CDSCO License for Hyaluronidase solution

Comprehensive Guide to CDSCO Licensing for Hyaluronidase Solution (Class C Medical Device)

As seasoned regulatory consultants with over 25 years of experience helping more than 500 companies navigate the CDSCO licensing maze, we understand the critical nuances involved in bringing specialized devices like the Hyaluronidase solution to the Indian market. This enzymatic solution, used primarily in assisted reproductive procedures such as ICSI (Intra Cytoplasmic Sperm Injection), falls under Class C risk classification due to its therapeutic implications and biological components.

Understanding Hyaluronidase Solution and Its Regulatory Importance

Hyaluronidase solution is an obstetrical and gynecological device designed for the denudation of cumulus cells surrounding oocytes, facilitating assisted reproductive technologies. Given its bovine-derived enzyme content and use in invasive procedures, regulatory compliance ensures patient safety, quality assurance, and market legitimacy. The CDSCO notification (File No. 29/Misc./03/2020-DC (181), dated 03.06.2022) mandates stringent controls aligning with international standards.

CDSCO Regulatory Framework for Class C Devices like Hyaluronidase Solution

In India, medical devices are regulated under the Medical Device Rules (MDR) 2017, supervised by the Central Drugs Standard Control Organization (CDSCO). Hyaluronidase solution, classified as Class C, requires central licensing authority approval due to its moderate to high risk profile. This classification demands rigorous evaluation, including product testing, technical document scrutiny, and manufacturing site audits.

Risk Classification and License Requirements for Hyaluronidase Solution

• Risk Class: C
• Required Manufacturing License: MD9 (Form MD7)
• Required Import License (if applicable): MD15 (Form MD14)

Class C devices necessitate an MD9 manufacturing license granted by the CDSCO central authority. The process involves a multi-stage review including test license acquisition (MD13), product testing at government-approved labs, document submission, and factory audits.

Step-by-Step Manufacturing License Process (MD9) for Hyaluronidase Solution

1. Test License Application (Form MD13): Before full manufacturing license submission, apply for a test license to conduct product testing. This takes approximately 1.5 to 2 months.
2. Product Testing: Send samples to CDSCO-recognized testing laboratories to validate safety and efficacy. Refer to the Testing Laboratories list for approved facilities.
3. Document Preparation: Prepare comprehensive technical dossiers including Device Master File, Plant Master File, Essential Principles Checklist, and Risk Management File.
4. License Application (Form MD7): Submit the MD9 application through the CDSCO MD Online Portal. Include all required documents and test reports.
5. Factory Audit: CDSCO inspectors conduct an on-site audit to verify compliance with Good Manufacturing Practices (GMP) and QMS.
6. Query Resolution: Address any questions or deficiencies raised during the audit or document review.
7. Grant of License (Form MD9): Upon satisfactory evaluation, CDSCO issues the manufacturing license.

Essential Documents Required for MD9 License Application

• Company constitution and incorporation documents
• Proof of ownership or lease of manufacturing premises
• Qualification and experience certificates of technical staff
• Fire and Pollution NOCs
• Device Master File (technical specifications, design, manufacturing process) - our detailed Device Master File guide can assist
• Plant Master File describing manufacturing infrastructure and quality systems (Plant Master File Guide)
• Essential Principles Checklist confirming compliance with Indian MDR requirements
• Risk Management File detailing hazard analysis and mitigation (Risk Management Insights)
• Product test reports from CDSCO-approved labs
• Product labels and Instructions for Use (IFU)
• Quality Management System (QMS) documentation, preferably ISO 13485 compliant

Import License Process (MD15) for Hyaluronidase Solution

If you plan to import Hyaluronidase solution into India, an MD15 license from CDSCO's central authority is mandatory. The steps include:

1. Document Compilation: Ensure possession of a valid manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016 certification, CE certification (if applicable), Device Master File, Plant Master File, wholesale license, and company incorporation docs.
2. Application Submission: Apply via the CDSCO MD Online Portal using Form MD14.
3. Review and Query Resolution: CDSCO reviews documents and may raise queries.
4. License Grant: Upon clearance, the import license (Form MD15) is issued.

Documents Required for MD15 Import License

• Valid foreign Manufacturing License
• Free Sale Certificate from country of origin
• ISO 13485:2016 Certificate
• CE Certificate (if applicable)
• Device and Plant Master Files
• Wholesale Drug License in India
• Company Constitution Documents

Timeline and Processing Duration for Hyaluronidase Solution Licensing

The entire manufacturing license process, including test license and audits, typically takes 4-5 months, while import licensing requires around 5-6 months.

Government Fees and Cost Breakdown

These fees are payable online through the CDSCO portal during application submission.

Common Challenges Faced by Manufacturers and Practical Solutions

• Complex Documentation: Many companies struggle with assembling exhaustive Device and Plant Master Files. Utilizing expert templates and guidance, such as our Device Master File guide, can streamline this process.
• Delays in Product Testing: Samples may be rejected or delayed if not prepared according to lab requirements. Engaging with CDSCO-approved testing labs early is critical.
• Audit Non-compliance: Manufacturing sites often miss critical GMP standards. Pre-audit consultancy and mock inspections can significantly improve outcomes.
• Query Resolution Bottlenecks: Slow or incomplete responses to CDSCO queries can stall approvals. Assigning a dedicated regulatory liaison ensures timely communication.

Expert Consultation and Support

Our extensive experience with over 500 successful CDSCO license applications positions us uniquely to assist manufacturers and importers of Hyaluronidase solution. We offer end-to-end support:

• Gap analysis and documentation preparation
• Coordination with testing laboratories
• Application submission and tracking via the CDSCO MD Online Portal
• Pre-audit readiness and post-audit compliance
• Query management and liaison with CDSCO authorities

Getting Started with Your CDSCO License Application for Hyaluronidase Solution

To initiate your journey:

1. Classify your device rigorously: Confirm Class C status using the Medical Device Classification resource.
2. Plan your testing and documentation: Apply promptly for the MD13 test license. Begin compiling Device and Plant Master Files, QMS documents, and risk management plans.
3. Select CDSCO-approved testing labs: Early engagement with labs listed here Testing Laboratories helps avoid delays.
4. Prepare for audit: Implement GMP and ISO 13485 standards in your facility.
5. Submit your application: Use the CDSCO MD Online Portal for all licensing applications.

By following these actionable steps and leveraging expert support, manufacturers and importers can navigate the regulatory process efficiently, ensuring timely market access for their Hyaluronidase solution.

For personalized assistance or to learn more about our comprehensive CDSCO licensing services, please contact our regulatory experts today.