CDSCO License for Grasping and Holding Surgical instruments

Comprehensive Guide to CDSCO Licensing for Grasping and Holding Surgical Instruments (Class A)

Grasping and holding surgical instruments are vital tools in the surgical suite, designed for transient invasive use to grasp or hold tissue and blood vessels during procedures. These instruments, featuring serrated or non-serrated tips, fall under Class A—low risk—medical devices according to the CDSCO classification. Navigating the regulatory framework for these devices ensures compliance, safety, and timely market entry in India.

With over 25 years of experience assisting more than 500 companies in securing CDSCO licenses, we provide detailed, practical guidance for manufacturers and importers of these surgical instruments.

CDSCO Regulatory Framework for Grasping and Holding Surgical Instruments

The Central Drugs Standard Control Organization (CDSCO) regulates medical devices in India under the Medical Device Rules, 2017. Since the notification dated 9.9.2022 (F. No. 29/Misc./03/2022-DC (228)), grasping and holding surgical instruments are officially categorized as Class A devices under the surgical instruments category.

This classification determines the licensing pathway, documentation, and regulatory authority involved. For Class A surgical instruments, the State Licensing Authority issues the manufacturing license under the MD5 license framework.

Risk Classification and License Requirements

Device Risk Class: Class A (Low Risk)

Class A devices like grasping and holding surgical instruments require an MD5 license (manufacturing license) applied using Form MD3 through the respective State Licensing Authority. The process includes obtaining a test license (Form MD13), product testing, audit by a notified body, and finally, license grant.

For importers, an MD15 import license from the Central Licensing Authority is required.

Understanding these classifications and required licenses is crucial to ensure compliance and avoid regulatory delays.

Manufacturing License Process (MD5) for Class A Devices

The manufacturing license for Class A devices such as grasping and holding surgical instruments involves the following sequential steps:

Application for Test License (Form MD13): Required before the manufacturing license application, this allows sample testing and takes approximately 1.5 to 2 months.
Product Testing: Conducted at government-approved laboratories to verify safety and performance. Testing labs can be identified via the CDSCO Testing Laboratories list.
Documentation Preparation: Compilation of the Device Master File, Plant Master File, Quality Management System (QMS) documents, and other regulatory documents.
Submit Manufacturing License Application (Form MD3): Filed online through the CDSCO MD Online Portal.
Audit by Notified Body: An audit by an authorized notified body ensures compliance with manufacturing practices. Check the list of notified bodies for audit assignments.
Resolution of Queries: Address any queries or observations from the CDSCO or notified body.
Grant of MD5 License: Upon satisfactory completion, the license is granted on Form MD5.

The entire process typically takes 3 to 4 months, including test license issuance, testing, audit, and final approval.

Manufacturing License Documents Required

For grasping and holding surgical instruments, the following documents are essential to support the MD5 license application:

Company Constitution Documents: Incorporation certificate, partnership deed, or equivalent.
Proof of Ownership or Tenancy of Manufacturing Premises: Lease agreement or ownership documents.
Technical Staff Details: Qualification and experience certificates of the qualified technical personnel.
Fire NOC and Pollution Control Board NOC: Certificates ensuring compliance with safety and environmental norms.
Device Master File: Detailed specifications, design, manufacturing process, and risk management documentation. Our Device Master File guide provides comprehensive insights.
Plant Master File: Information about the manufacturing facility, equipment, and quality control systems. Learn more from our Plant Master File guide.
Essential Principles Checklist: Compliance matrix aligning with regulatory requirements.
Risk Management File: Documentation of risk analysis and mitigation strategies. Refer to our Risk Management guide.
Test Reports: Certificates from government-approved labs validating product safety and efficacy.
Labels and Instructions for Use (IFU): Samples demonstrating compliance with labeling regulations.
Quality Management System Documentation: ISO 13485 certification and internal quality manuals.

Ensuring these documents are detailed and accurate significantly smooths the approval process.

Import License Process (MD15)

For companies importing grasping and holding surgical instruments into India, an MD15 import license is mandatory, obtained from the Central Licensing Authority.

