CDSCO License for Polymeric Surgical Mesh

Comprehensive Guide to CDSCO Licensing for Polymeric Surgical Mesh (Class C Medical Device)

Polymeric surgical meshes are critical internal prosthetic replacements used widely in surgeries for tissue reinforcement and repair. These devices, comprising absorbable and non-absorbable polymeric fibers co-knit into a durable mesh structure, demand stringent regulatory compliance due to their direct interaction with internal tissues. Navigating the CDSCO regulatory landscape for such Class C devices can be challenging without expert insights. With over 25 years of experience assisting 500+ companies, we provide you with an in-depth, actionable roadmap to secure your CDSCO license efficiently.

CDSCO Regulatory Framework for Polymeric Surgical Mesh

The Central Drugs Standard Control Organization (CDSCO) governs the import and manufacturing of medical devices in India. Polymeric surgical mesh falls under Class C, categorized as an internal prosthetic replacement due to its invasive nature and medium to high risk profile. Regulatory oversight involves a centralized approval process under the Medical Device Rules, 2017, as specified in Notification 29/Misc/3/2017-DC (292), dated 06.06.2018.

The CDSCO mandates a comprehensive evaluation consisting of safety, efficacy, and quality assessments to ensure patient safety before market authorization.

Risk Classification and License Requirements

Class C devices, like the polymeric surgical mesh, demand a rigorous licensing pathway due to their moderate risk classification. The key regulatory requirement is obtaining the MD9 Manufacturing License granted by the Central Licensing Authority.

• License Type: MD9 (Manufacturing License for Class C & D Devices)
• Application Form: MD7
• Authority: Central Licensing Authority (CDSCO HQ)
• Typical Timeline: 4-5 months
• Fees: ₹50,000 per application + ₹1,000 per product

For importers, an MD15 Import License is also necessary, which we will cover later.

Manufacturing License Process (MD9)

The MD9 license process is methodical and involves multiple steps ensuring compliance with Indian and international standards:

1. Test License (Form MD13): Before full manufacturing licensure, obtain a test license for 1.5-2 months.
2. Product Testing: Conduct mandatory product testing at government-approved laboratories. Testing includes biocompatibility, tensile strength, and sterility tests relevant to polymeric mesh devices.
3. Document Preparation: Compile a comprehensive dossier including Device Master File, Plant Master File, risk management, and QMS documentation.
4. Application Submission: File your MD9 license application using Form MD7 via the CDSCO MD Online Portal.
5. Inspection and Audit: CDSCO inspectors conduct audits of manufacturing facilities and documentation.
6. Query Resolution: Address any queries or observations raised during the audit.
7. License Grant: Upon satisfactory review, the MD9 manufacturing license is granted on Form MD9.

Manufacturing License Documents Required

Accurate and complete documentation is critical to avoid delays. For polymeric surgical mesh, the following documents are essential:

• Company Constitution and Incorporation Certificates
• Proof of Ownership or Lease Agreement of Manufacturing Premises
• Details and Qualifications of Technical Staff
• Fire and Pollution No Objection Certificates (NOCs)
• Device Master File (DMF) detailing design, material specifications, and manufacturing processes. Our detailed Device Master File guide can assist you.
• Plant Master File (PMF) outlining manufacturing environment and equipment. Refer to our Plant Master File guide.
• Essential Principles Checklist confirming compliance with Indian medical device standards
• Risk Management File documenting hazard analysis and mitigation per ISO 14971 standards. Learn more about Risk Management.
• Test Reports from approved laboratories (List of Testing Laboratories)
• Product Labeling, Instructions for Use (IFU), and Packaging details
• Quality Management System (QMS) Certificates, preferably ISO 13485:2016

Ensure that all files are consistent, verifiable, and reflect the technical and regulatory compliance of your device.

Import License Process (MD15)

For companies importing polymeric surgical mesh into India, obtaining an MD15 Import License from CDSCO is mandatory:

• Submit application via Form MD14 on the CDSCO MD Online Portal.
• Unlike manufacturing licenses, no test license (MD13) is needed, but extensive documentation must be provided.
• CDSCO reviews technical documentation, manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016, CE Certificates, and other compliance records.
• Post review, queries may be raised that require prompt resolution.
• The import license is granted on Form MD15.

Import License Documents Required

Key documents for importers include:

• Valid Manufacturing License of the device in the exporting country
• Free Sale Certificate
• ISO 13485:2016 Certification
• CE Certificate or equivalent regulatory approval
• Device Master File and Plant Master File
• Wholesale Drug License
• Company Constitution Documents

Fees applicable vary by device risk class and number of products:

• Class C & D devices: ₹3,00,000 per site + ₹1,50,000 per product

Timeline and Processing Duration

For import license (MD15), the process typically takes 5-6 months given the extensive document review.

Government Fees and Costs

• MD9 License Application: ₹50,000
• Per Product Fee: ₹1,000
• Test License (MD13): Included in the process, but separate fees may apply

Additional indirect costs include:

• Laboratory testing fees at government-approved facilities
• Notified body audit charges
• Consultancy fees if availing expert support

Budgeting accurately for these expenses is vital to avoid surprises.

Common Challenges and Solutions

Challenge 1: Delays in Testing and Audit

• Solution: Pre-select approved laboratories with capacity and schedule testing well in advance.

Challenge 2: Incomplete Documentation

• Solution: Utilize checklists and expert reviews to ensure completeness, especially for DMF and PMF.

Challenge 3: Non-compliance in QMS or Risk Management

• Solution: Implement robust systems aligned with ISO 13485 and ISO 14971 standards. Our Risk Management resource is helpful.

Challenge 4: Audit Observations

• Solution: Prepare your facility and staff thoroughly, conduct mock audits, and maintain transparent communication with CDSCO inspectors.

Expert Consultation and Support

Leveraging the experience of consultants who have successfully guided over 500 companies through the CDSCO licensing maze can drastically reduce timelines and ensure compliance. We offer end-to-end support including:

• Document preparation and review
• Coordination with notified bodies and testing labs
• Audit preparedness training
• Query handling and liaison with CDSCO

Our expertise ensures your polymeric surgical mesh reaches the Indian market swiftly and compliantly.

Getting Started with Your CDSCO License Application

1. Assess your device classification: Confirm that your polymeric surgical mesh is Class C.
2. Initiate the Test License (MD13): Submit the application via the CDSCO MD Online Portal.
3. Select Testing Laboratories: Choose government-approved labs from the official list of testing laboratories.
4. Prepare Documentation: Develop your Device Master File and Plant Master File using our detailed guides.
5. Apply for MD9 License (Form MD7): After successful testing, submit your manufacturing license application.
6. Prepare for Audit: Schedule and prepare for the CDSCO inspection.
7. Respond Promptly to Queries: Ensure timely resolution of all CDSCO or notified body queries.

Starting early and engaging expert help can make this complex regulatory process manageable and efficient. For tailored assistance, connect with our regulatory experts to streamline your polymeric surgical mesh license application.

Embark on your CDSCO licensing journey today and position your medical device for success in the rapidly growing Indian healthcare market.