CDSCO License for Uterine injector

Comprehensive Guide to CDSCO Licensing for Uterine Injector (Class B Medical Device)

Navigating the regulatory landscape for medical devices in India can be complex, especially for specialized devices like the uterine injector. As a reusable obstetrical and gynecological device classified as Class B under CDSCO regulations, obtaining the correct license is critical for legal manufacturing and distribution within India. With over 25 years of experience assisting 500+ companies, we provide detailed, actionable guidance to streamline your licensing process.

Understanding the Uterine Injector and Its Regulatory Importance

The uterine injector is designed to inject liquids, drugs, or other substances directly into the uterus. Given its invasive nature and repeated use, regulatory oversight ensures the device meets safety, performance, and quality standards to protect patients and healthcare providers. India’s Central Drugs Standard Control Organization (CDSCO) mandates compliance with its medical device regulations, requiring manufacturers to obtain the appropriate licenses before market entry.

CDSCO Regulatory Framework for Uterine Injectors

Under the Medical Device Rules (MDR) 2017, uterine injectors fall under Class B risk category due to moderate risk associated with their use. The regulatory framework demands adherence to:

• Quality Management Systems (QMS) aligned with ISO 13485:2016
• Pre-market testing in government-approved laboratories
• Device Master File (DMF) and Plant Master File (PMF) documentation
• Compliance with essential principles of safety and performance

The relevant license for manufacturing this device is the MD5 license, issued by the State Licensing Authority.

Risk Classification and License Requirements for Uterine Injector

Class B devices like the uterine injector require an MD5 license (Form MD3 application). This is a state-level manufacturing license involving:

• Test license acquisition (Form MD13)
• Product testing in CDSCO-approved labs
• Notified body audit
• Submission of comprehensive technical and administrative documentation

The MD5 license process typically spans 3-4 months when managed efficiently.

Manufacturing License Process (MD5) for Uterine Injector

1. Apply for Test License (MD13): Mandatory preliminary step to legally test the uterine injector. This takes approximately 1.5 to 2 months.
2. Product Testing: Conducted in government-approved labs to validate safety and performance. Testing duration varies by lab but averages 4-6 weeks.
3. Document Preparation: Assemble required documents including Device Master File, Plant Master File, Risk Management File, and QMS documents.
4. Submit MD5 Application (MD3 Form): File your manufacturing license application through the CDSCO MD Online Portal.
5. Audit by Notified Body: Select a notified body from the official list for compliance audit.
6. Query Resolution: Address any queries or deficiencies raised by CDSCO or the notified body promptly.
7. License Grant: Upon satisfactory review and audit, the MD5 license is granted.

Manufacturing License Documents Required for Uterine Injector

• Company Constitution and Incorporation Certificates
• Proof of Ownership or Lease of Manufacturing Premises
• Technical Staff Qualifications and Experience
• Fire No Objection Certificate (NOC)
• Pollution Control Board Clearance
• Device Master File (Detailed design, specifications, and manufacturing process) Learn more
• Plant Master File (Manufacturing facilities and quality systems) Guide here
• Essential Principles Checklist
• Risk Management File (Risk analysis and mitigation strategies) Insights here
• Test Reports from CDSCO-approved laboratories Lab list
• Product Labels and Instructions for Use (IFU)
• Quality Management System (QMS) Documents (ISO 13485 compliance proofs)

Import License Process (MD15) for Uterine Injector

For importers, the MD15 license issued by the Central Licensing Authority is mandatory. Given the uterine injector is a Class B device, the process includes:

• Preparation of comprehensive technical and quality documentation
• Submission of application on the CDSCO MD Online Portal
• Resolution of any departmental queries
• License issuance typically within 5-6 months

Note: Test license is not required for import licensing.

Import License Documents Required

• Valid Manufacturing License from the country of origin
• Free Sale Certificate from the country of origin
• ISO 13485:2016 Certification
• CE Certificate (if applicable)
• Device Master File and Plant Master File
• Wholesale License
• Company Constitution and Incorporation Documents

Timeline and Processing Duration

For import licensing (MD15), expect around 5-6 months total processing time.

Government Fees and Costs

• MD5 Manufacturing License: Rs 5,000 per application + Rs 500 per product
• Test License (MD13): Included in application process costs
• Notified Body Audit Fees: Varies depending on the notified body chosen

These fees are applicable as per the latest CDSCO guidelines and payable via the MD Online Portal.

Common Challenges and Practical Solutions

• Document Completeness: Incomplete or improperly formatted documents cause delays. Use detailed checklists and expert reviews.
• Lab Testing Delays: Book slots early with CDSCO-approved labs and confirm test protocols.
• Audit Readiness: Prepare thoroughly for notified body audits with mock audits and training.
• Query Management: Assign dedicated regulatory personnel to address queries swiftly.

Expert Consultation and Support

With 25+ years and 500+ successful CDSCO license approvals, our consultancy provides end-to-end support, including:

• Device classification and regulatory strategy
• Documentation preparation and review
• Coordination with testing labs and notified bodies
• Training for audit and compliance readiness
• Application submission and follow-up

Our expertise minimizes your risk of delays and non-compliance.

Getting Started with Your CDSCO License Application for Uterine Injector

1. Verify Device Classification: Confirm Class B status and regulatory pathway.
2. Gather Required Documents: Start assembling your Device Master File, Plant Master File, and technical documentation.
3. Apply for Test License (Form MD13): Submit through the CDSCO MD Online Portal to initiate product testing.
4. Select a Notified Body: Choose from the approved list for your audit.
5. Plan Testing and Audit Timelines: Coordinate lab testing and audit schedules to optimize process flow.
6. Prepare for Submission: Ensure all documentation complies with CDSCO guidelines before applying for the MD5 license.

By following these steps and leveraging expert guidance, manufacturers of uterine injectors can successfully enter the Indian market with confidence and compliance.