CDSCO License for Non-sterile Surgical punch
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 surgical instrument used to create a hole for suturing or anastomosis of a tissue, blood vessel, etc.
Comprehensive Guide to Obtaining CDSCO License for Non-sterile Surgical Punch (Class A Device)
As seasoned regulatory consultants with over 25 years of experience and a proven track record of assisting more than 500 companies, we understand the complexities and nuances involved in securing CDSCO licenses for medical devices in India. This guide specifically addresses the regulatory requirements for the Non-sterile Surgical Punch—a Class A medical device widely used in operation theatres for creating precise holes in tissues or blood vessels during procedures.
Understanding the Non-sterile Surgical Punch and Its Regulatory Importance
The Non-sterile Surgical Punch is a critical surgical instrument designed for making holes to facilitate suturing or anastomosis of tissues and blood vessels. Given its direct application in invasive procedures, regulatory oversight by the Central Drugs Standard Control Organization (CDSCO) ensures that manufacturers and importers maintain stringent quality, safety, and efficacy standards before placing these devices in the Indian market.
CDSCO Regulatory Framework for Non-sterile Surgical Punch
This device falls under the operation theatre category and is classified as a Class A medical device under the CDSCO regulatory system. The specific notification governing this device is File No. 29/Misc/03/2020-DC (199), dated 13.9.2021. This classification places the Non-sterile Surgical Punch in the lowest risk category, but compliance with all regulatory norms remains mandatory.
Risk Classification and License Requirements
- Risk Class: A (Low Risk)
- Applicable License: MD5 Manufacturing License
- Regulatory Authority: State Licensing Authority
Manufacturers of Class A devices must obtain an MD5 license under Form MD3 to legally manufacture and market these devices in India. This license confirms adherence to prescribed manufacturing practices and ensures device safety.
Detailed Manufacturing License Process (MD5)
The manufacturing license process for Class A devices like the Non-sterile Surgical Punch involves several sequential steps:
Test License Acquisition (Form MD13): The initial step requires obtaining a test license which generally takes around 1.5 to 2 months. This license allows you to manufacture a limited quantity for testing purposes.
Product Testing: After acquiring the test license, samples must be tested at government-approved laboratories to validate compliance with applicable standards. You can refer to the list of approved testing laboratories for this purpose.
Documentation Preparation: Prepare comprehensive technical documentation including Device Master File and Plant Master File. Our Device Master File guide and Plant Master File guide provide step-by-step instructions.
License Application Submission: Apply for the MD5 license using Form MD3 through the CDSCO MD Online Portal.
Audit by Notified Body: A notified body, listed on the CDSCO Notified Bodies List, will conduct a thorough audit of your manufacturing site and quality systems.
Query Resolution: Address any queries or deficiencies raised by the licensing authority or the notified body promptly.
Grant of License: Upon satisfactory compliance, the license is granted on Form MD5.
Manufacturing License Documents Required
To ensure a smooth application process, have the following documents ready:
- Company Constitution/Registration Certificate
- Proof of ownership or valid lease agreement for manufacturing premises
- Technical staff qualifications and experience certificates
- Fire No Objection Certificate (NOC)
- Pollution Control Board NOC
- Device Master File detailing product specifications, manufacturing processes, and testing protocols
- Plant Master File describing manufacturing facilities and quality control systems
- Essential Principles Checklist demonstrating compliance with safety and performance standards
- Risk Management File reflecting risk assessment and mitigation strategies
- Product Test Reports from government-approved labs
- Labels and Instructions for Use (IFU)
- Quality Management System (QMS) documentation, preferably ISO 13485 certified
Import License Process (MD15) for Non-sterile Surgical Punch
While our focus here is on manufacturing, importers must apply for the MD15 import license via Form MD14 on the CDSCO portal. This process typically takes 5-6 months and requires additional documents such as a Free Sale Certificate, CE certification, and wholesale license.
For import-related details, our Import License guide offers comprehensive assistance.
Timeline and Processing Duration
| Step | Duration |
|---|---|
| Test License (MD13) | 1.5 to 2 months |
| Product Testing | 2 to 3 weeks |
| Document Preparation | 2 to 4 weeks |
| Application Submission & Audit | 1 to 1.5 months |
| Query Resolution & License Grant | 2 to 3 weeks |
| Total Estimated Duration | 3 to 4 months |
Government Fees and Costs
- Test License Fee (MD13): Rs. 5,000
- MD5 License Application Fee: Rs. 5,000 per application
- Product Fee: Rs. 500 per product
Budgeting for these fees upfront will help avoid delays.
Common Challenges and Practical Solutions
Challenge: Delays in obtaining test reports due to lab backlogs
- Solution: Pre-book testing slots with accredited labs and submit samples early.
Challenge: Incomplete technical documentation
- Solution: Utilize our detailed Device Master File guide to ensure all sections are comprehensively covered.
Challenge: Non-compliance findings during notified body audit
- Solution: Conduct pre-audit internal assessments and implement corrective actions before the official audit.
Challenge: Misunderstanding regulatory timelines
- Solution: Maintain consistent communication with the CDSCO authority and track application status on the CDSCO MD Online Portal.
Expert Consultation and Support
Navigating the CDSCO licensing landscape can be daunting, especially with evolving regulations. Our extensive experience in handling over 500 successful CDSCO licenses positions us to offer tailored support including:
- Detailed gap assessments
- Document drafting and review
- Liaison with notified bodies and CDSCO officials
- Training for your technical and regulatory teams
Engaging expert consultants not only expedites the process but also mitigates risks of application rejection.
Getting Started with Your CDSCO License Application for Non-sterile Surgical Punch
Assess Your Device Classification: Confirm Class A status using the Medical Device Classification reference.
Initiate Test License Application: Prepare and submit Form MD13 through the CDSCO MD Online Portal.
Select Approved Testing Laboratory: Identify and coordinate with a government-approved test lab for your product samples.
Compile Required Documentation: Leverage our guides to prepare robust Device and Plant Master Files.
Schedule Notified Body Audit: Contact a notified body early to align audits with your timeline.
Submit MD5 License Application: Complete Form MD3 submission once all prerequisites are met.
Prepare for Queries and Compliance Checks: Stay responsive to any follow-up from CDSCO or the notified body.
By following these actionable steps and leveraging expert resources, manufacturers can confidently navigate the CDSCO licensing process for the Non-sterile Surgical Punch and successfully enter the Indian market with compliance and quality assurance.
