CDSCO License for Insertion and removal instruments
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
Reusable surgical instruments to facilitate the manipulation, implantation and removal of various orthopaedic devices during orthopaedic surgeries.
Comprehensive Guide to CDSCO Licensing for Insertion and Removal Instruments (Class A Medical Devices)
Insertion and removal instruments play a crucial role in orthopaedic surgeries by enabling precise manipulation, implantation, and extraction of devices. As reusable surgical instruments categorized under Class A risk and notified under 29/Misc./03/2020-DC (193)- Part-3 dated 16.03.2022, these devices require proper regulatory approval to enter the Indian market. With over 25 years of experience helping 500+ companies navigate CDSCO licensing, we provide a detailed, practical roadmap for manufacturers and importers aiming to secure the MD5 manufacturing license for these instruments.
CDSCO Regulatory Framework for Insertion and Removal Instruments
In India, medical devices like insertion and removal instruments fall under the purview of the Central Drugs Standard Control Organization (CDSCO). Governed by the Medical Device Rules (MDR) 2017, these instruments are considered Class A devices due to their low risk profile. Licensing is mandatory for manufacturing and import to ensure safety, quality, and compliance with Essential Principles.
The regulatory framework involves:
- Device classification and risk assessment
- Test license acquisition
- Product testing at CDSCO-approved labs
- Submission of comprehensive documentation
- Inspection and audit by notified bodies
- Final grant of license
This structured process ensures devices meet Indian safety standards before market entry.
Risk Classification and License Requirements for Class A Devices
Insertion and removal instruments are classified as Class A devices, the lowest risk category under MDR 2017. This classification means the licensing authority is the State Licensing Authority, and the applicable manufacturing license is the MD5 license (Form MD3).
Key points for Class A devices:
- Licensing authority: State Licensing Authority
- License type: MD5 Manufacturing License
- Application forms: MD13 (Test License), MD3 (Manufacturing License)
- Total processing time: Approximately 3-4 months
- Testing and audit mandatory before license grant
For detailed classification criteria, refer to our Medical Device Classification guide.
Manufacturing License Process (MD5) for Insertion and Removal Instruments
The MD5 license process for Class A devices involves multiple stages:
- Test License Application (Form MD13): Initial step to legally manufacture and test products in India. Takes about 1.5-2 months for approval.
- Product Testing: Conducted at CDSCO-approved government labs. Testing ensures compliance with Indian standards. Check the list of testing laboratories for facility options.
- Documentation Preparation: Compilation of Device Master File, Plant Master File, Essential Principles Checklist, Risk Management File, test reports, labels, and QMS documentation.
- Manufacturing License Application (Form MD3): Submission on the CDSCO MD Online Portal after successful testing.
- Audit by Notified Body: An audit of manufacturing premises and quality systems by a notified body listed here.
- Query Resolution: Addressing any observations raised during audit or by the licensing authority.
- Grant of License (Form MD5): Final approval issued by the State Licensing Authority.
This structured approach ensures quality and regulatory compliance before market launch.
Manufacturing License Documents Required for Class A Insertion and Removal Instruments
Successful license application depends on comprehensive documentation, including:
- Company Constitution (Incorporation Certificate, MOA & AOA)
- 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 detailing device description, design, and specifications (Device Master File guide)
- Plant Master File describing manufacturing processes and facilities (Plant Master File guide)
- Essential Principles Compliance Checklist
- Risk Management File demonstrating hazard identification and mitigation (Risk Management guide)
- Test Reports from CDSCO-approved labs
- Product labels and Instructions for Use (IFU)
- Quality Management System (QMS) documentation, typically ISO 13485:2016 certification
Thorough preparation of these documents significantly smoothens the audit and approval process.
Import License Process (MD15) for Insertion and Removal Instruments
Although your device is Class A and primarily manufactured domestically, importers must obtain an MD15 license granted by the Central Licensing Authority. The process entails:
- Preparation of import documentation, including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016, and CE certificate if applicable
- Submission of Form MD14 via the CDSCO MD Online Portal
- Addressing queries from CDSCO
- License grant on Form MD15 within 5-6 months
Required documents include the manufacturing license, Free Sale Certificate, Device and Plant Master Files, Wholesale License, and Company Constitution.
For detailed guidance, see our Import License guide.
Import License Documents Required
- Valid foreign manufacturing license
- Free Sale Certificate from country of origin
- ISO 13485:2016 QMS certificate
- CE Certificate (if applicable)
- Device Master File and Plant Master File
- Wholesale license in India
- Company Constitution documents
Ensuring completeness of these documents expedites the approval process.
Timeline and Processing Duration
| Process Stage | Duration (Approximate) |
|---|---|
| Test License (MD13) | 1.5 - 2 months |
| Product Testing | 1 - 1.5 months |
| Manufacturing License (MD5) | 1 - 1.5 months |
| Total Processing Time | 3 - 4 months |
The timelines are indicative and depend on prompt responses to queries and audit readiness.
Government Fees and Costs
- MD5 License Application Fee: Rs. 5,000 per application
- Product Fee: Rs. 500 per product
Additional costs may include:
- Testing laboratory fees
- Notified body audit charges
- Documentation preparation and consultancy fees
Budgeting for these expenses upfront helps manufacturers avoid surprises.
Common Challenges and Practical Solutions
Challenge 1: Delays in product testing due to lab backlogs.
- Solution: Plan testing early and select less busy CDSCO-approved labs from the official list.
Challenge 2: Non-compliance in documentation leading to audit queries.
- Solution: Use detailed checklists for Device Master File and Plant Master File preparation; consider expert review.
Challenge 3: Audit readiness gaps in quality management systems.
- Solution: Implement ISO 13485:2016 compliant QMS and conduct internal audits before notified body inspection.
Challenge 4: Slow query resolution prolonging license grant.
- Solution: Assign experienced personnel to promptly address and respond to CDSCO notices.
Expert Consultation and Support
Navigating CDSCO licensing for insertion and removal instruments can be complex. Our team, with 25+ years of expertise and over 500 successful client approvals, offers:
- End-to-end application management
- Documentation preparation and gap analysis
- Liaison with CDSCO and notified bodies
- Internal audit and training for compliance
- Strategic planning for timely license grant
Partnering with experts ensures regulatory adherence and faster market access.
Getting Started with Your CDSCO License Application
To initiate your CDSCO MD5 license application for insertion and removal instruments, follow these practical next steps:
- Assess Your Device Classification: Confirm Class A status using official guidelines.
- Gather Required Documents: Start compiling company, technical, and product files.
- Apply for Test License (Form MD13): Submit via the CDSCO MD Online Portal.
- Plan Product Testing: Identify and coordinate with an approved testing laboratory early.
- Prepare for Audit: Align your manufacturing site and QMS with regulatory expectations.
- Submit Manufacturing License Application (Form MD3): After successful testing.
- Engage with Notified Body: Schedule and prepare for the audit.
By following this roadmap and leveraging expert guidance, you can efficiently secure your CDSCO MD5 license and bring your insertion and removal instruments to the Indian market with confidence.
For comprehensive assistance, explore our detailed resources and contact us to discuss your specific requirements.