Process Overview:

Document Preparation: Includes manufacturing license of the foreign manufacturer, Free Sale Certificate, ISO 13485:2016 certificate, CE Certificate, Device and Plant Master Files, wholesale license, and company constitution documents.
Application Submission: Submit Form MD14 online via the CDSCO MD Online Portal.
Departmental Review and Queries: Respond to any clarifications or requests.
Grant of Import License (Form MD15): Once satisfied, CDSCO grants the import license.

The MD15 import license process generally takes 5 to 6 months.

Import License Documents Required

Key documents for MD15 application include:

Manufacturing license of the foreign manufacturer
Free Sale Certificate from the country of origin
ISO 13485:2016 certification
CE Certificate (if applicable)
Device Master File
Plant Master File
Wholesale license for distribution
Company constitution and ownership proof

Careful preparation of these documents expedites the approval process.

Timeline and Processing Duration

Process Step	Duration
Test License (MD13)	1.5 to 2 months
Product Testing	2 to 4 weeks
Documentation Preparation	Variable (2-4 weeks recommended)
Manufacturing License Application (MD3)	Immediate submission after docs ready
Audit by Notified Body	3 to 6 weeks
Query Resolution	2 to 4 weeks
Final License Grant (MD5)	Total 3 to 4 months

For import licenses (MD15), anticipate 5 to 6 months due to central authority processing.

Government Fees and Costs

For Class A Grasping and Holding Surgical Instruments:

MD5 Manufacturing License:
- Application fee: Rs. 5,000
- Per product fee: Rs. 500
Test License (MD13): No separate fee but included in overall process costs.
Import License (MD15):
- Site fee: $1,000
- Per product fee: $50

Additional costs may include audit fees charged by notified bodies and testing charges by laboratories.

Common Challenges and Solutions

Challenge 1: Delays in Product Testing

Solution: Select government-approved labs with shorter turnaround times and submit complete samples to avoid retesting. Refer to the CDSCO Testing Laboratories list for reliable options.

Challenge 2: Incomplete Documentation

Solution: Use comprehensive checklists and consult guides like our Device Master File and Plant Master File resources to prepare accurate, complete submissions.

Challenge 3: Audit Non-Compliance

Solution: Conduct internal audits and pre-audit assessments. Engage with notified bodies early and clarify expectations. Check the list of notified bodies to select experienced auditors.

Challenge 4: Query Resolution Delays

Solution: Assign dedicated regulatory personnel to respond promptly and thoroughly to CDSCO queries. Maintain clear communication and document trail.

Expert Consultation and Support

Navigating CDSCO licensing, especially for Class A surgical instruments, can be complex. With our 25+ years of expertise and a proven track record assisting 500+ companies, we offer tailored consultancy services including:

Gap analysis and readiness assessment
Documentation preparation and review
Coordination with notified bodies and testing labs
Application submission and follow-up
Post-approval compliance assistance

Our goal is to simplify your regulatory journey and ensure a fast, hassle-free license grant.

Getting Started with Your CDSCO License Application

Assess Device Classification: Confirm your instrument is Class A per the official CDSCO notification dated 9.9.2022.
Prepare Documentation: Assemble company constitution, proof of premises, technical staff details, and technical files (Device and Plant Master Files).
Apply for Test License (MD13): Submit your application via the CDSCO MD Online Portal.
Coordinate Product Testing: Arrange for timely testing at approved labs.
Compile Final Application (Form MD3): After successful testing, submit your manufacturing license application online.
Engage with Notified Body: Schedule and prepare for the audit.
Respond to Queries Promptly: Keep communication active with CDSCO and notified bodies.
Obtain MD5 License: Begin manufacturing legally after license grant.

For importers, begin with gathering foreign manufacturer documentation and initiating the MD15 license process similarly.

Contact us today to leverage our expertise and streamline your CDSCO licensing for grasping and holding surgical instruments. Our professional support ensures you meet all regulatory requirements efficiently, enabling you to focus on delivering quality surgical devices to the Indian healthcare market.