CDSCO License for Stocking, medical support

Comprehensive Guide to CDSCO Licensing for Stocking, Medical Support (Class A Device)

As specialists with over 25 years of experience and having assisted 500+ companies in navigating India's medical device regulatory landscape, we understand the critical importance of securing the appropriate CDSCO license for your medical devices. This guide offers detailed, actionable insights for manufacturers and importers of Stocking, Medical Support devices — classified as Class A under CDSCO regulations — ensuring a smooth market entry and compliance.

Understanding the Medical Device: Stocking, Medical Support

The Stocking, Medical Support is a rehabilitation device designed as a limb support worn on the upper or lower extremity. Its primary function is to support, correct, prevent deformity, or align body structures to improve functionality. Classified as a low-risk Class A device, it falls under the category of medical devices requiring state-level licensing via the MD5 process.

The device's notification details are as follows:

• File No.: 29/Misc./03/2020-DC (160)
• Notification Date: 04.08.2022

Given the device's risk class and intended use, compliance with CDSCO’s regulatory framework is mandatory before manufacture or import for sale in India.

CDSCO Regulatory Framework for Stocking, Medical Support

India’s Central Drugs Standard Control Organization (CDSCO) governs the regulation of medical devices. Since the notification on August 4, 2022, Stocking, Medical Support devices are regulated under the Medical Device Rules (MDR) 2017, categorizing them as Class A devices.

For Class A devices, the licensing authority lies with the State Licensing Authority and involves a detailed process encompassing testing, audit, and documentation.

Manufacturers must secure an MD5 license (Manufacturing License for Class A/B devices) to legally manufacture this device. Importers, on the other hand, require the MD15 import license from the central authority.

To understand device classification in detail, you can refer to our Medical Device Classification guide.

Risk Classification and License Requirements for Stocking, Medical Support

• Risk Class: A (Low risk)
• License Type: MD5 (Manufacturing License for Class A & B devices)
• Governing Authority: State Licensing Authority
• Typical Process Duration: Approximately 3-4 months

Class A devices such as this stocking require:

• A test license (Form MD13) initially
• Product testing at government-approved laboratories
• Documentation and audit by a notified body

This classification mandates comprehensive quality and safety checks, even though the risk is low.

Manufacturing License Process (MD5) for Class A Stocking Devices

The manufacturing license process for Class A devices like the Stocking, Medical Support involves the following steps:

1. Apply for Test License (Form MD13): This must be done first and typically takes 1.5 to 2 months to process. The test license allows limited manufacture for testing purposes.

2. Product Testing: Conduct product testing at CDSCO-approved testing laboratories to verify compliance with essential principles and safety standards. You can find the list of CDSCO-approved testing laboratories here.

3. Documentation Preparation: Prepare and collate required documents, including Device Master File (DMF), Plant Master File (PMF), risk management files, and more.

4. Apply for Manufacturing License (Form MD3 for MD5): Submit the application through the CDSCO MD Online Portal.

5. Audit by Notified Body: An audit will be conducted by a notified body to verify the manufacturing site and quality systems. Refer to the list of notified bodies for your audit requirements.

6. Address Queries: Respond promptly and comprehensively to any queries raised by the licensing authority or notified body.

7. Grant of License: Upon satisfactory completion of all steps, the license is granted on Form MD5.

For a complete walkthrough, our MD5 License Guide offers in-depth insights.

