CDSCO License for Needle Holder
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
Needle holders intended to secure needles during suturing.
Comprehensive Guide to CDSCO Licensing for Needle Holders (Class A Medical Device)
Needle holders are essential surgical instruments designed to securely hold needles during suturing, playing a critical role in wound closure and patient recovery. Classified under Class A (low risk) devices in India, needle holders fall within the category of General Hospital or Orthopaedic Instruments as per the CDSCO notification 29/Misc./03/2020-DC (193)- Part-3 dated 16.03.2022. Given their medical importance, it is crucial for manufacturers and importers to comply with the Central Drugs Standard Control Organization (CDSCO) regulatory framework to ensure market access and patient safety.
With over 25 years of experience helping more than 500 companies navigate CDSCO licensing, we provide a detailed, step-by-step guide tailored specifically for needle holders to simplify your regulatory journey.
CDSCO Regulatory Framework for Needle Holders
In India, medical devices are regulated under the Medical Device Rules, 2017, governed by CDSCO. Needle holders, as Class A devices, are subject to state-level regulatory oversight under the MD5 licensing pathway. This framework ensures that these low-risk devices meet all safety, quality, and manufacturing standards before they reach healthcare providers.
Manufacturers must obtain a manufacturing license (MD5 license) from the State Licensing Authority, whereas importers require an import license (MD15), issued by the Central Licensing Authority.
Risk Classification and License Requirements for Needle Holders
- Risk Class: Class A (Low Risk)
- License Type for Manufacturing: MD5 License (Form MD3)
- License Authority: State Licensing Authority
- Category: General Hospital or Orthopaedic Instruments
This classification mandates adherence to essential principles and quality management systems appropriate for low-risk medical devices.
Manufacturing License Process (MD5) for Needle Holders
The MD5 license process involves several critical stages:
Test License Application (Form MD13): Before manufacturing, applicants must obtain a test license which allows sample production for testing purposes. This stage takes approximately 1.5 to 2 months.
Product Testing: Needle holders must be tested at CDSCO-approved government laboratories to verify compliance with Indian standards. You can find the list of testing laboratories authorized by the CDSCO.
Document Preparation: Prepare comprehensive documentation including Device Master File (DMF), Plant Master File (PMF), Risk Management File, and Quality Management System (QMS) documents.
Application Submission: File the manufacturing license application on Form MD3 through the CDSCO MD Online Portal.
Audit by Notified Body: A notified body conducts an audit of your manufacturing facility. Refer to the list of notified bodies for eligible auditors.
Query Resolution: Address any queries or deficiencies raised during the document review or audit process promptly.
Grant of License: Upon successful completion of all prior steps, the State Licensing Authority issues the MD5 license (Form MD5).
Manufacturing License Documents Required for Needle Holders
The following documents are essential for the MD5 license application:
- Company Constitution Documents (e.g., Certificate of Incorporation)
- Proof of Ownership or Lease Agreement of Manufacturing Premises
- Details and Qualifications of Technical Staff
- Fire NOC and Pollution Control Board NOC
- Device Master File (DMF) outlining design and manufacturing details (Device Master File Guide)
- Plant Master File (PMF) describing the manufacturing site (Plant Master File Guide)
- Essential Principles Checklist demonstrating compliance with safety and performance standards
- Risk Management File detailing risk assessment and mitigation (Risk Management)
- Test Reports from CDSCO-approved laboratories
- Labels and Instructions for Use (IFU)
- Quality Management System (QMS) documentation, typically ISO 13485:2016 compliant
Import License Process (MD15) for Needle Holders
Although needle holders are low-risk, importers must obtain an MD15 import license from the Central Licensing Authority. The process typically spans 5-6 months and involves:
- Preparation of import documentation including manufacturing license, Free Sale Certificate, ISO 13485:2016 certification, CE Certificate, DMF, PMF, and wholesale license.
- Submission of application via the CDSCO MD Online Portal.
- Review and query resolution by CDSCO.
- Grant of import license (Form MD15).
For detailed guidance, see the Import License Guide.
Timeline and Processing Duration
| Step | Duration |
|---|---|
| Test License (MD13) | 1.5 - 2 months |
| Product Testing | 1 - 1.5 months |
| Document Preparation | 2 - 3 weeks |
| Application Review and Audit | 1 - 1.5 months |
| Query Resolution | 2 - 4 weeks |
| Total Time for MD5 License | 3 - 4 months |
These timelines are approximate and may vary based on application completeness and audit scheduling.
Government Fees and Costs for MD5 License
- Application Fee: Rs 5,000 per application
- Product Fee: Rs 500 per product (needle holder variants)
Additional costs include testing laboratory fees, notified body audit charges, and internal expenses for document preparation and quality system implementation.
Common Challenges and Solutions
Challenge: Delays in product testing due to limited slots at government labs.
Solution: Schedule testing well in advance and consider multiple approved labs for faster turnaround.
Challenge: Incomplete or inconsistent documentation leading to audit queries.
Solution: Engage expert consultants early to prepare thorough DMF, PMF, and risk management files.
Challenge: Non-compliance with essential principles or QMS standards.
Solution: Conduct internal audits and gap assessments before official audits.
Expert Consultation and Support
Navigating CDSCO regulations can be complex, especially with evolving guidelines for medical devices. Our seasoned regulatory consultants have successfully assisted over 500 manufacturers and importers in securing timely approvals for Class A devices like needle holders. We offer end-to-end support including:
- Preparation and review of Device and Plant Master Files
- Risk management implementation
- Coordination with testing laboratories and notified bodies
- Application filing and query handling
Contact us to leverage our expertise and avoid common pitfalls.
Getting Started with Your CDSCO License Application for Needle Holders
Assess Your Manufacturing Setup: Ensure your facility complies with GMP and has qualified technical staff.
Gather Required Documents: Begin compiling company, technical, and quality system documents.
Apply for Test License (Form MD13): Submit your test license application via the CDSCO MD Online Portal.
Plan Product Testing: Coordinate with CDSCO-approved laboratories to schedule product testing.
Prepare for Notified Body Audit: Select an appropriate notified body from the notified bodies list and schedule the audit.
Submit Manufacturing License Application (Form MD3): After successful testing and audit, apply for the MD5 license.
Respond Promptly to Queries: Address any observations from CDSCO or the audit team to avoid delays.
By following these actionable steps and partnering with experienced consultants, you can expedite your needle holder’s entry into the Indian market while ensuring full regulatory compliance.
For further reading, explore our detailed MD5 License Guide.
We are committed to helping you achieve seamless regulatory approvals with transparency, expertise, and personalized support. Reach out to us today to get started!
