CDSCO License for Pelvimeter

Introduction to Pelvimeter and Its Regulatory Importance

A Pelvimeter is a specialized obstetrical and gynecological measuring device designed to determine pelvic dimensions accurately. Given its critical role in prenatal care and childbirth planning, regulatory compliance is paramount to ensure patient safety and product efficacy. In India, the Central Drugs Standard Control Organization (CDSCO) oversees the robust licensing framework for medical devices like the Pelvimeter. Navigating this regulatory landscape effectively enables manufacturers and importers to access the growing Indian healthcare market while maintaining compliance with national safety standards.

CDSCO Regulatory Framework for Pelvimeter (Class B Medical Device)

Under the Medical Device Rules, 2017, the Pelvimeter falls under Class B (low-moderate risk). This classification mandates adherence to specific licensing protocols under CDSCO, including obtaining a manufacturing license (MD5) for domestic production or an import license (MD15) for imported devices. The notified file number 29/Misc./03/2020-DC (181) dated 03.06.2022 officially recognizes the Pelvimeter within this regulatory framework.

Risk Classification and License Requirements for Pelvimeter

Class B devices such as the Pelvimeter require a manufacturing license issued by the State Licensing Authority in the form of an MD5 license (Application Form MD3). For importers, the central authority issues an MD15 license. The classification influences the depth of documentation, testing, and audits necessary prior to license approval.

Manufacturing License Process (MD5) for Pelvimeter

Obtaining an MD5 license for your Pelvimeter manufacturing involves a well-defined multi-step process:

1. Test License Application (Form MD13): Apply for a test license to manufacture the device on a trial basis. This phase typically takes 1.5 to 2 months and is mandatory to validate the product's compliance.

2. Product Testing: Conduct testing at one of the government-approved laboratories listed on the CDSCO Testing Laboratories portal to verify safety and performance.

3. Document Preparation: Compile all required documentation including Device Master File, Plant Master File, Risk Management File, and Essential Principles Checklist.

4. Application Submission (Form MD3): Submit the manufacturing license application through the CDSCO MD Online Portal along with required fees.

5. Audit by Notified Body: Undergo an audit conducted by a notified body from the CDSCO Notified Bodies List to confirm compliance with Good Manufacturing Practices (GMP).

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

7. Grant of License (Form MD5): Upon successful review, the MD5 license is granted, permitting commercial manufacturing.

The entire process spans approximately 3 to 4 months.

Manufacturing License Documents Required for Pelvimeter

To facilitate a smooth application, ensure you have the following documents ready:

• Company Constitution (Registration Certificate)
• Proof of Ownership or Lease of Manufacturing Premises
• Qualification and Experience Documents of Technical Staff
• Fire No Objection Certificate (NOC)
• Pollution Control Board NOC
• Device Master File (DMF): Detailed specifications and manufacturing processes (Device Master File Guide)
• Plant Master File (PMF): Overview of manufacturing facilities and quality systems (Plant Master File Guide)
• Essential Principles Checklist
• Risk Management File adhering to ISO 14971 standards (Risk Management Guide)
• Test Reports from government-approved labs
• Labels and Instructions for Use (IFU)
• Quality Management System (QMS) Documents (ISO 13485:2016 compliance)

Import License Process (MD15) for Pelvimeter

For companies importing Pelvimeters into India, the MD15 license is mandatory and issued by the Central Licensing Authority. The process includes:

1. Document Preparation: Gather comprehensive documentation including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016, CE Certificate, along with Device and Plant Master Files.

2. Application Submission (Form MD14): Submit your application on the CDSCO MD Online Portal.

3. Queries and Clarifications: Respond promptly to any departmental queries.

4. Final License Grant (Form MD15): Upon satisfactory review, the import license is granted.

This process usually takes 5 to 6 months due to the central authority’s involvement and detailed document review.

Import License Documents Required for Pelvimeter

• Manufacturing License from Country of Origin
• Free Sale Certificate
• ISO 13485:2016 Certificate
• CE Certificate or equivalent
• Device Master File
• Plant Master File
• Wholesale License in India
• Company Constitution Document

Timeline and Processing Duration

Being proactive in document readiness and prompt query resolution can significantly reduce processing delays.

Government Fees and Costs for Pelvimeter Licensing

For a Class B device like the Pelvimeter, the fee structure is as follows:

• MD5 License: Rs. 5,000 per application + Rs. 500 per product
• MD15 Import License: $2,000 per site +$1,000 per product

Investing in thorough documentation and quality systems upfront can prevent costly rejections or audits.

Common Challenges and Solutions in CDSCO Licensing

• Incomplete Documentation: Many applicants face delays due to missing or inconsistent documents. Solution: Use detailed checklists and expert reviews before submission.

• Test Report Delays: Government-approved labs often have backlogs. Solution: Plan testing early and consider alternate notified labs listed on the CDSCO Testing Laboratories page.

• Audit Non-compliance: Failure to meet GMP standards during audits is common. Solution: Conduct internal audits and staff training prior to notified body visits.

• Query Resolution Delays: Slow responses to CDSCO queries prolong approval. Solution: Designate a dedicated regulatory liaison to manage communications.

Expert Consultation and Support

With over 25 years of experience assisting 500+ medical device companies, we specialize in guiding manufacturers and importers through the CDSCO licensing process for devices like the Pelvimeter. Our end-to-end support includes documentation preparation, test license facilitation, audit readiness, and query handling to ensure timely approvals.

Getting Started with Your CDSCO License Application for Pelvimeter

1. Assess Your Device Classification: Confirm the Pelvimeter is Class B under CDSCO’s medical device rules.

2. Prepare Documentation: Begin compiling your Device Master File and Plant Master File using our detailed guides.

3. Plan Testing: Schedule product testing at an approved laboratory early.

4. Register on CDSCO Portal: Create your account on the CDSCO MD Online Portal to access forms and submission workflows.

5. Apply for Test License (MD13): Secure the test license to commence manufacturing trials.

6. Engage a Notified Body: Identify and coordinate with a notified body from the Notified Bodies List for your audit.

7. Submit Manufacturing License Application (MD3): Once testing and audits are complete, apply for the final MD5 license.

By following these practical steps and leveraging expert advice, manufacturers and importers can efficiently navigate the CDSCO regulatory process to bring the Pelvimeter to the Indian market with confidence.

For personalized assistance or to discuss your Pelvimeter licensing strategy, feel free to contact us. Our proven track record can be your pathway to successful CDSCO approvals.