CDSCO License for Mesh system instruments

Comprehensive Guide to CDSCO Licensing for Mesh System Instruments (Class A Medical Devices)

Mesh system instruments such as mesh holders, pushers, curved pushers, and cutters play a crucial role in assisting surgeons during pelvic floor procedures. While the mesh itself is not part of the instrument system, these surgical aids fall under the Class A – Low Risk medical device category, specifically within the General Hospital or Orthopaedic Instruments classification. As per the CDSCO notification 29/Misc./03/2020-DC (193)- Part-3 dated 16.03.2022, these devices require regulatory approval before market entry in India.

With over 25 years of experience and having guided more than 500 companies through the CDSCO licensing maze, we understand the nuances of the process for such medical devices. This detailed guide will walk you through the regulatory framework, document requirements, timelines, costs, and practical tips to successfully obtain the MD5 Manufacturing License for your Mesh System Instruments.

CDSCO Regulatory Framework for Mesh System Instruments (Class A)

The Central Drugs Standard Control Organization (CDSCO) regulates medical devices under the Medical Device Rules (MDR), 2017. Mesh system instruments, classified as Class A devices, fall under the purview of the State Licensing Authority for manufacturing licenses.

Regulatory compliance ensures safety, quality, and efficacy while providing a competitive advantage in the Indian healthcare market. The regulatory journey involves multiple steps including testing, documentation, audit, and license issuance.

Risk Classification and License Requirements for Mesh System Instruments

Your Mesh System Instruments are classified under Class A (Low Risk) based on their intended use and risk profile. This classification mandates obtaining the MD5 Manufacturing License under Form MD3 from the State Licensing Authority.

• License Type: MD5 (Manufacturing License for Class A & B devices)
• Application Form: MD3
• Authority: State Licensing Authority
• Total Timeline: Approximately 3-4 months
• Fees: Rs 5,000 per application + Rs 500 per product

The MD5 license process includes a preliminary Test License (Form MD13), product testing from government-approved labs, documentation submission, audit by a notified body, and license grant.

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

Manufacturing License Process for Mesh System Instruments (MD5)

1. Obtain Test License (Form MD13): Before manufacturing, apply for a test license which takes around 1.5 to 2 months to process.
2. Product Testing: Conduct mandatory testing of your mesh system instruments at CDSCO-approved laboratories. You can find the list of authorized Testing Laboratories here.
3. Documentation Preparation: Compile all technical and quality documents.
4. Application Submission (Form MD3): Submit your manufacturing license application via the CDSCO MD Online Portal.
5. Audit by Notified Body: The notified body will audit your manufacturing facility and quality systems. See the list of Notified Bodies for MD5 audits.
6. Queries Resolution: Address any queries or deficiencies raised by the licensing authority or notified body.
7. License Grant (Form MD5): Upon successful compliance, the license will be granted.

Manufacturing License Documents Required for Mesh System Instruments

To ensure a smooth application process, prepare the following key documents:

• Company Constitution: Incorporation certificate, partnership deed, or relevant business registration.
• Proof of Premises Ownership: Rent agreement or ownership documents.
• Technical Staff Qualification: CVs and qualifications of manufacturing and quality control personnel.
• Fire NOC & Pollution Control NOC: Relevant clearances from local authorities.
• Device Master File (DMF): Detailed technical specifications of the mesh system instruments. Our Device Master File guide provides full insight.
• Plant Master File (PMF): Manufacturing process, equipment, and quality systems. Learn more from our Plant Master File guide.
• Essential Principles Checklist: Compliance with Indian Medical Device Rules and standards.
• Risk Management File: Documented risk analysis and mitigation strategies.
• Test Reports: Certificates from government-approved labs.
• Labels and Instructions for Use (IFU): As per regulatory requirements.
• Quality Management System (QMS) Documents: SOPs, quality manuals, and records.

Organizing these documents meticulously can prevent delays during audit and review.

Import License Process for Mesh System Instruments (MD15)

If you plan to import mesh system instruments into India rather than manufacture locally, you will need an MD15 Import License issued by the Central Licensing Authority.

The import license process is comparatively straightforward but requires comprehensive documentation, including manufacturing licenses from the country of origin, ISO certifications, and Free Sale Certificates.

• Application Form: MD14
• Timeline: Approximately 5-6 months
• Fees: Vary by class and product quantity

For detailed steps, please refer to our Import License guide.

Import License Documents Required for Mesh System Instruments

Key documents you must gather include:

• Valid Manufacturing License of the device in the country of origin.
• Free Sale Certificate from the country of origin.
• ISO 13485:2016 Certification.
• CE Certificate (if applicable).
• Device Master File and Plant Master File.
• Wholesale License (if applicable).
• Company Constitution and ownership proof.

Preparing these documents early will facilitate a seamless import license application.

Timeline and Processing Duration

Prompt communication with notified bodies and timely responses to queries can significantly reduce overall processing time.

Government Fees and Costs

For Class A devices like mesh system instruments, the fee structure is as follows:

• Application Fee: Rs 5,000 per application
• Product Fee: Rs 500 per product

Additional costs to factor in include testing fees at government-approved labs and audit fees payable to notified bodies.

Budgeting for these expenses upfront ensures no surprises during the licensing journey.

Common Challenges and Solutions

Challenge: Delays due to incomplete documentation or non-compliance with audit findings.

Solution: Engage experienced regulatory consultants to review documents before submission and prepare your team for audits.

Challenge: Difficulty in scheduling audits with notified bodies.

Solution: Plan audit appointments well in advance and maintain good communication with the notified body.

Challenge: Product testing turnaround times.

Solution: Select testing laboratories with proven track records for timely service. Refer to the Testing Laboratories list.

Expert Consultation and Support

Navigating the CDSCO licensing process for mesh system instruments can be complex. With over 25 years of industry experience, we offer end-to-end support:

• Gap analysis and documentation support
• Liaison with notified bodies and CDSCO officials
• Training for internal teams on compliance
• Post-license regulatory maintenance

Our clients have benefited from reduced timelines and hassle-free approvals by leveraging our expertise.

Getting Started with Your CDSCO License Application for Mesh System Instruments

1. Assess your device classification: Confirm that your mesh system instruments are Class A.
2. Gather core documents: Company registration, premises proof, technical staff details.
3. Apply for Test License (Form MD13): Submit via the CDSCO MD Online Portal.
4. Initiate product testing: Engage with approved laboratories early.
5. Prepare comprehensive Device and Plant Master Files: Ensure adherence to essential principles.
6. Schedule notified body audit: Coordinate timelines to avoid delays.
7. Submit manufacturing license application (Form MD3): Complete with all supporting documents.
8. Respond promptly to queries: Expedite license grant.

By following these steps and leveraging expert guidance, manufacturers can confidently bring their mesh system instruments to the Indian market efficiently and compliantly.

For more information on the MD5 licensing process, visit our MD5 License Guide.

Embark on your CDSCO licensing journey today and ensure your mesh system instruments meet India’s stringent regulatory standards with ease and confidence.