CDSCO License for Crosslinked sodium hyaluronate

Comprehensive Guide to CDSCO Licensing for Crosslinked Sodium Hyaluronate (Class C Medical Device)

Crosslinked sodium hyaluronate is an advanced viscoelastic supplement used as a replacement for synovial fluid in human joints, primarily indicated for alleviating symptoms of joint dysfunctions such as osteoarthritis. Functioning through lubrication and mechanical support, it falls under the category of disposable hypodermic syringes and is classified as a Class C medical device by CDSCO, notified under 29/Misc/3/2017-DC (18) dated 16.08.2018.

Navigating the Indian regulatory landscape for medical devices can be complex, especially for Class C products like crosslinked sodium hyaluronate. With over 25 years of expertise and having supported 500+ companies in securing CDSCO licenses, we bring you a detailed, practical roadmap to help manufacturers and importers successfully enter the Indian market.

CDSCO Regulatory Framework for Crosslinked Sodium Hyaluronate

The Central Drugs Standard Control Organization (CDSCO) governs the approval and licensing of medical devices in India. For Class C devices, the regulatory oversight is centralized, requiring compliance with stringent guidelines including product testing, documentation, and audits by CDSCO inspectors.

This framework ensures that devices like crosslinked sodium hyaluronate meet safety, efficacy, and quality standards before reaching patients, a critical step given its intra-articular use and potential impact on patient health.

Risk Classification and License Requirements

Crosslinked sodium hyaluronate is classified as a Class C medical device, which denotes a moderate to high risk level. According to CDSCO:

• Risk Class: C
• License Type: MD9 Manufacturing License
• Authority: Central Licensing Authority

Class C devices require a comprehensive regulatory pathway, including:

• Obtaining a Test License (MD13) for product testing
• Product testing from CDSCO-approved laboratories
• Submission of detailed documentation including Device Master File and Plant Master File
• Successful audit by CDSCO inspectors

For detailed classification criteria, refer to our Medical Device Classification guide.

Manufacturing License Process (MD9)

The manufacturing license for Class C devices is granted via the MD9 license, applied through Form MD7. The process involves the following steps:

1. Apply for Test License (Form MD13): Allows manufacturing of samples for testing. This takes approximately 1.5 to 2 months.
2. Product Testing: Conducted in CDSCO-approved laboratories to verify compliance with standards. Testing duration varies but generally completes within 1 month.
3. Document Preparation: Compilation of all mandatory documents including Device Master File, Plant Master File, Essential Principles Checklist, Risk Management File, and Quality Management System (QMS) documents.
4. Submit MD9 Application (Form MD7): Through the CDSCO MD Online Portal.
5. Audit: CDSCO inspectors conduct an on-site audit of manufacturing facilities and quality systems.
6. Queries and Clarifications: Address any observations or queries raised by the CDSCO.
7. Grant of License: Issuance of MD9 license upon satisfactory completion.

For a step-by-step overview, our MD9 License Guide offers in-depth insights.

Manufacturing License Documents Required

Successful application mandates submission of the following key documents:

• Company Constitution: Incorporation certificates, partnership deed, or memorandum and articles of association.
• Proof of Premises Ownership or Lease: Valid legal documents proving possession of manufacturing site.
• Technical Staff Details: Qualification and experience certificates of key technical personnel involved.
• Fire No Objection Certificate (NOC): From local fire department.
• Pollution Control Board NOC: Environmental clearance.
• Device Master File (DMF): Detailed description of device design, manufacturing process, and quality controls. Learn how to prepare a DMF in our Device Master File guide.
• Plant Master File (PMF): Documentation of manufacturing environment, equipment, and procedures. See our Plant Master File Guide.
• Essential Principles Checklist: Compliance with CDSCO essential principles.
• Risk Management File: Hazard analysis, risk evaluation, and mitigation strategies.
• Test Reports: From CDSCO-approved laboratories confirming product safety and performance.
• Labels and Instructions for Use (IFU): Sample labels and user manuals.
• Quality Management System Documents: ISO 13485 certification, SOPs, CAPA, internal audit reports, etc.

