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CDSCO License for Massage table/couch

Medical Device Information

Important Notice for Class A Devices

Class A Non-sterile Non Measuring devices are exempt from MD5 and MD15 licenses. Only CDSCO registration is required as per GSR 777(E).

Device Class
Class A

Intended Use

A table designed for various kinds of complementary therapy.

Manufacturing License
MD5
Import License
MD15
CDSCO License for Massage table/couch

Introduction to Massage Table Regulatory Compliance in India

Massage tables or couches serve as essential equipment in complementary therapies, particularly within the pain management category. Designed to facilitate various therapeutic procedures, these devices fall under Class A medical devices as per CDSCO classification, indicating low risk. Navigating the regulatory landscape in India is critical for manufacturers and importers to ensure market access and compliance.

With over 25 years of regulatory consulting experience and having assisted 500+ companies in obtaining their CDSCO licenses, we provide comprehensive insights tailored for manufacturers of massage tables. Understanding the specific regulatory framework, timelines, costs, and documentation requirements will streamline your market entry strategy.

CDSCO Regulatory Framework for Massage Tables (Class A Medical Devices)

The Central Drugs Standard Control Organization (CDSCO) regulates medical devices under the Medical Device Rules, 2017. Massage tables, classified as Class A devices due to their low-risk profile, require a manufacturing license (MD5) granted by the State Licensing Authority. Importers must obtain an import license (MD15) from the Central Licensing Authority.

The device notification for massage tables is documented under File No. 29/Misc./03/2020-DC (178), dated 13.9.2021, confirming its classification and regulatory applicability.

Risk Classification and License Requirements for Massage Tables

Massage tables are designated as Class A devices — the lowest risk category in CDSCO’s classification system. Class A devices require a manufacturing license known as MD5 (application via Form MD3) issued by the State Authority.

  • Manufacturing License: MD5 (State Authority)
  • Import License: MD15 (Central Authority)

This risk classification influences the regulatory pathway, fees, documentation, and inspection requirements. For a detailed overview, you can review the Medical Device Classification guide.

Manufacturing License Process for Massage Tables (MD5 License)

The MD5 license process involves several sequential steps designed to verify product safety, manufacturing practices, and compliance with quality standards. Here's a practical, step-by-step outline:

  1. Test License Application (Form MD13): Initially, apply for a test license to manufacture the massage table prototypes for testing. This takes approximately 1.5 to 2 months.
  2. Product Testing: Get the massage tables tested at CDSCO-recognized laboratories. Use the list of testing laboratories to select an approved lab.
  3. Document Preparation: Compile essential documents including Device Master File, Plant Master File, risk management files, and QMS records.
  4. Application Submission: Submit the manufacturing license application on Form MD3 via the CDSCO MD Online Portal.
  5. Audit by Notified Body: Undergo an audit conducted by notified bodies listed on the Notified Bodies List for MD5 Audit.
  6. Queries Resolution: Address any queries raised by the CDSCO department or notified body.
  7. License Grant (Form MD5): Upon satisfactory review and audit, the manufacturing license will be granted.

The entire process from test license application to final license issuance generally takes 3 to 4 months.

Manufacturing License Documents Required for Massage Tables

For a smooth application process, ensure submission of the following comprehensive documentation:

  • Company Constitution (Incorporation Certificate, Memorandum & Articles of Association)
  • Proof of Ownership or Lease Agreement of Manufacturing Premises
  • Qualification and Experience Documents of Technical Staff
  • Fire NOC and Pollution Control Certification
  • Device Master File (DMF) detailing design, specifications, and manufacturing processes (Device Master File Guide)
  • Plant Master File (PMF) describing the manufacturing facility (Plant Master File Guide)
  • Essential Principles Checklist confirming compliance with Indian medical device standards
  • Risk Management File demonstrating hazard identification and mitigation (Risk Management)
  • Test Reports from government-approved laboratories
  • Labels and Instructions for Use (IFU) with clear, compliant information
  • Quality Management System (QMS) documentation, preferably ISO 13485:2016 certified

Meticulous preparation of these documents significantly reduces back-and-forth queries and accelerates approval.

