CDSCO License for Inversion table

Comprehensive Guide to CDSCO Licensing for Inversion Tables (Class A Medical Device)

Inversion tables are gaining popularity as non-invasive devices designed to alleviate back pain by allowing patients to invert their bodies safely. Classified as Class A medical devices under Indian regulations, these fixed framework devices require proper licensing from the Central Drugs Standard Control Organization (CDSCO) before manufacturing or importing in India. With over 25 years of regulatory consulting experience and 500+ successful CDSCO approvals, we provide you with an expert, step-by-step roadmap to secure your manufacturing or import license for inversion tables.

CDSCO Regulatory Framework for Inversion Tables

Inversion tables fall under the Pain Management category and are notified under File No. 29/Misc./03/2020-DC (178), dated 13.9.2021. As a Class A device, the regulatory framework mandates compliance with the Medical Device Rules, 2017, including obtaining a manufacturing license (MD5) if you produce locally or an import license (MD15) if you bring the device into India.

The CDSCO governs device registration and licensing, ensuring safety, efficacy, and quality standards are met. This framework requires manufacturers to demonstrate compliance with technical documentation, quality management systems, and testing protocols.

Risk Classification and License Requirements for Inversion Tables

Your inversion table is classified as a Class A medical device, which is considered low risk. The licensing process for Class A devices involves:

• Obtaining a Test License (MD13) initially for product testing,
• Completing product testing through government-approved laboratories,
• Preparing detailed technical and quality documents,
• Applying for a Manufacturing License (MD5) via state regulatory authorities.

For Class A devices like inversion tables, the MD5 license is mandatory for manufacturing, while importers require an MD15 license granted by the central authority.

Manufacturing License Process (MD5) for Inversion Tables

The MD5 license process is detailed yet streamlined for Class A devices. Here’s the typical journey:

1. Apply for Test License (Form MD13): Allows initial testing of your inversion table. This takes approximately 1.5 to 2 months.
2. Conduct Product Testing: Get your device tested at CDSCO-approved labs to verify compliance with relevant standards. Testing duration varies but usually completes within 1 month.
3. Prepare Documentation: Compile all required documents (see next section). Accuracy at this stage reduces delays.
4. Submit MD5 Application (Form MD3): Apply through the CDSCO MD Online Portal.
5. Audit by Notified Body: A mandatory audit by a notified body verifies your quality management system and manufacturing process. Find your audit body on the Notified Bodies List.
6. Resolve Queries: Address any observations or queries raised during audit or review.
7. License Grant: Upon satisfactory compliance, the license is granted on Form MD5.

Total timeline: Approximately 3 to 4 months from test license application to final license grant.

Manufacturing License Documents Required for Inversion Tables

To ensure a smooth application, prepare the following mandatory documents:

• Company Constitution: Certificate of incorporation, partnership deed, or other legal documents.
• Proof of Ownership or Lease of Premises: Rent agreement or sale deed.
• Technical Staff Details: Qualifications and experience certificates of manufacturing and quality personnel.
• Fire NOC and Pollution Control NOC: From local authorities.
• Device Master File (DMF): Detailed technical specifications and manufacturing process documentation. Our comprehensive Device Master File guide can assist.
• Plant Master File (PMF): Manufacturing site details, equipment, and facility layout. Use this Plant Master File Guide for preparation.
• Essential Principles Checklist: Compliance with safety and performance standards.
• Risk Management File: Documentation of risk analysis specific to inversion table use. Learn more about Risk Management.
• Test Reports: From CDSCO-approved testing laboratories. Refer to the Testing Laboratories list.
• Labels and Instructions for Use (IFU): Clear and compliant labeling.
• Quality Management System (QMS) Documents: ISO 13485 certification and internal SOPs.

Careful preparation of these documents significantly reduces back-and-forth during review.

Import License Process (MD15) for Inversion Tables

If you plan to import inversion tables into India, the MD15 license is required. This license is issued by the central licensing authority and involves:

• Compiling import-specific documentation,
• Applying on the CDSCO MD Online Portal,
• Responding to departmental queries,
• Final grant of license (Form MD15).

Unlike MD5, no test license is required before application, but robust technical documents and certifications are essential.

Import License Documents Required

Key documents for MD15 import license include:

• Valid Manufacturing License: From the country of origin.
• Free Sale Certificate: Ensuring the device is sold freely in the country of origin.
• ISO 13485:2016 Certificate: Demonstrating quality management compliance.
• CE Certificate: If applicable, showing conformity with European standards.
• Device and Plant Master Files: Detailed technical and manufacturing information.
• Wholesale License: For storage and distribution in India.
• Company Constitution and Address Proof: For the Indian importer.

Government fees depend on the device class and number of products.

Timeline and Processing Duration

Being proactive in document readiness can help avoid unnecessary delays.

Government Fees and Costs

For your Class A inversion table manufacturing license (MD5):

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

Testing and notified body audit costs are additional and vary by provider. For imports (MD15), fees differ by class and product quantity, generally ranging from $1000 to$3000 per site plus per product fees.

Common Challenges and Solutions

• Incomplete Documentation: Missing or inconsistent documents lead to delays. Solution: Use checklists and expert review before submission.
• Delayed Test Reports: Selecting non-approved labs causes rejections. Solution: Always opt for labs from the official Testing Laboratories list.
• Audit Non-Compliance: Poor facility readiness leads to negative audit outcomes. Solution: Prepare your QMS and manufacturing site per notified body guidelines.
• Query Resolution Delays: Slow responses prolong licensing. Solution: Assign a dedicated team member to promptly handle CDSCO communications.

Expert Consultation and Support

With decades of experience and over 500 successful CDSCO license approvals, we assist manufacturers and importers at every step—from documentation to audit preparation and query resolution. Our tailored approach minimizes risk and accelerates approval timelines.

Getting Started with Your CDSCO License Application

1. Assess your device classification and intended use to confirm Class A status.
2. Prepare essential documents—start with your Device Master File and Plant Master File.
3. Apply for your Test License (MD13) on the CDSCO MD Online Portal to initiate product testing.
4. Engage with notified bodies early to schedule your audit.
5. Plan your budget and timelines realistically, factoring in government fees and external service costs.
6. Consider expert regulatory consulting to guide you through complex steps and ensure compliance.

Embarking on your CDSCO licensing journey with a clear roadmap and expert support will position your inversion table effectively in the growing Indian medical device market.

For more detailed insights and personalized assistance, connect with our regulatory experts today.