CDSCO License for Medical/Cadaver Body Bags
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 for transporting a human corpse without any spread of biohazard/infectious agent.

Introduction to Medical/Cadaver Body Bags and Their Regulatory Importance
Medical/Cadaver Body Bags are specialized personal protective equipment (PPE) designed for the safe and hygienic transportation of human corpses, ensuring no spread of biohazard or infectious agents. Their critical role in healthcare and mortuary settings demands strict adherence to regulatory standards to guarantee safety and efficacy.
In India, the Central Drugs Standard Control Organization (CDSCO) regulates these devices under Risk Class A, reflecting their low-risk classification but essential compliance requirements. Obtaining the correct CDSCO license ensures your Medical/Cadaver Body Bags meet Indian regulatory standards, enabling lawful manufacturing and marketing.
With over 25 years of experience and having assisted 500+ companies in securing CDSCO licenses, we provide clear, actionable insights on the regulatory pathway for Medical/Cadaver Body Bags.
CDSCO Regulatory Framework for Medical/Cadaver Body Bags
Medical/Cadaver Body Bags fall under the category of Personal Protective Equipment (PPE) and are notified under File No. 29/Misc./03/2020-DC (186) dated 13.9.2021. As per the CDSCO framework, these devices are classified as Class A — the lowest risk category, according to the Medical Device Rules (MDR) 2017.
Class A devices require a manufacturing license from the State Licensing Authority via the MD5 license process. The regulatory steps include obtaining a test license, product testing, audit of manufacturing premises, and final license issuance.
For comprehensive classification details, you can refer to our Medical Device Classification guide.
Risk Classification and License Requirements for Medical/Cadaver Body Bags
- Risk Class: A (Low Risk)
- License Type: MD5 Manufacturing License (Form MD3)
- Licensing Authority: State Licensing Authority
- Applicable Regulations: Medical Device Rules (MDR) 2017
This classification simplifies the process but still requires strict compliance with quality and safety standards.
Manufacturing License Process (MD5) for Medical/Cadaver Body Bags
The MD5 license process for Class A Medical/Cadaver Body Bags involves the following key steps:
Apply for Test License (Form MD13): Before manufacturing, you must obtain a test license, which allows you to manufacture a limited quantity for testing and evaluation. This step generally takes 1.5 to 2 months.
Product Testing: Conduct testing of the Medical/Cadaver Body Bags at CDSCO-approved government laboratories to verify safety parameters. Refer to the list of testing laboratories for authorized centers.
Prepare Documentation: Compile all necessary documents including Device Master File (DMF), Plant Master File (PMF), Essential Principles Checklist, Risk Management File, and Quality Management System (QMS) documents.
Submit Manufacturing License Application (Form MD3): Apply via the CDSCO MD Online Portal with all supporting documents.
Audit by Notified Body: A notified body will conduct an audit of your manufacturing facility to ensure compliance. You can check the list of notified bodies authorized for this purpose.
Resolve Queries: Respond promptly to any queries raised by the licensing authority or notified body.
License Grant: Upon successful audit and document verification, the MD5 license will be granted.
Manufacturing License Documents Required for MD5
For Medical/Cadaver Body Bags, the following documents are essential:
- Company Constitution (e.g., Incorporation Certificate, Partnership Deed)
- Proof of Ownership or Lease Agreement of Manufacturing Premises
- Details of Technical Staff (Qualifications & Experience)
- Fire NOC and Pollution Control Board NOC
- Device Master File (DMF): Detailed technical documentation of the device. Our Device Master File guide can help you prepare this.
- Plant Master File (PMF): Information about manufacturing facilities. Learn more from our Plant Master File guide.
- Essential Principles Checklist demonstrating conformity to regulatory requirements
- Risk Management File addressing potential hazards and mitigation strategies. We recommend reviewing our Risk Management resource.