Import License Process for Massage Tables (MD15 License)

If you are importing massage tables into India, you must obtain an MD15 import license from the Central Licensing Authority. The process includes:

  1. Document Compilation: Prepare all requisite documents such as manufacturing license from the country of origin, Free Sale Certificate, CE certificate, ISO 13485 certification, Device and Plant Master Files, wholesale license, and company constitution.
  2. Application Submission: File the application using Form MD14 on the CDSCO MD Online Portal.
  3. Queries Resolution: Respond promptly to queries from the CDSCO.
  4. License Grant: Upon satisfactory review, the MD15 license is issued.

The import licensing process typically takes 5 to 6 months. Unlike manufacturing licenses, no test license is required upfront.

Import License Documents Required

Key documents include:

  • Valid Manufacturing License from the country of origin
  • Free Sale Certificate (FSC) proving product marketing approval abroad
  • ISO 13485:2016 Certificate
  • CE Certification (if applicable)
  • Device Master File
  • Plant Master File
  • Wholesale License for distribution
  • Company Constitution documents

Ensuring all documents are authentic, current, and properly translated (if required) expedites review.

Timeline and Processing Duration

License TypeApproximate Duration
Test License (MD13)1.5 to 2 months
Manufacturing License (MD5)3 to 4 months (including test license, testing, audit)
Import License (MD15)5 to 6 months

Planning your regulatory timeline with these durations in mind helps optimize product launch schedules.

Government Fees and Costs for Massage Tables

For Class A devices such as massage tables, the fee structure is as follows:

  • MD5 Manufacturing License: Rs. 5,000 per application + Rs. 500 per product
  • Test License (MD13): Included in the process, standard fees apply
  • Import License (MD15): 1,000persite+1,000 per site + 50 per product

Additional costs may include fees for notified body audits, product testing, and consultancy services.

Common Challenges and Solutions

  • Delayed Testing Results: Opt for government-approved labs with lower backlog; schedule tests early.
  • Incomplete Documentation: Use checklists and expert review to avoid missing critical documents like Device Master Files.
  • Audit Non-compliance: Prepare your manufacturing facility per notified body guidelines; conduct mock audits.
  • Query Response Delays: Assign dedicated regulatory personnel to track and respond to CDSCO queries promptly.

Our extensive experience shows proactive planning and thorough documentation are key to overcoming these challenges.

Expert Consultation and Support

Navigating CDSCO regulations for massage tables can be complex, especially for first-time applicants. We offer end-to-end consultancy services including:

  • Gap analysis of existing documentation
  • Preparation of Device and Plant Master Files
  • Coordination with notified bodies and testing labs
  • Application drafting and submission on the CDSCO MD Online Portal
  • Post-license compliance support

Our team has successfully guided 500+ manufacturers through this process, ensuring timely approvals and regulatory compliance.

Getting Started with Your CDSCO License Application for Massage Tables

Ready to enter the Indian market with your massage table? Here’s a practical checklist to kickstart the CDSCO licensing process:

  1. Verify Device Classification: Confirm your device is Class A under the CDSCO notification.
  2. Register on CDSCO MD Online Portal: Create an account to access application forms and track submissions.
  3. Prepare Test License Application (MD13): Compile prototype samples and initial documentation.
  4. Select Approved Testing Laboratory: Schedule product testing early to avoid delays.
  5. Develop Key Documentation: Device Master File, Plant Master File, Risk Management, and QMS documents.
  6. Identify Notified Body for Audit: Choose from the Notified Bodies List to plan your audit.
  7. Submit Manufacturing License Application (MD3): After test license and testing completion.
  8. Respond to Queries Promptly: Allocate resources to handle CDSCO and audit body communications.

By following these steps and leveraging expert support, your massage table manufacturing license application can proceed efficiently and effectively.

For detailed guidance, explore our comprehensive MD5 License Guide and reach out to our consultants who specialize in Indian medical device regulatory affairs.

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About the Author

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Tails Azimuth
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