CDSCO License for Diaphragm pessary

Comprehensive Guide to CDSCO Licensing for Diaphragm Pessary (Class C Medical Device)

At our consultancy, with over 25 years of expertise and having supported more than 500 medical device companies, we understand the complexities manufacturers and importers face in securing CDSCO licenses. This guide focuses specifically on the Diaphragm pessary, a Class C obstetrical and gynecological device, providing you with actionable insights and detailed steps to obtain your CDSCO license efficiently.

Understanding the Diaphragm Pessary and Its Regulatory Importance

A diaphragm pessary is a circular vaginal device intended for mechanical contraception. Given its critical role in reproductive health, the device is classified as a Class C medical device under the Indian regulatory framework. This classification reflects a moderate to high risk, necessitating stringent regulatory oversight to ensure safety, efficacy, and quality.

Obtaining a CDSCO license is mandatory before manufacturing or importing this device in India. Compliance assures not only legal market entry but also builds trust among healthcare providers and end-users.

CDSCO Regulatory Framework for Class C Obstetrical and Gynecological Devices

The Central Drugs Standard Control Organization (CDSCO) governs the regulation of medical devices in India. For Class C devices like the diaphragm pessary, the licensing responsibility falls under the Central Licensing Authority.

The regulatory framework involves several stages: product testing, documentation, application submission, audits, and final license grant. The process ensures conformity with Indian standards and international best practices.

Risk Classification and License Requirements for Diaphragm Pessary

• Device: Diaphragm pessary
• Risk Class: C (Moderate to High Risk)
• Category: Obstetrical and Gynecological

Given the Class C classification, manufacturers must apply for an MD9 Manufacturing License (Form MD7), while importers seek the MD15 Import License.

For this article, we focus on the manufacturing license process.

Manufacturing License Process: MD9 License (Form MD7)

The MD9 license is mandatory for manufacturing Class C devices and is granted by the Central Licensing Authority. The typical process involves:

1. Test License (MD13): Before applying for the MD9 license, you must obtain a test license to conduct product testing. This process takes approximately 1.5 to 2 months.
2. Product Testing: Testing must be carried out at CDSCO-approved government laboratories. The test reports are critical for the subsequent license application.
3. Document Preparation: Prepare comprehensive documentation including Device Master File, Plant Master File, Risk Management File, and others.
4. Application Submission: Submit the MD9 application via the CDSCO MD Online Portal.
5. Audit: CDSCO inspectors conduct audits to verify compliance.
6. Query Resolution: Address any queries raised by CDSCO or auditors promptly.
7. License Grant: Upon satisfactory review, the MD9 license is granted.

You can find a detailed overview of the MD9 License process here.

Manufacturing License Documents Required for Diaphragm Pessary

Preparing the right documents is crucial. For the MD9 license, the following are required:

• Company Constitution: Certificate of incorporation, partnership deed, or equivalent
• Proof of Premises Ownership: Rent agreement or ownership deed
• Technical Staff Details: Qualifications and experience certificates of key personnel
• Fire and Pollution NOCs: Obtained from local authorities
• Device Master File (DMF): Detailed design, specifications, and manufacturing process documentation. Refer to our Device Master File guide
• Plant Master File (PMF): Description of the manufacturing facility, equipment, and quality systems. Learn how to create a PMF here
• Essential Principles Checklist: Compliance with CDSCO notified essential principles
• Risk Management File: Risk assessment and mitigation plans following ISO 14971 principles. Our risk management guide can help
• Test Reports: From CDSCO-approved labs
• Product Labels and Instructions for Use (IFU): Compliant with regulatory requirements
• Quality Management System (QMS) Documents: ISO 13485:2016 certification and related SOPs

Import License Process: MD15 License (Form MD14)

For importers wishing to bring the diaphragm pessary into India, the MD15 import license is required. The process includes:

• Document preparation (including manufacturing license from the exporting country)
• Submission on the CDSCO MD Online Portal
• Query resolution
• License grant

Typical timelines range from 5 to 6 months.

More detailed guidance is available in our Import License guide.

Timeline and Processing Duration

For manufacturers applying for the MD9 license of a diaphragm pessary:

• Test License (MD13): 1.5 to 2 months
• Product Testing: Approx. 2 to 3 weeks depending on lab backlog
• Document Preparation: Variable, typically 2 to 4 weeks
• Application Review and Audit: 1 to 2 months
• Query Resolution: 2 to 4 weeks
• Total Estimated Duration: 4 to 5 months

Government Fees and Costs

• MD9 License Fee: Rs. 50,000 per application
• Product Fee: Rs. 1,000 per product (per variant or model)
• Test License Fee (MD13): Included in application processing

Additional costs may include audit fees charged by notified bodies and laboratory testing fees. For a list of CDSCO-approved testing laboratories, refer to the official portal.

Common Challenges and Solutions

Challenge 1: Delays in Product Testing

• Solution: Engage early with approved labs, schedule testing slots ahead of application, and consider multiple labs to avoid bottlenecks.

Challenge 2: Incomplete or Non-Compliant Documentation

• Solution: Use checklists and templates, leverage expert consultants, and conduct internal audits prior to submission.

Challenge 3: Audit Non-Conformities

• Solution: Prepare thoroughly by understanding CDSCO audit criteria, maintain rigorous QMS, and ensure all records are up to date.

Challenge 4: Query Resolution Delays

• Solution: Respond promptly with clear, evidence-backed information. Establish a dedicated regulatory team or outsource to experts.

Expert Consultation and Support

Navigating CDSCO licensing for Class C devices like diaphragm pessaries requires nuanced understanding and practical experience. Our team has successfully guided 500+ companies through this journey, ensuring timely approvals and market access.

We offer tailored services including:

• Gap analysis and readiness assessments
• Document preparation and review
• Coordination with testing labs and notified bodies
• Audit preparation and training
• Application submission and follow-up

Connect with us early in your project lifecycle to streamline your regulatory pathway.

Getting Started with Your CDSCO License Application

1. Evaluate Device Classification: Confirm that your diaphragm pessary falls under Class C per the Medical Device Classification guidelines.
2. Prepare Technical Documentation: Begin drafting your Device and Plant Master Files alongside risk management and QMS documents.
3. Apply for Test License (MD13): Submit the test license application via the CDSCO MD Online Portal.
4. Schedule Product Testing: Coordinate with CDSCO-approved laboratories promptly.
5. Compile Complete Application: Assemble all documents as per MD9 requirements.
6. Submit Application for MD9 License: Use the online portal ensuring correct forms (MD7) and fees.
7. Prepare for Audit: Engage with notified bodies and audit teams; consider reviewing the list of notified bodies authorized for Class C audits.
8. Respond to Queries Quickly: Maintain communication channels open with CDSCO officers.

By following these concrete steps and leveraging expert support, your diaphragm pessary manufacturing license application can proceed efficiently, enabling successful entry into the Indian market.

For personalized assistance or to discuss your specific project, reach out to our regulatory consultancy team.

Note: This content is regularly updated to reflect the latest regulatory guidelines and market practices as per CDSCO notifications, including File No. 29/Misc./03/2020-DC (181) dated 03.06.2022.