- Product Test Reports from CDSCO-approved laboratories
- Product Labels and Instructions for Use (IFU)
- Quality Management System (QMS) Documents (e.g., ISO 13485 certification)
Import License Process (MD15) for Medical/Cadaver Body Bags
If you are an importer looking to bring Medical/Cadaver Body Bags into India, you must obtain an MD15 Import License from the CDSCO Central Licensing Authority.
The process includes:
Document Preparation: Compile documents such as a valid Manufacturing License from the country of origin, Free Sale Certificate, ISO 13485 certification, CE Certificate if applicable, Device and Plant Master Files, Wholesale License, and Company Constitution.
Submit Application (Form MD14): Apply via the CDSCO MD Online Portal.
Queries Resolution: Address any clarifications requested by CDSCO.
License Grant: Upon document approval, the import license (Form MD15) will be issued.
Import License Documents Required for MD15
- Manufacturing License from the country of origin
- Free Sale Certificate
- ISO 13485:2016 Certificate
- CE Certificate (if applicable)
- Device Master File
- Plant Master File
- Wholesale License
- Company Constitution
Timeline and Processing Duration
Step | Duration |
---|---|
Test License (MD13) | 1.5 to 2 months |
Product Testing | 2 to 3 weeks |
Document Preparation | Varies (typically 2-4 weeks) |
Application Processing | 1 to 1.5 months |
Audit and License Grant | 2 to 3 weeks |
Total estimated time: Approximately 3 to 4 months for manufacturing license (MD5).
For import license (MD15), the process may take 5 to 6 months.
Government Fees and Costs
MD5 Manufacturing License:
- Application Fee: Rs. 5,000 per application
- Product Fee: Rs. 500 per product
Test License (MD13): Fees included in the overall process
MD15 Import License: Fees vary by class; for Class A devices, approximately 50 per product.
Note that these fees are subject to change; always verify the latest fee structure on the CDSCO MD Online Portal.
Common Challenges and Solutions
Delayed Testing Reports: To avoid bottlenecks, schedule product testing well in advance and maintain close communication with testing laboratories.
Incomplete Documentation: Use templates from our Device Master File guide and Plant Master File guide to ensure thorough documentation.
Audit Non-Compliance: Prepare your facility according to notified body guidelines available on the Notified Bodies List. Conduct internal mock audits to identify gaps.
Query Resolution Delays: Respond promptly and comprehensively to CDSCO queries to prevent delays.
Expert Consultation and Support
Navigating CDSCO licensing can be complex, especially for first-time manufacturers or importers. Our seasoned regulatory consultants have successfully guided over 500 companies through the entire licensing journey for Medical/Cadaver Body Bags and similar Class A devices.
We offer tailored support including:
- Gap analysis of existing documentation
- Assistance in preparation of Device and Plant Master Files
- Coordination with testing laboratories and notified bodies
- Application submission and query management
- Post-approval compliance support
Getting Started with Your CDSCO License Application for Medical/Cadaver Body Bags
Assess Your Device Classification: Confirm Classification as Class A for your Medical/Cadaver Body Bags.
Gather Preliminary Documents: Begin compiling company constitution, premises proofs, and staff qualifications.
Apply for Test License (MD13): Submit your test license application through the CDSCO MD Online Portal to start manufacturing limited units for testing.
Schedule Product Testing: Contact CDSCO-approved laboratories early to avoid delays.
Prepare Comprehensive Documentation: Utilize our detailed Device Master File and Plant Master File guides to streamline document preparation.
Apply for MD5 License: Once testing is complete and documents are ready, submit your manufacturing license application.
Prepare for Audit: Coordinate with a notified body from the official list and ensure your facility meets all compliance requirements.
Starting early and following these steps methodically will position your company for a smooth CDSCO licensing experience, paving the way for successful manufacture or import of Medical/Cadaver Body Bags in India.
For professional assistance or to discuss your specific project, please contact us to leverage our 25+ years of regulatory expertise.