CDSCO License for Electronic Drive Instruments & Accessories
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
The electronic instruments used as orhtopaedic instruemnts. This includes Battery, Battery charger, Tubes for connecting to cuffs, Single cuffs for tourniquet, Double cuffs for tourniquet, High speed Motor control unit, Cutters & Burrs, Straight and Angled Handpieces, Craniotome, Perforator, light source cable, optic fibre cable. The system does not include orthopaedic implants.

Introduction to Electronic Drive Instruments & Accessories and Regulatory Importance
Electronic Drive Instruments & Accessories, especially those used as orthopedic instruments, are critical components in surgical settings. These include batteries, battery chargers, tubes for connecting to cuffs, single and double tourniquet cuffs, high-speed motor control units, cutters, burrs, various handpieces, craniotomes, perforators, light source cables, and optic fiber cables. Importantly, this system excludes orthopedic implants. Given their direct impact on patient safety and surgical outcomes, strict regulatory oversight by the Central Drugs Standard Control Organization (CDSCO) ensures these devices meet high-quality and safety standards before entering the Indian market.
CDSCO Regulatory Framework for Electronic Drive Instruments & Accessories
As per the CDSCO notification 29/Misc./03/2020-DC (193)- Part-3, dated 16.03.2022, Electronic Drive Instruments & Accessories fall under the category of General Hospital or Orthopaedic Instruments. They are classified as Class A medical devices, indicating low risk to patients.
Regulatory compliance involves obtaining the MD5 manufacturing license from the State Licensing Authority, ensuring adherence to the Medical Device Rules, 2017. We have successfully assisted over 500 companies navigating this process, streamlining approvals efficiently.
Risk Classification and License Requirements for Class A Devices
Class A devices, including Electronic Drive Instruments & Accessories, are considered low-risk. This classification requires manufacturers to obtain an MD5 license, filed via Form MD3. The State Licensing Authority governs this process, which typically spans 3 to 4 months, encompassing testing, audit, and final license grant.
Understanding the classification and corresponding license requirements is crucial. For more on device classification, visit our detailed Medical Device Classification guide.
Manufacturing License Process (MD5) for Electronic Drive Instruments & Accessories
Step 1: Obtain Test License (Form MD13)
Manufacturers must first apply for a Test License using Form MD13, which takes approximately 1.5 to 2 months. This license allows for initial manufacturing and testing of the devices.
Step 2: Product Testing
Testing is mandatory and must be performed at CDSCO-approved laboratories. These tests validate the safety and performance of the devices, including electrical safety, biocompatibility, and functional performance. Refer to the Testing Laboratories list for approved labs.
Step 3: Document Preparation
Prepare comprehensive documentation, including Device Master File, Plant Master File, Risk Management File, and Quality Management System (QMS) documents aligned with ISO 13485 standards.
Step 4: Submit MD5 Application (Form MD3)
Submit the application through the CDSCO MD Online Portal, attaching all required documents.
Step 5: Notified Body Audit
A mandatory audit by a notified body verifies compliance with regulatory requirements. Check the list of notified bodies to select an authorized auditor.
Step 6: Query Resolution
Address any queries raised by the State Licensing Authority or the notified body promptly to avoid delays.
Step 7: License Grant
Upon successful audit and clearance of queries, the MD5 manufacturing license is granted via Form MD5.
Manufacturing License Documents Required
For Electronic Drive Instruments & Accessories (Class A), the following documents must be meticulously prepared:
- Company Constitution (Memorandum of Association/Partnership Deed)
- Proof of ownership or lease of manufacturing premises
- Technical staff qualifications and experience documents
- Fire No-Objection Certificate (NOC)
- Pollution Control Board NOC
- Device Master File detailing design, materials, and specifications (Device Master File guide)
- Plant Master File outlining manufacturing facilities and processes (Plant Master File guide)
- Essential Principles Checklist confirming compliance with Medical Device Rules
- Risk Management File demonstrating hazard identification and mitigation (Risk Management guide)
- Test Reports from approved laboratories
- Product labels and Instructions for Use (IFU)
- Quality Management System documentation aligned with ISO 13485
Import License Process (MD15) for Electronic Drive Instruments & Accessories
For importers of Electronic Drive Instruments & Accessories, obtaining the MD15 license from the Central Licensing Authority is mandatory. This process generally takes 5 to 6 months.
Application Steps:
- Prepare all required import documentation, including a valid manufacturing license from the country of origin, Free Sale Certificate, ISO 13485 certification, CE Certificate (if applicable), and device-specific technical files.
- Submit application using Form MD14 via the CDSCO MD Online Portal.
- Address any departmental queries during evaluation.
- Receive the import license in Form MD15.
Documents Required for Import License:
- 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
- Wholesale License
- Company Constitution
Timeline and Processing Duration
Process Stage | Duration (Approx.) |
---|---|
Test License (MD13) | 1.5 – 2 months |
Product Testing | 1 – 1.5 months |
Document Preparation | 2 – 3 weeks |
MD5 Application Processing | 1 – 1.5 months |
Notified Body Audit | 2 – 3 weeks |
Query Resolution | 2 – 3 weeks |
Total Time | 3 – 4 months |
Government Fees and Costs
- Test License (MD13): Included in overall processing
- MD5 License Application Fee: Rs 5,000 per application
- Product Fee: Rs 500 per product
- Notified Body Audit Fees: Variable, typically Rs 50,000 - 1,00,000 depending on scope
Budgeting for these fees upfront ensures smoother financial planning.
Common Challenges and Solutions
Challenge 1: Delays in Document Compilation
- Solution: Engage experienced consultants early to prepare compliant Device and Plant Master Files.
Challenge 2: Testing Failures
- Solution: Pre-assessment testing and quality checks before official lab testing reduce rejections.
Challenge 3: Audit Non-compliance
- Solution: Conduct internal mock audits and gap analyses to ensure readiness for notified body audits.
Challenge 4: Query Resolution Delays
- Solution: Assign dedicated regulatory personnel to respond promptly to queries.
Expert Consultation and Support
With over 25 years of regulatory consulting experience and a successful track record of assisting 500+ companies, we provide end-to-end support for CDSCO licensing of Electronic Drive Instruments & Accessories. Our services include documentation preparation, audit facilitation, product testing coordination, and post-approval compliance.
Getting Started with Your CDSCO License Application
- Evaluate your device classification and confirm Class A status.
- Register your company on the CDSCO MD Online Portal.
- Engage a notified body early to understand audit timelines.
- Initiate Test License (MD13) application to commence product testing.
- Compile all required technical and quality documents with expert guidance.
- Submit your MD5 license application (Form MD3) once testing and documentation are complete.
- Prepare for and schedule the notified body audit.
- Respond promptly to queries from authorities.
By following these practical steps and leveraging expert support, manufacturers of Electronic Drive Instruments & Accessories can efficiently secure their CDSCO licenses and successfully enter the Indian market.
For detailed guidance on the MD5 license process, refer to our comprehensive MD5 License Guide.