CDSCO License for Non-sterile Staple remover

Comprehensive Guide to CDSCO Licensing for Non-sterile Staple Remover (Class A Medical Device)

As specialists with over 25 years in medical device regulatory consulting, we have successfully guided more than 500 companies through the complexities of obtaining CDSCO licenses in India. This detailed resource focuses on the Non-sterile Staple Remover, a Class A operation theatre device used for safely removing surgical staples. Understanding the regulatory framework, timelines, costs, and documentation requirements is critical for manufacturers and importers aiming to launch this device in the Indian market.

Understanding the Non-sterile Staple Remover and Regulatory Importance

The Non-sterile Staple Remover is a surgical instrument designed to remove metal or plastic staples from wounds or incisions once staple retention is no longer necessary. Categorized under operation theatre devices, it’s classified as a Class A medical device according to CDSCO’s risk classification, reflecting its low risk but important safety profile.

Obtaining a CDSCO license ensures compliance with India’s regulatory standards, helping you avoid legal pitfalls, delays, and costly rejections. It also builds trust with healthcare providers and end-users by affirming device safety and quality.

CDSCO Regulatory Framework for Non-sterile Staple Remover

Since the device falls under Class A, it requires an MD5 manufacturing license granted by the State Licensing Authority. The licensing process involves a test license phase, product testing at government-approved labs, document submission, and an audit by a notified body.

The key regulatory reference is the Medical Devices Rules, 2017, under which this device is notified with File No. 29/Misc/03/2020-DC (199) dated 13.9.2021.

Risk Classification and License Requirements for Non-sterile Staple Remover

Class A devices like the Non-sterile Staple Remover are considered low risk. The regulatory requirements are:

License Type: MD5 Manufacturing License
Application Form: MD3
Licensing Authority: State Licensing Authority
Total Process Duration: Approximately 3-4 months
Relevant Compliance: Testing, audit, and documentation as per CDSCO guidelines

For more about device risk classification, refer to our Medical Device Classification guide.

Manufacturing License Process (MD5) for Non-sterile Staple Remover

The process to obtain an MD5 license involves several critical steps:

Test License Application (Form MD13): Submit an application for a test license to manufacture and test your Non-sterile Staple Remover. This phase takes approximately 1.5 to 2 months.
Product Testing: Conduct mandatory testing at government-approved laboratories to ensure compliance with Indian standards. You can check the list of approved labs here.
Document Preparation: Prepare comprehensive documentation including Device Master File, Plant Master File, risk management, and quality management system documents.
License Application (Form MD3): Apply for the MD5 license through the CDSCO MD Online Portal.
Audit by Notified Body: Undergo an audit from a notified body listed here.
Query Resolution: Respond promptly to any queries raised by the department or audit team.
License Granting: Upon successful completion, the license is issued on Form MD5.

Manufacturing License Documents Required for Non-sterile Staple Remover

Prepare the following essential documents for a smooth application process:

Company Constitution (Incorporation Certificate, Memorandum & Articles of Association)
Proof of ownership or lease agreement of manufacturing premises
Qualification and experience certificates of technical staff
Fire NOC and Pollution Control Board NOC
Detailed Device Master File outlining design, specifications, and manufacturing processes (See our Device Master File guide)
Plant Master File describing manufacturing facilities and equipment (Plant Master File guide)
Essential Principles Checklist confirming compliance with safety and performance requirements
Risk Management File demonstrating hazard identification and mitigation (Risk Management guide)
Test Reports from approved testing laboratories
Product Labels and Instructions for Use (IFU)
Quality Management System documents (typically ISO 13485 compliant)

Import License Process (MD15) for Non-sterile Staple Remover

If you are an importer, the MD15 license is mandatory. The process includes:

Document preparation including Manufacturing License, Free Sale Certificate, ISO 13485:2016, CE Certificate, Device Master File, Plant Master File, Wholesale License, and Company Constitution
Submission of application on Form MD14 via the CDSCO MD Online Portal
Review and resolution of queries
License issuance on Form MD15

The MD15 license process takes approximately 5-6 months. Import fees vary by risk class, with Class A devices incurring $1000 per site and$ 50 per product.

For a detailed import license overview, visit our Import License guide.

Timeline and Processing Duration

Stage	Duration (Approx.)
Test License (MD13)	1.5 – 2 months
Product Testing	2 – 4 weeks
Document Preparation	2 – 4 weeks
License Application & Audit	4 – 6 weeks
Query Resolution & Grant	2 – 4 weeks

Total: 3 to 4 months for MD5 manufacturing license

Government Fees and Costs

Test License (MD13): Included in application process
MD5 Manufacturing License:
- Rs 5000 per application
- Rs 500 per product (for Non-sterile Staple Remover)

Additional indirect costs may include testing fees at government labs, notified body audit fees, and consultancy charges if applicable.

Common Challenges and Solutions

Challenge 1: Delays in test license approval or product testing

Solution: Engage with notified bodies and testing labs early. Maintain proactive communication to avoid bottlenecks.

Challenge 2: Incomplete documentation leading to query escalations

Solution: Use our comprehensive document checklists and templates to ensure completeness.

Challenge 3: Audit non-compliance due to inadequate QMS or risk management

Solution: Implement ISO 13485 and robust risk management practices early. Refer to our Risk Management guide.

Expert Consultation and Support

Navigating CDSCO licensing can be complex, especially for first-time applicants or those unfamiliar with Indian regulatory nuances. Our expert consultants have a proven track record of helping over 500 companies secure licenses efficiently.

We offer:

Gap analysis of your current compliance status
End-to-end documentation support
Coordination with notified bodies and government authorities
Training on regulatory updates and compliance best practices

Getting Started with Your CDSCO License Application

Assess Your Device Classification: Confirm that the Non-sterile Staple Remover is Class A using CDSCO guidelines.
Compile Required Documents: Begin gathering all necessary files including your Device and Plant Master Files.
Apply for Test License: Submit Form MD13 via the CDSCO MD Online Portal.
Schedule Product Testing: Arrange testing at an approved laboratory to obtain compliance reports.
Prepare for Audit: Engage a notified body early to schedule your audit.
Submit MD5 License Application: Apply through the online portal using Form MD3.
Respond to Queries Promptly: Maintain timely communication to expedite licensing.

By following these practical steps and leveraging our regulatory expertise, manufacturers and importers can successfully navigate the CDSCO licensing process for the Non-sterile Staple Remover and secure timely market access in India.

For personalized support or detailed consultation, reach out to our team and ensure your regulatory journey is smooth and compliant.

CDSCO License for Non-sterile Staple remover

Medical Device Information

Important Notice for Class A Devices

Intended Use