)
As regulatory consultants with over 25 years of experience and having successfully guided 500+ companies through the CDSCO licensing maze, we understand the unique challenges faced by manufacturers and importers of Class A medical devices like the exothermic heat therapy pack. This rehabilitation device, intended to provide heat therapy to reduce muscle spasms, cramps, and joint stiffness, falls under the Class A risk category and requires meticulous compliance with the CDSCO regulatory framework. In this detailed guide, we walk you through the exact steps, timelines, costs, and documentation needed to secure your MD5 manufacturing license and smoothly enter the Indian market.
Understanding the CDSCO Regulatory Framework for Exothermic Heat Therapy Packs
The Central Drugs Standard Control Organization (CDSCO) is the apex national regulatory body for medical devices in India. As per the Medical Device Rules 2017 (MDR), devices are classified into four risk classes (A, B, C, D) based on their intended use and potential risk to patients. Your exothermic heat therapy pack is classified as Class A, which are low-risk devices primarily regulated at the State Licensing Authority level.
The regulatory framework mandates obtaining a manufacturing license (MD5) before you can legally manufacture or market your device in India. This ensures your product complies with safety, quality, and performance standards.
Risk Classification and License Requirements for Exothermic Heat Therapy Pack
- Device Name: Exothermic heat therapy pack
- Risk Class: A (Low risk)
- Category: Rehabilitation
- Notification: File No. 29/Misc./03/2020-DC (160), dated 04.08.2022
- Applicable License: MD5 Manufacturing License (Form MD3)
Since this device is Class A, the licensing authority is the State Drug Controller where your manufacturing site is located. The entire licensing process, including test license acquisition, product testing, audit, and final license grant, typically takes 3 to 4 months.
Manufacturing License Process (MD5) for Class A Devices
The MD5 licensing process is systematic and involves several key stages:
Test License (Form MD13): Obtain a test license first, which allows initial product testing and trial manufacturing. This stage typically takes 1.5 to 2 months.
Product Testing: Get your exothermic heat therapy packs tested at CDSCO-approved government laboratories to verify compliance with applicable standards. Refer to the list of testing laboratories for authorized facilities.
Documentation Preparation: Prepare comprehensive documentation including Device Master File, Plant Master File, Quality Management System (QMS) documents, and risk management files.
License Application Submission (Form MD3): Submit your manufacturing license application via the CDSCO MD Online Portal along with the required fees.
Audit by Notified Body: Your manufacturing facility will be audited by a notified body to ensure compliance with MDR requirements. You can check the list of notified bodies authorized to conduct these audits.
Resolution of Queries: Address any queries or observations raised by the licensing authority or notified body promptly.
Grant of License (Form MD5): Upon successful completion of all steps, the MD5 license will be issued, allowing full-scale manufacturing.
Manufacturing License Documents Required for Exothermic Heat Therapy Packs
Assembling a robust documentation package is critical. For your Class A device, the following documents must be submitted:
- Company Constitution (Incorporation Certificate, Memorandum & Articles of Association)
- Proof of Ownership or Lease Agreement of Manufacturing Premises
- Details and qualifications of Technical Staff
- Fire Safety NOC
- Pollution Control Board NOC
- Device Master File (DMF): Detailed specifications, design, and manufacturing process documentation. Our Device Master File guide provides comprehensive insights.
- Plant Master File (PMF): Details about the manufacturing facility, equipment, and quality controls. Learn how to create a compliant PMF here.
- Essential Principles Checklist confirming conformity to regulatory requirements
- Risk Management File demonstrating hazard identification and mitigation strategies (refer to our Risk Management guide)
- Test Reports from CDSCO-approved labs
- Labeling and Instructions for Use (IFU)
- Quality Management System Documents (ISO 13485 certification and SOPs)
Import License Process (MD15) for Exothermic Heat Therapy Packs
If you plan to import the exothermic heat therapy pack into India, you must obtain an Import License (MD15) from the Central Licensing Authority. The process takes approximately 5 to 6 months and involves:
- Preparation of import-related documentation, including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016 certificate, CE Certificate (if applicable), Device Master File, and Plant Master File.
- Submission of application on the CDSCO MD Online Portal.
- Resolution of queries raised by CDSCO.
Note that unlike MD5, no test license is required for import licenses.
Import License Documents Required
- Valid Manufacturing License from the country of origin
- Free Sale Certificate issued by the country of origin
- ISO 13485:2016 certificate
- CE Certificate (if applicable)
- Device Master File & Plant Master File
- Wholesale license (if applicable)
- Company Constitution
Timeline and Processing Duration
| Process Stage | Duration |
|---|---|
| Test License (MD13) | 1.5 – 2 months |
| Product Testing | 1 – 1.5 months |
| Documentation Preparation | Concurrent with testing |
| License Application & Audit | 1 – 1.5 months |
| Query Resolution & Grant | 0.5 – 1 month |
Total Time: Approximately 3 to 4 months for MD5 manufacturing license.
Government Fees and Costs for MD5 License
- Application Fee: Rs. 5,000 per application
- Product Fee: Rs. 500 per product
Additional costs may include notified body audit fees, product testing charges at government labs, and consultancy fees if you opt for external support.
Common Challenges and Solutions
Challenge 1: Delays in Product Testing
- Solution: Engage with CDSCO-approved testing laboratories early and understand their lead times. Submit complete samples with clear labeling and documentation to avoid rejection.
Challenge 2: Incomplete Documentation
- Solution: Use checklists and templates for Device Master File and Plant Master File preparation. Our guides linked above can streamline this process.
Challenge 3: Non-compliance Observations During Audit
- Solution: Conduct internal audits and mock inspections before the notified body audit. Ensure all technical staff are well-trained and quality systems are effectively implemented.
Challenge 4: Query Resolution Delays
- Solution: Assign a dedicated regulatory affairs professional to monitor and promptly respond to queries from CDSCO or notified bodies.
Expert Consultation and Support
Navigating CDSCO licensing can be complex, especially for first-time applicants. With our 25+ years of experience and a track record of over 500 successful CDSCO licenses, we provide end-to-end support:
- Gap analysis and readiness assessment
- Documentation preparation and review
- Liaison with notified bodies and testing labs
- Application submission and query management
- Training for your quality and regulatory teams
Our goal is to minimize your time to market and ensure compliance with minimal hassle.
Getting Started with Your CDSCO License Application for Exothermic Heat Therapy Pack
To initiate your CDSCO MD5 license application, follow these practical steps:
Assess Manufacturing Site Readiness: Ensure your facility meets GMP requirements and has qualified technical staff.
Apply for Test License (MD13): Submit an application via the CDSCO MD Online Portal to obtain the test license.
Coordinate Product Testing: Send samples to CDSCO-approved labs for testing.
Prepare Required Documentation: Assemble your Device Master File, Plant Master File, risk management files, and other required documents.
Schedule Notified Body Audit: Identify and engage a notified body from the official list for your audit.
Submit MD5 License Application: Apply on the CDSCO portal with all supporting documents.
Monitor Application Progress: Respond promptly to any queries from CDSCO or the notified body.
Receive License and Commence Manufacturing: Upon license grant, you can legally manufacture and market your exothermic heat therapy pack in India.
By following these steps and leveraging expert guidance, you can achieve a smooth and timely CDSCO licensing experience for your Class A exothermic heat therapy pack. Contact us today to learn how we can assist you in every phase of this journey.
