CDSCO License for Membrane fixation tack, bio absorbable

Introduction: Understanding Membrane Fixation Tack, Bio Absorbable and Its Regulatory Importance

Membrane fixation tacks, bio absorbable, are specialized medical devices used in dental regenerative procedures. Specifically, this sterile bio absorbable tack is designed to secure pliable-polymer dental regeneration membranes in situ, facilitating the regeneration of tooth-supporting structures lost due to periodontal disease or trauma. Given its critical role in dental care and its classification as a Class C device under Indian regulations, securing appropriate CDSCO licensing is imperative for manufacturers and importers aiming to market this device in India.

Navigating the CDSCO regulatory framework ensures compliance with safety, efficacy, and quality standards mandated by the Government of India. With over 25 years of experience and having guided 500+ companies through this process, we provide practical insights and detailed steps to help you obtain your license efficiently.

CDSCO Regulatory Framework for Bio Absorbable Membrane Fixation Tacks

The Central Drugs Standard Control Organization (CDSCO) regulates medical devices in India under the Medical Device Rules (MDR) 2017. The bio absorbable membrane fixation tack falls under the dental device category and is notified under Notification 29/Misc./03/2020-DC (140) Part-5 dated 10.10.2022.

As a Class C device, it is considered medium to high risk and thus requires a manufacturing license from the Central Licensing Authority via the MD9 license route. This classification mandates stringent compliance with quality systems, product testing, and regulatory audits.

For detailed device classification reference, you can consult the Medical Device Classification guide.

Risk Classification and License Requirements for Class C Devices

Class C devices like the bio absorbable membrane fixation tack require an MD9 Manufacturing License, issued by the CDSCO Central Licensing Authority. The license application involves rigorous evaluation, including:

• Obtaining a Test License (Form MD13) prior to product testing
• Conducting product testing at CDSCO-approved laboratories
• Preparing comprehensive technical documentation
• An on-site audit by CDSCO inspectors
• Addressing any queries raised during the review process

The MD9 license process usually takes approximately 4-5 months from start to finish.

Manufacturing License Process for MD9 (Class C Devices)

1. Apply for Test License (Form MD13): Initiate the process by obtaining a test license, which allows you to send samples for mandatory product testing. This stage takes about 1.5 to 2 months.

2. Product Testing: Samples must be tested at notified government laboratories listed on the CDSCO Testing Laboratories portal.

3. Prepare Technical Documentation: Assemble all required documents including Device Master File, Plant Master File, Essential Principles Checklist, and Risk Management File.

4. Submit MD9 License Application (Form MD7): Apply through the CDSCO MD Online Portal with all supporting documentation.

5. CDSCO Audit: The Central Licensing Authority will conduct an on-site audit of manufacturing facilities and quality systems.

6. Query Resolution: Respond promptly to any queries from CDSCO or the audit team.

7. Grant of License: Upon satisfactory review, the MD9 license will be issued.

Manufacturing License Documents Required for Bio Absorbable Membrane Fixation Tacks

To ensure smooth processing, the following documents must be meticulously prepared:

• Company Constitution Documents: Incorporation certificate, partnership deed, or equivalent.
• Proof of Ownership or Lease of Premises: Valid documents demonstrating right to manufacture at the proposed site.
• Details of Technical Staff: Qualification and experience certificates of competent personnel.
• Fire NOC and Pollution Control NOC: Compliance certificates from relevant authorities.
• Device Master File (DMF): Detailed product design, manufacturing process, and control measures. Our Device Master File guide provides in-depth assistance.
• Plant Master File (PMF): Documentation of manufacturing facility and quality systems. See our Plant Master File guide for best practices.
• Essential Principles Checklist: Declaration of conformity with essential principles.
• Risk Management File: Evidence of risk analysis and mitigation strategies as per ISO 14971 standards. For more, visit our Risk Management resource.
• Test Reports: From CDSCO-approved laboratories.
• Product Labels and Instructions For Use (IFU): Drafts complying with regulatory requirements.
• Quality Management System Documentation: ISO 13485 certification and related procedures.

Import License Process (MD15) for Bio Absorbable Membrane Fixation Tacks

If you are an importer and intend to bring the device into India, an Import License (Form MD14) is mandatory. The MD15 license is issued by CDSCO’s Central Licensing Authority and typically takes 5-6 months.

Key steps include:

• Preparing the required import license documentation
• Application submission through the CDSCO MD Online Portal
• Resolution of any departmental queries
• Final license grant

Unlike manufacturing licenses, a test license is not required for imports. Required documents include:

• Valid manufacturing license from the country of origin
• Free Sale Certificate
• ISO 13485:2016 certification
• CE Certificate or equivalent
• Device Master File and Plant Master File
• Wholesale drug license (if applicable)
• Company Constitution and address proof

Government fees vary by risk class, with Class C & D devices attracting higher fees. Refer to our detailed Import License guide for a comprehensive overview.

Timeline and Processing Duration

Government Fees and Costs

For the MD9 manufacturing license (Class C), the fee structure is as follows:

• Application Fee: INR 50,000
• Per Product Fee: INR 1,000

These fees are payable online during the application submission on the CDSCO MD Online Portal.

Additional costs to consider:

• Testing laboratory fees
• Audit and consultancy expenses
• Preparation of technical documentation

Budgeting accurately for these expenses helps avoid delays.

Common Challenges and Solutions

Challenge: Delays in obtaining test reports due to limited approved labs.

Solution: Plan sample submission early and select labs from the official CDSCO Testing Laboratories list to expedite testing.

Challenge: Non-compliance in technical documentation causing audit objections.

Solution: Rely on expert consultancy and use comprehensive templates for Device and Plant Master Files.

Challenge: Queries from CDSCO leading to prolonged approval times.

Solution: Maintain open communication with CDSCO and submit detailed, prompt responses.

Challenge: Understanding regulatory updates and notifications.

Solution: Regularly review CDSCO notifications and consult experienced regulatory professionals.

Expert Consultation and Support

With decades of experience supporting over 500 medical device companies, we specialize in guiding manufacturers and importers of Class C devices like the bio absorbable membrane fixation tack through every stage of CDSCO licensing.

Our services include:

• Documentation preparation and review
• Regulatory strategy and submission
• Coordination with CDSCO and notified bodies
• Assistance in audit readiness
• Post-approval compliance support

Engaging expert consultants mitigates risks and accelerates your path to market.

Getting Started with Your CDSCO License Application

1. Assess Your Device Classification: Confirm your device as Class C under CDSCO’s guidelines.

2. Gather Preliminary Documents: Company incorporation, manufacturing site details, and technical staff credentials.

3. Apply for Test License (MD13): Submit your application for the test license on the CDSCO MD Online Portal.

4. Arrange Product Testing: Coordinate with CDSCO-approved labs to conduct mandatory testing.

5. Prepare Technical Documentation: Utilize our Device Master File and Plant Master File guides to develop comprehensive files.

6. Submit MD9 License Application (Form MD7): Upload all documents and pay the requisite fees through the CDSCO portal.

7. Prepare for Audit: Ensure your manufacturing facility and QMS are audit-ready.

8. Respond to Queries Promptly: Engage with CDSCO authorities and provide clarifications as needed.

By following these practical steps and leveraging expert support, you can efficiently obtain your MD9 license and successfully commercialize your bio absorbable membrane fixation tack in India’s growing dental device market.

For personalized regulatory assistance, reach out to our specialized team to streamline your CDSCO application journey.