CDSCO License for Umbilical ligator

Comprehensive Guide to CDSCO Licensing for Umbilical Ligator (Class A Medical Device)

Manufacturing or importing a medical device like the umbilical ligator—a Class A surgical instrument used for umbilical cord ligation in obstetrical and gynecological settings—requires strict compliance with the Central Drugs Standard Control Organisation (CDSCO) regulations. With over 25 years of experience assisting 500+ companies, we understand the nuances involved in navigating the CDSCO licensing process efficiently.

The umbilical ligator, categorized under Class A (low risk), was notified under File No. 29/Misc./03/2020-DC (181) dated 03.6.2022, making it mandatory for manufacturers and importers to obtain the appropriate license before marketing in India.

CDSCO Regulatory Framework for Umbilical Ligator

The CDSCO regulates medical devices in India as per the Medical Device Rules (MDR) 2017. For Class A devices like the umbilical ligator, the licensing authority lies at the state level. Compliance includes obtaining a manufacturing license (MD5) or import license (MD15) depending on your business operation. The process emphasizes product quality, safety, and adherence to Essential Principles.

Risk Classification and License Requirements

According to the CDSCO classification, the umbilical ligator falls under Class A (low risk) devices. This classification mandates the following:

• Manufacturing License: MD5 License (Form MD3) issued by the State Licensing Authority.
• Import License: MD15 License (Form MD14) issued by the Central Licensing Authority.

Manufacturers must first obtain a test license (MD13) for product testing before applying for the MD5 license. Importers apply directly for the MD15 license.

Manufacturing License Process for Umbilical Ligator (MD5)

1. Apply for Test License (Form MD13): This initial step enables product testing in government-approved laboratories.
2. Product Testing: The umbilical ligator samples are tested for compliance with Indian standards by notified labs.
3. Document Preparation: Prepare comprehensive documents including Device Master File, Plant Master File, Quality Management System (QMS), and Risk Management File.
4. Submit Application (Form MD3): Apply for the MD5 manufacturing license via the CDSCO MD Online Portal.
5. Audit by Notified Body: A notified body listed here will audit manufacturing facilities and documentation.
6. Queries and Clarifications: Address any queries raised by the licensing authority or notified body promptly.
7. License Grant: Upon successful evaluation, the MD5 license is granted.

Manufacturing License Documents Required

• Company Constitution/Registration Certificate
• Proof of Ownership or Lease of Manufacturing Premises
• Details of Technical Staff (Qualifications and Experience)
• Fire and Pollution NOCs
• Device Master File (DMF) – detailed device description, design, and manufacturing process (Guide to DMF)
• Plant Master File (PMF) – manufacturing environment and quality control (PMF Guide)
• Essential Principles Compliance Checklist
• Risk Management File (Risk Management Guide)
• Product Test Reports from approved labs (Testing Labs List)
• Product Labels and Instructions for Use (IFU)
• Quality Management System Documents (ISO 13485:2016 recommended)

Import License Process for Umbilical Ligator (MD15)

For importers of the umbilical ligator, the process involves:

1. Document Preparation: Compile required licenses, certifications, and technical files.
2. Submit Application (Form MD14) for MD15 License: Apply via the CDSCO MD Online Portal.
3. Review and Queries: Respond to any departmental queries.
4. License Grant: Upon satisfactory review, the import license is issued.

Import License Documents Required

• Valid Manufacturing License from the country of origin
• Free Sale Certificate
• ISO 13485:2016 Certification
• CE Certificate or equivalent
• Device Master File and Plant Master File
• Wholesale License in India
• Company Constitution and Registration

Timeline and Processing Duration

• MD5 Manufacturing License: Approximately 3 to 4 months total.

  • Test License (MD13): 1.5 to 2 months
  • Product Testing: 3 to 4 weeks
  • Document submission and audit: 4 to 6 weeks
  • Query resolution and license grant: 2 to 3 weeks

• MD15 Import License: Approximately 5 to 6 months.

Government Fees and Costs

• MD5 License Fees: Rs. 5,000 per application + Rs. 500 per product.
• Test License (MD13): Separate fees as per state authority.

For the umbilical ligator, as a single Class A device, expect total fees around Rs. 5,500 for manufacturing license applications.

Common Challenges and Solutions

• Incomplete Documentation: Ensure all required files such as Device Master File and Risk Management File are meticulously prepared. Leverage our detailed templates and guides to avoid delays.
• Audit Non-Compliance: Prepare for notified body audits by conducting internal mock audits. Verify QMS and manufacturing processes are robust.
• Delayed Product Testing: Submit samples early to government-approved labs and maintain regular follow-ups.
• Query Resolution Delays: Assign a dedicated regulatory expert to respond to CDSCO queries promptly.

Expert Consultation and Support

With our extensive experience helping over 500 companies secure CDSCO licenses, we offer end-to-end support including document preparation, audit readiness, and application submission. Our team stays updated on regulatory changes ensuring your compliance strategy is future-proof.

Getting Started with Your CDSCO License Application

1. Assess Your Device Classification: Confirm the umbilical ligator is Class A via the CDSCO classification system (Medical Device Classification).
2. Prepare Comprehensive Documentation: Begin with creating Device and Plant Master Files using our expert guides.
3. Apply for Test License (MD13): Initiate product testing early by submitting your application on the CDSCO MD Online Portal.
4. Plan for Audit: Schedule pre-audit checks with a notified body from the official list.
5. Submit MD5 Application: Once test reports are available, complete your application for manufacturing license.

Starting early and maintaining clear communication with CDSCO and notified bodies significantly improves your chances of timely approval. Contact us today to leverage our expertise and fast-track your umbilical ligator’s entry into the Indian market.