CDSCO License for Assistive ergonomic chair mobility base

Introduction to Assistive Ergonomic Chair Mobility Base and Regulatory Importance

The Assistive Ergonomic Chair Mobility Base is a vital pediatric healthcare device designed to enhance mobility support for disabled patients, particularly children. This manually-operated, height-adjustable, non-powered device provides a safe and ergonomic way for healthcare providers or carers to assist patient mobility. Because it directly impacts patient safety and care quality, regulatory compliance with the Central Drugs Standard Control Organization (CDSCO) is mandatory before marketing in India.

Navigating the CDSCO licensing framework can be complex, but with over 25 years of experience and having assisted 500+ companies, we provide you with detailed, actionable guidance to secure your Class A medical device license efficiently.

CDSCO Regulatory Framework for Assistive Ergonomic Chair Mobility Base

The regulatory oversight of medical devices in India falls under the Medical Device Rules (MDR) 2017, governed by CDSCO. Our device, the Assistive Ergonomic Chair Mobility Base, falls under the pediatric and neonatology category and is classified as a Class A device - the lowest risk classification. Such devices require a manufacturing license (MD5) issued by the State Licensing Authority.

Given the device’s critical role, adherence to safety, quality, and performance standards is non-negotiable. This includes compliance with essential principles, risk management, and quality management system implementation.

Risk Classification and License Requirements for Class A Devices

According to CDSCO’s classification:

• Class A (Low Risk): Includes non-invasive devices like our mobility base.
• License Type: MD5 Manufacturing License (Form MD3 for application).
• Issued by: State Licensing Authority.
• Process duration: Approximately 3-4 months.

Class A devices require a test license (MD13), product testing, audits by notified bodies, and submission of comprehensive documentation. This ensures the device's safety for vulnerable pediatric patients.

Manufacturing License Process (MD5) for Assistive Ergonomic Chair Mobility Base

The MD5 license process involves the following key stages:

1. Test License Application (Form MD13): Apply for a test license to legally produce and test prototype devices. This phase takes 1.5-2 months.
2. Product Testing: Conduct product testing at CDSCO-approved government laboratories to verify compliance with safety and performance standards. Refer to the list of testing laboratories.
3. Documentation Preparation: Compile required documents such as Device Master File, Plant Master File, Risk Management File, and others.
4. Application Submission (Form MD3): Submit your manufacturing license application through the CDSCO MD Online Portal.
5. Audit by Notified Body: The notified body conducts an on-site audit to verify compliance. Check the list of notified bodies for authorized auditors.
6. Resolution of Queries: Address any queries or deficiencies raised by CDSCO or the notified body.
7. Issuance of MD5 License: Upon satisfactory review, the license is granted on Form MD5.

Manufacturing License Documents Required

For the Assistive Ergonomic Chair Mobility Base (Class A), prepare the following documents:

• Company Constitution documents (e.g., incorporation certificate)
• Proof of ownership or lease agreement of manufacturing premises
• Technical personnel qualifications and experience certificates
• Fire and Pollution No Objection Certificates (NOCs)
• Device Master File detailing design, specifications, and manufacturing process (DMF Guide)
• Plant Master File outlining manufacturing facility and equipment (Plant Master File Guide)
• Essential Principles Checklist demonstrating compliance with CDSCO standards
• Risk Management File documenting hazard analysis and mitigation (Risk Management)
• Test reports from government-approved labs
• Labels and Instructions for Use (IFU) complying with labeling requirements
• Quality Management System (QMS) documents such as ISO 13485 certification

Import License Process (MD15) for Assistive Ergonomic Chair Mobility Base

If you intend to import this device into India, an MD15 import license is mandatory. The process is centralized at CDSCO and includes:

1. Document Preparation: Gather import-specific documents, including a valid manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016 certification, CE marking if applicable, and Device/Plant Master Files.
2. Application Submission (Form MD14): Submit your import license application via the CDSCO MD Online Portal.
3. Query Resolution: Address any information requests from CDSCO.
4. License Issuance (Form MD15): After review, CDSCO grants the import license.

For Class A devices, the import license process typically takes 5-6 months.

Import License Documents Required

Key documents for MD15 include:

• Valid manufacturing license from the exporting country
• Free Sale Certificate from the country of origin
• ISO 13485:2016 Quality Management System certificate
• CE Certificate (if applicable)
• Device Master File and Plant Master File
• Wholesale License for distribution in India
• Company Constitution certificates

Timeline and Processing Duration

For import license (MD15), the process may extend to 5-6 months, accounting for additional document verification.

Government Fees and Costs

• MD5 License (Class A):

  • Application fee: INR 5,000
  • Per product fee: INR 500

• MD15 Import License (Class A):

  • Site fee: USD 1,000 (~INR 75,000)
  • Per product fee: USD 50 (~INR 3,750)

Additional costs include notified body audit fees, product testing charges at government labs, and consultancy fees if applicable.

Common Challenges and Solutions

Challenge 1: Delays in product testing due to laboratory backlogs.

• Solution: Schedule testing in advance and select government labs with shorter lead times using the Testing Laboratories list.

Challenge 2: Incomplete or non-compliant documentation.

• Solution: Use comprehensive checklists for Device Master File, Plant Master File, and Risk Management. Our detailed guides can streamline this process.

Challenge 3: Audit non-conformities leading to repeated inspections.

• Solution: Pre-audit internal checks and engaging experienced notified bodies listed on the CDSCO portal ensure preparedness.

Challenge 4: Managing timelines with multiple concurrent steps.

• Solution: Plan your application roadmap with buffer periods and maintain proactive communication with CDSCO and notified bodies.

Expert Consultation and Support

With two and a half decades of regulatory expertise, we have enabled over 500 medical device companies to seamlessly obtain CDSCO licenses. Our support includes:

• Tailored documentation preparation tailored to your device’s unique specifications
• Coordination with notified bodies and government labs
• Timely follow-up for query resolution
• Compliance audits and gap analysis pre-submission

For the Assistive Ergonomic Chair Mobility Base, our industry-specific knowledge ensures you meet pediatric device safety standards effectively.

Getting Started with Your CDSCO License Application

To initiate your journey toward CDSCO MD5 licensing for the Assistive Ergonomic Chair Mobility Base, follow these practical steps:

1. Register on the CDSCO MD Online Portal
   • Visit the CDSCO MD Online Portal and create a user account.
2. Prepare Initial Documentation
   • Gather constitution documents, proof of premises, and technical staff credentials.
3. Apply for Test License (Form MD13)
   • Submit your application to legally produce prototypes for testing.
4. Plan Product Testing
   • Choose an approved government lab early to schedule product testing.
5. Develop Comprehensive Files
   • Prepare your Device Master File, Plant Master File, Risk Management File, and QMS documents.
6. Identify a Notified Body
   • Select a notified body from the CDSCO Notified Bodies list to conduct the required audit.
7. Submit Manufacturing License Application (Form MD3)
   • After successful testing, apply for the MD5 license.

Taking these steps promptly will place you on a structured path toward regulatory approval, enabling access to the rapidly growing Indian pediatric medical device market.

For personalized assistance and end-to-end support, connect with our expert team today and leverage our 25+ years of regulatory proficiency to accelerate your CDSCO licensing journey.