CDSCO License for Medication Injector
Medical Device Information
Intended Use
A subcutaneous injection is a method of administering medication.
Comprehensive Guide to CDSCO Licensing for Medication Injectors (Class B Medical Device)
Medication injectors, such as disposable hypodermic needles used for subcutaneous administration of medication, are critical medical devices ensuring safe and effective drug delivery. Given their direct patient contact, these devices fall under the Class B risk category in India’s regulatory framework, demanding stringent compliance with the Central Drugs Standard Control Organization (CDSCO) regulations.
With over 25 years of experience and successful facilitation of CDSCO licensing for 500+ medical device companies, we understand the nuances manufacturers and importers face. This guide provides an in-depth, actionable roadmap for securing your CDSCO manufacturing or import license for Medication Injectors, referencing the official notification 29/Misc/3/2017-DC (292) dated 06.06.2018.
CDSCO Regulatory Framework for Medication Injectors
The CDSCO governs medical devices under the Medical Device Rules (MDR) 2017. Medication Injectors, categorized under disposable hypodermic needles, require adherence to quality, safety, and performance standards before entering the Indian market. Compliance ensures patient safety and legal market access.
The device falls under:
- Risk Class: B (Low-to-moderate risk)
- Category: Disposable Hypodermic Needles
- Notification: 29/Misc/3/2017-DC (292) dated 06.06.2018
Understanding this classification is critical for determining the appropriate licensing pathway.
Risk Classification and License Requirements for Medication Injectors
Class B devices like Medication Injectors require an MD5 manufacturing license issued by the State Licensing Authority. This license confirms that the manufacturing setup complies with regulatory requirements.
Key points:
- License Type: MD5 License
- Application Form: MD3
- Issued By: State Licensing Authority
- Total timeline: Approximately 3-4 months
- Fees: Rs 5,000 (application) + Rs 500 per product
Manufacturers must first secure a Test License (Form MD13) before applying for MD5.
For importers, separate import licenses (Form MD15) are applicable under the CDSCO Central Licensing Authority.
Manufacturing License Process for Medication Injectors (MD5 License)
Step 1: Obtain Test License (Form MD13)
Before applying for the MD5 license, manufacturers must apply for a Test License allowing them to produce samples for testing. This process takes around 1.5 to 2 months.
Step 2: Product Testing
Samples must be tested at CDSCO-approved laboratories. You can refer to the list of testing laboratories recognized by CDSCO. Test reports are essential for license application.
Step 3: Documentation Preparation
Prepare a comprehensive dossier including Device Master File, Plant Master File, Risk Management File, and Essential Principles Checklist.
Step 4: Submit MD5 Application (Form MD3)
Submit your application through the CDSCO MD Online Portal. Ensure all documents are complete to avoid delays.
Step 5: Audit by Notified Body
A notified body, listed here, will conduct an audit of your manufacturing facility and QMS.
Step 6: Address Queries and Grant of License
Respond promptly to any queries raised by CDSCO or the notified body. Upon satisfactory resolution, the MD5 license will be granted.
Manufacturing License Documents Required for Medication Injectors
Your application must include the following:
- Company Constitution (Incorporation Certificate, Memorandum & Articles of Association)
- Proof of Ownership or Lease of Manufacturing Premises
- Details and Qualifications of Technical Staff
- Fire and Pollution NOCs
- Device Master File (Refer to our detailed Device Master File guide)
- Plant Master File (Plant Master File Guide)
- Essential Principles Checklist
- Risk Management File (per ISO 14971 standards; see Risk Management tips)
- Product Test Reports from CDSCO-approved labs
- Labels and Instructions for Use (IFU)
- Quality Management System Documents (ISO 13485:2016 certification is advantageous)
Import License Process for Medication Injectors (MD15 License)
Importers must apply for an MD15 license through the Central Licensing Authority. The process typically takes 5-6 months.
Key Steps:
- Document Preparation: Manufacturing License from country of origin, Free Sale Certificate, ISO 13485:2016, CE Certificate, Device and Plant Master Files, Wholesale License, Company Constitution
- Application Submission: Use Form MD14 on the CDSCO MD Online Portal
- Queries Resolution: Timely response to CDSCO queries
- License Grant: Issuance of MD15 License
Import License Documents Required
- Valid Manufacturing License from the country of origin
- Free Sale Certificate
- ISO 13485:2016 Certificate
- CE Marking Certificate (if applicable)
- Device Master File
- Plant Master File
- Wholesale License (if applicable)
- Company Constitution documents
Timeline and Processing Duration
| License Type | Steps Involved | Approximate Duration |
|---|---|---|
| Test License (MD13) | Application, Testing | 1.5 - 2 months |
| MD5 License | Document prep, audit, queries, grant | 3 - 4 months total |
| MD15 Import License | Document prep, queries, grant | 5 - 6 months |
Starting early and maintaining clear communication with CDSCO expedites approvals.
Government Fees and Costs
| License Type | Application Fee | Per Product Fee | Notes |
|---|---|---|---|
| MD5 | Rs 5,000 | Rs 500 | State Authority |
Additional costs include testing fees at government-approved laboratories and notified body audit charges.
Common Challenges and Solutions
- Incomplete Documentation: Always cross-check your dossier against CDSCO checklists and ensure Device and Plant Master Files are up-to-date.
- Delayed Testing: Schedule testing in advance with CDSCO-approved labs to avoid bottlenecks.
- Audit Non-compliance: Pre-audit your manufacturing facility and QMS with expert consultants to identify gaps.
- Query Resolution Delays: Assign dedicated regulatory personnel to address CDSCO queries promptly.
Practical Tip: Leverage our expertise to conduct mock audits and dossier reviews, significantly reducing the risk of rejection or delays.
Expert Consultation and Support
Navigating CDSCO licensing is complex, especially for Class B devices like Medication Injectors. Our 25+ years in regulatory consulting have empowered over 500 companies to achieve timely approvals.
We offer:
- End-to-end application preparation
- Device Master File and Plant Master File creation
- Coordination with notified bodies and testing labs
- Post-license compliance support
Connect with our experts early to streamline your licensing journey.
Getting Started with Your CDSCO License Application
- Assess Your Device Classification: Confirm your device is Class B using resources like our Medical Device Classification guide.
- Prepare Test License Application: Gather all required documents and submit Form MD13 via the CDSCO MD Online Portal.
- Plan for Testing: Coordinate with CDSCO-approved labs for timely product testing.
- Compile Licensing Dossier: Develop comprehensive Device and Plant Master Files, risk management documentation, and QMS manuals.
- Schedule Notified Body Audit: Select an appropriate notified body from the official list and prepare for inspection.
- Submit MD5 Application: File Form MD3 on the CDSCO portal with all supporting documents.
- Respond to Queries Promptly: Maintain proactive communication with CDSCO to resolve any concerns.
Taking these practical steps with expert guidance ensures a smooth pathway to obtaining your CDSCO license for Medication Injectors, facilitating safe market entry in India.
For personalized assistance and to discuss your specific requirements, contact our regulatory experts today and leverage our proven track record in CDSCO licensing success.