Comprehensive preparation of these documents minimizes delays and audit observations.

Import License Process (MD15)

If your company plans to import crosslinked sodium hyaluronate into India, obtaining an MD15 import license is mandatory. This process is governed by the Central Licensing Authority.

Key steps include:

1. Document Preparation: Since test license is not needed for import, prepare all relevant documents including manufacturing license from the country of origin, free sale certificate, ISO 13485:2016, CE certificate, Device Master File, Plant Master File, wholesale license, and company constitution.
2. Application Submission: Apply via Form MD14 on the CDSCO MD Online Portal.
3. Department Review and Queries: Address any clarifications.
4. Grant of MD15 License: Typically within 5-6 months.

For details on import licensing, see our Import License Guide.

Import License Documents Required

• Valid Manufacturing License from country of origin
• Free Sale Certificate
• ISO 13485:2016 Certification
• CE Certificate (if applicable)
• Device Master File
• Plant Master File
• Wholesale Drug License (if applicable)
• Company Constitution

Ensure all certificates are valid and authenticated to prevent regulatory hurdles.

Timeline and Processing Duration

*The 4-5 months for MD9 includes test license, testing, application review, and audit.

Early preparation of documents and proactive response to queries can significantly reduce delays.

Government Fees and Costs

• MD9 Manufacturing License Fees:

  • Application Fee: Rs. 50,000
  • Per Product Fee: Rs. 1,000

• Test License (MD13) Fee: As per CDSCO norms (contact CDSCO for current rates)

• Import License (MD15) Fees:

  • Class C Devices: $3,000 per site +$1,500 per product

Additional costs may include:

• Laboratory testing fees
• Notified body audit charges
• Consultancy and documentation preparation

Budgeting for these fees upfront is essential to avoid financial surprises.

Common Challenges and Solutions

1. Delays in Test License and Product Testing:

• Solution: Select CDSCO-approved testing laboratories with proven turnaround times. Refer to the official Testing Laboratories list.

2. Incomplete Documentation Leading to Audit Observations:

• Solution: Utilize expert consultants experienced in MD9 applications. Follow checklists rigorously, especially for Device Master File and Risk Management File.

3. Navigating the Audit Process:

• Solution: Prepare your facility and QMS for audit in advance. Conduct internal audits and mock inspections.

4. Addressing Regulatory Queries Promptly:

• Solution: Maintain a dedicated regulatory team to respond within stipulated timelines.

Expert Consultation and Support

With over two decades of regulatory consulting experience, we have enabled over 500 medical device manufacturers and importers to successfully navigate the CDSCO licensing process. Our services include:

• End-to-end documentation support
• Pre-audit readiness and mock audits
• Regulatory strategy and compliance advice
• Liaison with CDSCO and notified bodies

Partnering with experienced consultants can dramatically improve your approval success rate and reduce time-to-market.

Getting Started with Your CDSCO License Application

Ready to bring your crosslinked sodium hyaluronate device to the Indian market? Here are actionable next steps:

1. Evaluate Your Device Classification: Confirm Class C status and understand specific requirements.
2. Select Appropriate Licensing Pathway: For manufacturing, plan for MD9; for import, MD15.
3. Register on CDSCO MD Online Portal: Create your account at the CDSCO MD Online Portal.
4. Prepare and Compile Documents: Assemble company constitution, technical documents, test reports, and quality system files.
5. Engage with CDSCO-Approved Testing Labs: Initiate product testing early.
6. Apply for Test License (if manufacturing): Submit Form MD13.
7. Schedule Pre-Audit Preparations: Train your staff and review compliance.
8. Submit Your Application Form (MD7 for MD9 license): Monitor application status regularly.

By following these steps meticulously and leveraging expert regulatory support, your journey to obtaining the CDSCO MD9 license for crosslinked sodium hyaluronate can be efficient and successful.

For personalized assistance and comprehensive service packages, feel free to contact our regulatory team.