CDSCO License for Bio Patches

Comprehensive Guide to CDSCO Licensing for Bio Patches (Class C Medical Device)

Bio Patches, categorized under Internal Prosthetic Replacements, are specialized medical devices intended for the reconstruction and repair of defects of the pericardium. Given their critical role and implantable nature, they are classified as Class C devices by the Central Drugs Standard Control Organisation (CDSCO) in India. Navigating the regulatory pathway for such devices requires meticulous preparation and understanding of CDSCO’s regulatory framework. With over 25 years of expertise assisting 500+ manufacturers and importers, we provide you with a detailed roadmap to secure your manufacturing and import licenses for Bio Patches efficiently.

CDSCO Regulatory Framework for Bio Patches

Bio Patches fall under the ambit of implantable internal prosthetic devices, which are stringently regulated due to their direct contact with internal tissues and potential risk to patient safety. CDSCO regulates these devices through a structured licensing system, ensuring compliance with Indian Medical Device Rules, 2017, aligned with international standards.

For Class C devices like Bio Patches, the manufacturing license is granted by the Central Licensing Authority via the MD9 license (Form MD7), while import licenses are issued through the MD15 license (Form MD14). Both licenses require thorough documentation, product testing, and audits to guarantee the safety, efficacy, and quality of the product.

Risk Classification and License Requirements for Bio Patches

As per CDSCO’s classification:

Device Name: Bio Patches
Risk Class: Class C (Moderate to High Risk)
Category: Internal Prosthetic Replacements
Notification: 29/Misc/3/2017-DC (292), dated 06.06.2018

Class C devices require:

MD9 Manufacturing License (central level approval)
MD15 Import License (if applicable)

This classification mandates rigorous conformity assessment, including product testing from CDSCO-approved labs and inspection audits.

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

Manufacturing License Process for Bio Patches (MD9)

Step 1: Obtain Test License (Form MD13)

Before applying for the MD9 license, it is mandatory to acquire a test license for Bio Patches on Form MD13. This license authorizes the manufacturer to produce samples for testing.

Timeline: Approximately 1.5 to 2 months

Step 2: Product Testing

Samples must be tested at CDSCO-approved testing laboratories to ensure compliance with safety and performance standards.

Access the list of CDSCO-approved testing laboratories.
Testing duration varies but generally takes 4 to 6 weeks depending on the complexity.

Step 3: Document Preparation

Prepare a comprehensive submission package, including technical files and quality system documents.

Step 4: Application Submission (Form MD7)

Submit the MD9 manufacturing license application through the CDSCO MD Online Portal.

Step 5: Audit by CDSCO Inspectors

A thorough audit of manufacturing premises, quality management systems, and technical documentation is conducted by CDSCO inspectors.

Step 6: Query Resolution

Address any queries or observations raised by the department during the audit.

Step 7: License Grant (Form MD9)

Upon satisfactory compliance, the MD9 manufacturing license is granted.

Manufacturing License Documents Required for Bio Patches

For Class C Bio Patches, the following documents must be meticulously compiled:

Company Constitution (Incorporation Certificate, Memorandum & Articles of Association)
Proof of Ownership or Lease Agreement for Manufacturing Premises
Details and Qualification Certificates of Technical Staff
No Objection Certificates (NOC) for Fire Safety and Pollution Control
Device Master File (DMF) detailing product design, specifications, and manufacturing processes
Plant Master File (PMF) describing the manufacturing site and equipment
Essential Principles Checklist confirming compliance with regulatory standards
Risk Management File tailored to Bio Patches’ specific risks
Product Test Reports from CDSCO-approved labs
Labels and Instructions for Use (IFU) according to regulatory guidelines
Quality Management System (QMS) Documents, preferably ISO 13485:2016 certified

Our Device Master File guide and Plant Master File guide provide exhaustive expertise on preparing these critical documents.

Import License Process for Bio Patches (MD15)

Importers aiming to bring Bio Patches into India must obtain an MD15 import license from the Central Licensing Authority.

Step 1: Document Preparation

Compile all required documents including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016 certification, CE Certificate (if applicable), and technical files.

Step 2: Application Submission

Submit the MD15 application (Form MD14) via the CDSCO MD Online Portal.

Step 3: Query Resolution

Respond promptly to any departmental queries to avoid delays.

Step 4: License Issuance

Once all requirements are met, the import license is granted.

Import License Documents Required for Bio Patches

Valid Manufacturing License (MD9 or equivalent) from the country of origin
Free Sale Certificate
ISO 13485:2016 Certification
CE Certificate (if applicable)
Device Master File
Plant Master File
Wholesale License
Company Constitution Documents

Refer to our detailed Import License guide for more insights.

Timeline and Processing Duration

Process Stage	Duration
Test License (MD13)	1.5 – 2 months
Product Testing	4 – 6 weeks
Document Preparation	3 – 4 weeks
Application Processing	1 – 1.5 months
Audit & Inspection	3 – 4 weeks
Query Resolution	2 – 3 weeks
Total Estimated Time	Approximately 4 – 5 months

Import license processing typically takes 5 to 6 months.

Government Fees and Costs

MD9 Manufacturing License Fees

Application Fee: INR 50,000
Fees per product: INR 1,000

MD15 Import License Fees

For Class C devices like Bio Patches:
- Site Fee: USD 3,000
- Product Fee: USD 1,500 per product

Note that additional costs such as testing fees, audit fees, and consultancy charges may apply.

Common Challenges and Solutions

Delayed Testing Reports: Testing at government labs can be time-consuming. To mitigate, submit samples well in advance and maintain close communication with testing labs.
Documentation Gaps: Incomplete or inconsistent documentation is a frequent cause of delays. Leverage our extensive experience to prepare thorough Device and Plant Master Files.
Audit Non-compliance: Audit findings often relate to quality system lapses. Implement robust QMS aligned with ISO 13485 before application.
Query Resolution Delays: Prompt and detailed responses are critical. Assign dedicated personnel to manage regulatory communications.

Expert Consultation and Support

With over 25 years of experience and having supported more than 500 companies, we provide end-to-end assistance including:

Gap analysis and documentation review
Preparation of Device and Plant Master Files
Coordination with CDSCO and notified bodies
Guidance on testing and audit preparedness
Post-approval compliance support

Engage with our experts early in your licensing journey to avoid pitfalls and accelerate market entry.

Getting Started with Your CDSCO License Application for Bio Patches

Assess Your Device Classification: Confirm Class C status and understand specific regulatory requirements.
Prepare Documentation: Begin compiling your technical files, DMF, PMF, and QMS documentation.
Apply for Test License (MD13): Submit your test license application through the CDSCO MD Online Portal.
Coordinate Product Testing: Send product samples to CDSCO-approved labs promptly.
Plan for Audit: Schedule internal audits and corrective actions to ensure compliance before CDSCO inspection.
Submit Manufacturing License Application (MD9): Once testing and documentation are complete, apply for the MD9 license.
Prepare for Import License (MD15) if applicable: Collect all required import documents and initiate the application process.

Starting early and maintaining a proactive approach can significantly reduce approval timelines. We recommend leveraging our experienced consultancy services to guide you through each step seamlessly.

For personalized support, connect with our regulatory experts today and take confident strides towards successful licensing of your Bio Patches in India.