CDSCO License for Manual expandable cervical dilator

Comprehensive Guide to CDSCO Licensing for Manual Expandable Cervical Dilator (Class B Medical Device)

Manufacturers and importers aiming to market the Manual Expandable Cervical Dilator in India must navigate the Central Drugs Standard Control Organization (CDSCO) regulatory framework effectively. This device, classified as a Class B medical device under the obstetrical and gynecological category, plays a critical role in dilating the cervical canal using a balloon when uterine inertia limits natural dilation. Understanding the regulatory pathway, timelines, costs, and documentation is essential for a smooth entry into the Indian healthcare market.

CDSCO Regulatory Framework for Manual Expandable Cervical Dilator

As per the CDSCO notification (File No. 29/Misc./03/2020-DC (181), dated 03.06.2022), the Manual Expandable Cervical Dilator falls under Class B risk classification. Such devices require a manufacturing license (MD5) issued by the State Licensing Authority. This regulatory control ensures safety, performance, and quality compliance before the device reaches patients.

Risk Classification and License Requirements for Class B Devices

Class B devices, including the Manual Expandable Cervical Dilator, are categorized as low to moderate risk. The CDSCO mandates a comprehensive process involving a test license (MD13), product testing, an audit by a notified body, and submission of detailed technical documentation prior to granting the MD5 license.

You can find an overview of risk classification on our Medical Device Classification page.

Manufacturing License Process (MD5) for Manual Expandable Cervical Dilator

The MD5 manufacturing license process encompasses several critical phases:

1. Test License (Form MD13): Initiate by applying for a test license on the CDSCO MD Online Portal. This license allows for product testing and documentation preparation, typically taking 1.5 to 2 months.

2. Product Testing: Mandatory testing must be conducted at CDSCO-approved laboratories. Refer to the Testing Laboratories list to select certified labs.

3. Document Preparation: Compile essential documents including Device Master File, Plant Master File, Risk Management File, and Essential Principles Checklist.

4. Application Submission (Form MD3): Submit the MD5 license application via the CDSCO MD Online Portal.

5. Audit by Notified Body: An audit conducted by a notified body evaluates compliance with Good Manufacturing Practices (GMP). You can check the Notified Bodies List to appoint an authorized auditor.

6. Queries Resolution: Address any clarifications or observations raised by the licensing authority or notified body promptly.

7. License Grant (Form MD5): Upon successful completion, the State Licensing Authority grants the MD5 manufacturing license.

For an in-depth understanding, our MD5 License Guide provides step-by-step instructions.

Manufacturing License Documents Required

The documentation package for the Manual Expandable Cervical Dilator must be thorough and precise, including:

• Company Constitution and Incorporation Certificate: Proves the legal entity.
• Proof of Premises Ownership or Lease Agreement: Validates manufacturing location.
• Technical Staff Credentials: Qualifications and experience certificates of key personnel.
• Fire and Pollution No Objection Certificates (NOCs): Compliance with safety and environmental regulations.
• Device Master File (DMF): Detailed device specifications, design, manufacturing process, and quality controls. Our Device Master File Guide can help streamline this.
• Plant Master File (PMF): Description of manufacturing facility, equipment, and quality control systems. Learn to prepare a PMF through our Plant Master File Guide.
• Essential Principles Checklist: Confirming compliance with Indian regulatory requirements.
• Risk Management File: Risk analysis and mitigation strategies tailored to the cervical dilator.
• Test Reports: From CDSCO-approved labs validating performance and safety.
• Product Labels and Instructions for Use (IFU): Clear, compliant labeling is critical.
• Quality Management System (QMS) Documentation: ISO 13485:2016 certification and internal procedures.

Import License Process (MD15) for Manual Expandable Cervical Dilator

If you intend to import the device, an Import License (MD15) is mandatory. This license is granted by the Central Licensing Authority and does not require a test license. The process includes:

• Document preparation including manufacturing license, Free Sale Certificate, ISO 13485, and CE Certificate.
• Submission of application on the CDSCO MD Online Portal using Form MD14.
• Queries resolution.
• License grant on Form MD15.

Our Import License Guide offers detailed insights.

Import License Documents Required

• Valid Manufacturing License from country of origin
• Free Sale Certificate
• ISO 13485:2016 certification
• CE Certificate or equivalent
• Device Master File
• Plant Master File
• Wholesale License
• Company Constitution

Timeline and Processing Duration

For Class B devices such as the Manual Expandable Cervical Dilator, the entire MD5 license process typically takes 3 to 4 months. Breakdown:

• Test License (MD13): 1.5 to 2 months
• Product Testing: 3 to 6 weeks
• Application processing, audit, and queries resolution: 4 to 6 weeks

Import license (MD15) processing takes around 5 to 6 months due to the centralized authority and comprehensive document verification.

Government Fees and Costs

• MD5 License Fee: Rs. 5,000 per application + Rs. 500 per product
• Test License Fee (MD13): Included in overall process costs
• Audit Fees: Payable to notified bodies, varies by auditor

Budgeting for professional consultancy to assist in documentation and audit preparation is advisable to avoid delays.

Common Challenges and Solutions

• Incomplete Documentation: Ensure all files, especially Device and Plant Master Files, are comprehensive and up to date. Engage experts early.
• Delayed Testing Results: Select CDSCO-approved laboratories with proven turnaround times.
• Audit Non-Compliance: Conduct internal audits before notified body visits to identify gaps.
• Query Resolution Delays: Maintain clear communication and promptly address all regulator queries.

Expert Consultation and Support

With over 25 years of experience assisting 500+ companies, we specialize in CDSCO licensing for obstetrical and gynecological devices. Our tailored support includes document preparation, audit readiness, testing coordination, and regulatory strategy, ensuring your Manual Expandable Cervical Dilator reaches the Indian market efficiently.

Getting Started with Your CDSCO License Application

1. Evaluate your Device Classification: Confirm Class B status and understand license type.
2. Prepare Documentation: Gather company, technical, and quality documents.
3. Apply for Test License (MD13): Submit via the CDSCO MD Online Portal.
4. Coordinate Product Testing: Select approved labs and schedule testing.
5. Engage a Notified Body: Arrange for GMP audit early.
6. Submit MD5 License Application: Complete Form MD3 with comprehensive documentation.
7. Respond to Queries: Maintain prompt communication with CDSCO.

Taking these practical steps with expert guidance minimizes delays and maximizes approval success for your Manual Expandable Cervical Dilator. For personalized assistance and compliance assurance, reach out to our regulatory consultancy team today.