CDSCO License for Dissector
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 hand-held surgical instrument, usually spoon shaped or rounded at the working end made of stainless steel, used to separate a soft tissue or body structure from another. It comes in various shapes and sizes but usually has a handle proximally which continues into a shaft as one moves distally. The shaft terminates in a tip which may be pointed or flat, sharp or blunt and angled or straight from the shaft. These include tear drop dissector set & pen field dissector.
Comprehensive Guide to CDSCO Licensing for Dissector Devices (Class A Medical Device)
As a trusted regulatory consultancy with over 25 years of experience and a proven track record assisting 500+ companies, we understand the critical importance of navigating the Central Drugs Standard Control Organization (CDSCO) licensing process efficiently, especially for Class A medical devices like the Dissector. A Dissector is an essential hand-held surgical instrument designed to separate soft tissue or body structures during surgical procedures. Given its classification as a Class A device under the CDSCO Medical Device Rules, manufacturers and importers must comply with specific regulatory requirements to legally market this device in India.
CDSCO Regulatory Framework for Dissector Devices
The Dissector falls under the category of General Hospital or Orthopaedic Instruments and is notified under 29/Misc./03/2020-DC (193)- Part-3 dated 16.03.2022. As a Class A device, it is considered low risk, but compliance with the CDSCO framework remains mandatory to ensure patient safety and regulatory adherence.
Under CDSCO rules, Class A devices are regulated by State Licensing Authorities, requiring an MD5 manufacturing license (Form MD3) and an MD15 import license for imported products. The entire process encompasses product testing, document preparation, audits, and final license issuance.
Risk Classification and License Requirements for Dissector
- Device Name: Dissector
- Risk Class: A (Low Risk)
- Regulatory Pathway: MD5 Manufacturing License (State Authority) and MD15 Import License (Central Authority)
- Key Notifications: 29/Misc./03/2020-DC (193)- Part-3, dated 16.03.2022
Manufacturing License Process (MD5) for Class A Dissector
For Class A devices like the Dissector, the manufacturing license process involves several sequential steps:
Obtain Test License (Form MD13): Before manufacturing, you must secure a test license which typically takes 1.5 to 2 months. This license authorizes the company to manufacture limited quantities for testing.
Product Testing: The Dissector must be tested at CDSCO-recognized government-approved laboratories to evaluate compliance with applicable standards. Refer to the Testing Laboratories list for approved facilities.
Document Preparation: Compile all required documents including Device Master File, Plant Master File, Essential Principles Checklist, Risk Management File, and Quality Management System (QMS) documentation.
Application Submission: Submit the manufacturing license application on Form MD3 through the CDSCO MD Online Portal.
Audit by Notified Body: An audit is conducted by a notified body listed on the Notified Bodies list to verify compliance with manufacturing and quality standards.
Queries and Clarifications: Respond promptly to any queries raised by the licensing authority or notified body.
License Grant: Upon successful audit and document verification, the State Licensing Authority issues the MD5 license.
The entire MD5 process generally takes about 3 to 4 months, including test license acquisition, testing, audit, and licensing.
Manufacturing License Documents Required for Dissector
Successful applications for the Dissector manufacturing license must include:
- Company Constitution Documents (e.g., Memorandum of Association, Partnership Deed)
- Proof of Ownership or Lease Agreement of Manufacturing Premises
- Qualification and Experience Certificates of Technical Staff
- Fire No Objection Certificate (NOC)
- Pollution Control Board NOC
- Device Master File (DMF) detailing design, materials, and specifications (See our Device Master File Guide)
- Plant Master File (PMF) outlining manufacturing facility details (Plant Master File Guide)
- Essential Principles Checklist confirming compliance with Indian regulatory standards
- Risk Management File demonstrating hazard identification and mitigation (Risk Management Guide)
- Test Reports from government-approved laboratories
- Product Labels and Instructions for Use (IFU)
- Quality Management System Documentation (e.g., ISO 13485:2016 certificates, SOPs)
Import License Process (MD15) for Dissector
For importers of the Dissector device, obtaining an MD15 license from the Central Licensing Authority is mandatory. The process involves:
Document Compilation: Prepare relevant documents including the valid manufacturing license, Free Sale Certificate from the country of origin, ISO 13485:2016 certification, CE certificate (if applicable), and other technical dossiers.
Application Submission: File the application on Form MD14 via the CDSCO MD Online Portal.
Queries Resolution: Address any clarifications sought by CDSCO officials.
License Issuance: Upon satisfactory review, the MD15 import license is granted.
The import license process typically takes 5 to 6 months.
Import License Documents Required for Dissector
- Valid Manufacturing License (MD5 or MD9) from the country of manufacture
- Free Sale Certificate issued by the regulatory authority of the country of origin
- ISO 13485:2016 Certification
- CE Certificate (if applicable)
- Device Master File
- Plant Master File
- Wholesale License for distribution
- Company Constitution Documents
Timeline and Processing Duration
| Process Step | Duration |
|---|---|
| Test License (MD13) | 1.5 – 2 months |
| Product Testing | 1 – 1.5 months |
| Document Preparation | 2 – 3 weeks |
| Manufacturing License (MD5) | 1 – 1.5 months |
| Import License (MD15) | 5 – 6 months |
Manufacturers should plan for approximately 3 to 4 months to complete the manufacturing license process and 5 to 6 months for import licensing.
Government Fees and Costs
For Class A Dissector devices, the government fees for licensing are as follows:
- MD5 Manufacturing License: Rs 5000 per application + Rs 500 per product
- Test License (MD13): Included in the application process
- MD15 Import License: Approximately USD 1000 per site + USD 50 per product
Additional costs to consider include testing fees charged by approved laboratories and audit fees payable to notified bodies.
Common Challenges and Solutions
Challenge 1: Delays in obtaining test license and product testing.
Solution: Initiate the test license application early and select government-approved labs with available capacity to avoid bottlenecks.
Challenge 2: Incomplete or inconsistent documentation leading to queries.
Solution: Use comprehensive checklists and expert consultation to ensure all technical and legal documents are complete and accurate.
Challenge 3: Audit non-compliance due to inadequate QMS or facility standards.
Solution: Conduct internal mock audits and ensure ISO 13485 implementation before the official audit.
Challenge 4: Navigating the CDSCO MD Online Portal.
Solution: Familiarize yourself with the portal interface or seek expert assistance for smooth application submission.
Expert Consultation and Support
With our extensive experience assisting over 500 manufacturers and importers, we provide tailored regulatory consulting to streamline your CDSCO licensing journey. From document preparation and gap analysis to audit readiness and query management, our expert team ensures compliance and faster approvals.
Getting Started with Your CDSCO License Application for Dissector
Initial Assessment: Evaluate your manufacturing or import setup against CDSCO requirements.
Document Compilation: Begin preparing the Device Master File, Plant Master File, and QMS documents. Refer to our detailed Device Master File Guide and Plant Master File Guide to streamline this process.
Test License Application: Apply for the MD13 test license via the CDSCO MD Online Portal to initiate product testing.
Product Testing: Coordinate with accredited testing laboratories early to schedule necessary tests.
Audit Preparation: Engage with a notified body from the official Notified Bodies List for your audit.
Final Application: Submit the MD5 manufacturing license application upon successful testing and audit completion.
For importers, compile your import documentation and submit the MD15 application through the same portal.
Embarking on your regulatory journey with expert guidance ensures compliance, reduces delays, and accelerates your Dissector device's access to the Indian healthcare market. Contact us to leverage our 25+ years of expertise and make your CDSCO licensing process seamless and successful.
