CDSCO License for Uterine packer

Comprehensive CDSCO Licensing Guide for Uterine Packer (Class A Medical Device)

As a hand-held, reusable surgical instrument designed for introducing dressings into the uterus or vagina, the uterine packer falls under the obstetrical and gynecological category and is classified as a Class A medical device according to the CDSCO framework. With over 25 years of experience and having supported more than 500 companies in successfully navigating CDSCO licensing, we provide you with an in-depth, practical roadmap to help you obtain the necessary approvals and enter the Indian market efficiently.

Understanding the CDSCO Regulatory Framework for Uterine Packers

The Central Drugs Standard Control Organization (CDSCO) regulates all medical devices in India. Since the uterine packer is a Class A device — representing low risk — the licensing process is managed by the State Licensing Authority via the MD5 manufacturing license application (Form MD3). The regulatory framework ensures the device’s safety, efficacy, and quality before it reaches healthcare providers.

Risk Classification and License Requirements for Uterine Packers

Class A devices like the uterine packer require an MD5 manufacturing license, which involves a test license, product testing, documentation, and audit. Here’s a quick overview:

• Risk Class: Class A (low risk)
• License Type: MD5 Manufacturing License (Form MD3)
• Issuing Authority: State Licensing Authority
• Process Duration: Approximately 3-4 months

For detailed classification, manufacturers can refer to this Medical Device Classification guide.

Step-by-Step Manufacturing License Process for Uterine Packers (MD5 License)

1. Obtain Test License (Form MD13): Before manufacturing, apply for a test license to produce limited quantities for product testing. This step takes about 1.5-2 months.
2. Product Testing: Submit your uterine packer samples to government-approved testing laboratories to demonstrate compliance with applicable standards. The list of approved testing laboratories is available on the CDSCO portal.
3. Document Preparation: Prepare comprehensive documentation, including the Device Master File (DMF), Plant Master File (PMF), Essential Principles Checklist, Risk Management File, and Quality Management System (QMS) documents.
4. Apply for MD5 License (Form MD3): Submit your complete application through the CDSCO MD Online Portal.
5. Audit by Notified Body: Coordinate with a notified body for the required audit of your manufacturing facility and processes. Refer to the list of notified bodies authorized for MD5 audits.
6. Respond to Queries: Address any observations or queries raised during the audit or by the licensing authority.
7. Grant of License: Upon successful evaluation, the State Licensing Authority issues the MD5 license (Form MD5).

For a detailed walkthrough, see our MD5 License Guide.

Essential Documents Required for Uterine Packer Manufacturing License

To streamline your application, ensure you have the following key documents ready:

• Company Constitution (Memorandum and Articles of Association)
• Proof of Ownership or Lease of Manufacturing Premises
• Details and Qualifications of Technical Staff
• Fire NOC and Pollution Control Board NOC
• Device Master File (DMF) — covering design, specifications, manufacturing process. Learn how to prepare a DMF here: Device Master File Guide
• Plant Master File (PMF) — detailing manufacturing infrastructure and quality systems. See our Plant Master File Guide
• Essential Principles Checklist (demonstrating compliance with safety and performance requirements)
• Risk Management File (including risk analysis and mitigation strategies) — guidance available at Risk Management
• Test Reports from CDSCO-approved laboratories
• Product Labels and Instructions for Use (IFU)
• Quality Management System (QMS) Documentation (ISO 13485:2016 preferred)

Import License Process for Uterine Packers (If Applicable)

If you intend to import uterine packers instead of manufacturing domestically, you will need to apply for the MD15 import license through the Central Licensing Authority. This process typically takes 5-6 months and requires:

• 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 and Plant Master File
• Wholesale License
• Company Constitution

The application is submitted via the CDSCO MD Online Portal, and fees vary depending on device class. For more, visit our Import License Guide.

Timeline and Processing Duration

For uterine packers as Class A devices, expect the following timeline:

• Test License (MD13): 1.5 to 2 months
• Product Testing: 3-4 weeks (depending on lab workload)
• Document Preparation: Concurrent with testing
• MD5 License Application & Audit: 1.5 to 2 months

Total estimated duration: 3 to 4 months from test license application to license grant.

Government Fees and Cost Breakdown

• Test License (MD13) fees: Nominal, often included within application processing
• MD5 Manufacturing License Fees:
  • Rs 5,000 per application
  • Rs 500 per product

Additional costs include testing laboratory fees (varies by test complexity), audit fees charged by notified bodies, and professional consultancy if engaged.

Common Challenges and Practical Solutions

• Delays in Product Testing: Government labs can have backlogs. To mitigate, submit samples early and consider parallel document preparation.
• Incomplete Documentation: Missing or poorly prepared DMF, PMF, or Risk Management Files often trigger queries. Engage expert consultants early to ensure compliance.
• Audit Non-Compliance: Failing audits due to inadequate QMS or facility readiness is common. Conduct pre-audit internal reviews and training.
• Query Resolution Delays: Promptly and comprehensively respond to authority queries to avoid process stalls.

Expert Consultation and Support

Navigating CDSCO licensing can be complex, especially for reusable surgical instruments like uterine packers. With our 25+ years of regulatory consulting and over 500 successful client cases, we offer:

• End-to-end license application support
• Documentation preparation and review
• Coordination with notified bodies and testing labs
• Query management with CDSCO authorities

Our expertise ensures smoother, faster approvals and compliance.

Getting Started with Your CDSCO License Application

1. Confirm classification: Verify your uterine packer’s Class A status using official CDSCO resources.
2. Prepare your documentation: Start compiling DMF, PMF, risk management, and QMS files.
3. Apply for the test license (Form MD13): Submit your application via the CDSCO MD Online Portal to initiate manufacturing for testing.
4. Plan product testing: Coordinate sample submission to government-approved laboratories.
5. Schedule the audit: Identify and engage with a notified body early to arrange the manufacturing site audit.
6. Submit MD5 license application: Once testing and audit are complete, apply via the portal with all supporting documents.

By following these precise steps, you can confidently navigate the licensing process for your uterine packer and successfully enter the Indian medical device market.

For further detailed assistance, feel free to consult our MD5 License Guide.

Our team remains committed to providing personalized, expert guidance tailored to your uterine packer manufacturing or import licensing needs. Contact us today to accelerate your CDSCO approval journey.