Manufacturing License Documents Required for Stocking, Medical Support

To ensure a successful application, gather the following documents:

• Company Constitution: Incorporation certificate, partnership deed, or LLP agreement
• Proof of Ownership or Tenancy of Manufacturing Premises: Rent agreement or ownership documents
• Technical Staff Credentials: Qualification and experience certificates for key personnel
• Fire NOC and Pollution Control NOC: From local authorities
• Device Master File (DMF): Detailed device description, design, manufacturing processes, and specifications. Our Device Master File guide can assist in preparation.
• Plant Master File (PMF): Information on manufacturing facilities and quality control systems. See our Plant Master File guide.
• Essential Principles Checklist: Demonstrating compliance with MDR essential principles
• Risk Management File: Risk analysis and mitigation strategies following ISO 14971. Learn more from our Risk Management resource.
• Test Reports: From CDSCO-approved laboratories
• Labels and Instructions for Use (IFU): Drafts demonstrating compliance with labeling requirements
• Quality Management System Documentation: ISO 13485:2016 certification and related SOPs

Ensuring accuracy and completeness of these documents significantly reduces processing delays.

Import License Process (MD15) for Stocking, Medical Support

While the stocking is a Class A device primarily requiring an MD5 license for manufacturing, importers must obtain an MD15 import license from the Central Licensing Authority.

Key steps include:

1. Document Preparation: Unlike manufacturing licenses, no test license is required for imports.

2. Application Submission: Submit Form MD14 for MD15 license via the CDSCO MD Online Portal.

3. Query Resolution: Address any licensing authority queries swiftly.

4. License Grant: After satisfactory review, the MD15 license is granted.

Required documents include manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016, CE Certificate, Device Master and Plant Master Files, wholesale license, and company constitution.

Detailed guidance is available in our Import License Guide.

Timeline and Processing Duration

Planning timelines realistically and initiating early can help avoid delays.

Government Fees and Costs

• Test License Fee (MD13): Included within MD5 process
• MD5 Manufacturing License Fee: Rs. 5,000 per application
• Product Fee: Rs. 500 per product (for Stocking, Medical Support, this applies per variant)

Additional costs to consider:

• Testing fees at CDSCO-approved labs
• Audit fees charged by the notified body
• Consultant fees (if availing expert support)

Budgeting accurately upfront helps in smooth financial planning.

Common Challenges and Solutions

Challenge: Delays in product testing due to lab backlogs

• Solution: Pre-book testing slots with CDSCO-approved labs early. Refer to the Testing Laboratories list.

Challenge: Incomplete documentation leads to multiple query rounds

• Solution: Use comprehensive checklists, and consider expert review before submission.

Challenge: Audit non-compliance due to inadequate QMS implementation

• Solution: Ensure ISO 13485 certification and internal audits before CDSCO inspection.

Challenge: Misclassification of device leading to incorrect license application

• Solution: Consult the official classification and seek expert advice if uncertain.

Expert Consultation and Support

With our extensive experience guiding over 500 companies through the CDSCO licensing maze, we offer:

• Personalized gap analysis and documentation support
• Assistance in coordinating product testing and audit
• Strategic planning to meet timelines and regulatory expectations
• Liaison with CDSCO officials to expedite application processing

Our proven track record demonstrates our commitment to helping you achieve compliance efficiently.

Getting Started with Your CDSCO License Application for Stocking, Medical Support

To initiate your CDSCO licensing journey for the Stocking, Medical Support device, follow these practical steps:

1. Assess Device Classification: Confirm your device as Class A using official resources.

2. Gather Core Documentation: Begin compiling company constitution, technical staff credentials, and premises-related documents.

3. Initiate Device and Plant Master Files: Refer to our Device Master File guide and Plant Master File guide to prepare these critical documents.

4. Apply for Test License (MD13): Submit your test license application without delay through the CDSCO MD Online Portal.

5. Schedule Product Testing: Contact CDSCO-approved labs early to avoid bottlenecks.

6. Prepare for Audit: Implement or update your ISO 13485 QMS and conduct internal audits.

7. Stay Informed: Regularly check CDSCO notifications and updates on regulatory changes.

By systematically following these steps and leveraging expert guidance, you can confidently secure your MD5 manufacturing license and successfully bring your Stocking, Medical Support device to the Indian market.

For specialized support and end-to-end assistance, feel free to contact us and leverage our 25+ years of regulatory expertise.