CDSCO License for Physical therapy massager

Comprehensive Guide to CDSCO Licensing for Physical Therapy Massagers (Class B Medical Devices)

As a leading regulatory consultancy with over 25 years of experience and having assisted 500+ companies successfully navigate the CDSCO licensing process, we understand the unique challenges manufacturers and importers face with medical devices like the Physical Therapy Massager. This electrically powered device used for therapeutic massage falls under the Rehabilitation category and is classified as a Class B risk device according to the Indian medical device regulatory framework.

The notification for this device is filed under No. 29/Misc./03/2020-DC (160), dated 04.08.2022, confirming its classification and regulatory pathway. Below is a detailed walkthrough designed to help you efficiently obtain your CDSCO manufacturing or import license.

CDSCO Regulatory Framework for Physical Therapy Massagers

The Central Drugs Standard Control Organization (CDSCO) governs medical device regulation in India. As per the Medical Device Rules, 2017, devices are categorized and risk-classified to ensure patient safety and product efficacy. The Physical Therapy Massager is classified as a Class B device, which denotes low to moderate risk.

Class B devices require compliance with specific quality systems and testing, including adherence to essential principles of safety and performance, making regulatory approval both rigorous and manageable.

Risk Classification and License Requirements for Physical Therapy Massagers

• Device Name: Physical Therapy Massager
• Risk Class: B
• Category: Rehabilitation
• Regulatory License Required: Manufacturing License MD5

Class B devices such as this require a manufacturing license under Form MD3 (MD5 License), overseen by the State Licensing Authority.

Manufacturing License Process (MD5) for Physical Therapy Massagers

The MD5 licensing pathway involves several critical stages:

1. Test License Application (Form MD13): Before full manufacturing license approval, you must apply for a test license to produce and test products. This generally takes 1.5 to 2 months.

2. Product Testing: Conduct product testing at government-approved laboratories to verify compliance with standards. Testing duration depends on lab availability and sample complexity.

3. Documentation Preparation: Assemble comprehensive documentation including Device Master File (DMF), Plant Master File (PMF), Risk Management File, Essential Principles Checklist, and Quality Management System (QMS) documents.

4. Application for Manufacturing License (Form MD3): Submit the application via the CDSCO MD Online Portal with all required documents.

5. Audit by Notified Body: A notified body will perform an audit of your manufacturing facility and QMS. You can find the list of notified bodies here.

6. Resolution of Queries: Address any queries from the licensing authority or notified body promptly.

7. Grant of License (Form MD5): Upon successful audit and documentation verification, the manufacturing license is granted.

The entire process typically takes 3 to 4 months.

Manufacturing License Documents Required for Physical Therapy Massagers

To ensure smooth processing, prepare the following documents meticulously:

• Company Constitution (e.g., Certificate of Incorporation)
• Proof of Ownership or Lease of Manufacturing Premises
• Details and Qualifications of Technical Staff
• Fire No Objection Certificate (NOC)
• Pollution Control Board NOC
• Device Master File (DMF) detailing device specifications and manufacturing processes (Learn more about DMFs)
• Plant Master File (PMF) describing manufacturing site and quality controls (PMF Guide)
• Essential Principles Checklist
• Risk Management File demonstrating hazard analysis and mitigation (Risk Management Insights)
• Test Reports from government-approved testing laboratories (Testing Laboratories List)
• Labels and Instructions for Use (IFU)
• Quality Management System Documents (ISO 13485:2016 compliance)

Attention to detail in document preparation can significantly reduce processing delays.

Import License Process (MD15) for Physical Therapy Massagers

For importers, the MD15 license is mandatory and granted by the Central Licensing Authority. The process includes:

• Preparation of required documentation (including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485 certificate, CE certificate if applicable, DMF, PMF, and Wholesale License)
• Application submission on the CDSCO MD Online Portal
• Resolution of any queries raised
• License grant within approximately 5 to 6 months

Unlike the MD5 process, no test license is required for import licensing.

Import License Documents Required

• Valid Manufacturing License from the Country of Origin
• Free Sale Certificate
• ISO 13485:2016 Certification
• CE Certificate (if applicable)
• Device Master File (DMF)
• Plant Master File (PMF)
• Wholesale License
• Company Constitution Documents

Timeline and Processing Duration

Note: Timelines may vary based on the completeness of documentation and responsiveness to queries.

Government Fees and Costs

For Physical Therapy Massagers (Class B), the fee structure is as follows:

• MD5 License:

  • Application Fee: Rs. 5,000
  • Per Product Fee: Rs. 500

• MD15 Import License:

  • Site Fee: $2,000
  • Per Product Fee: $1,000

Budgeting for these fees upfront aids in smooth financial planning.

Common Challenges and Practical Solutions

• Incomplete Documentation: Ensuring that Device Master File and Plant Master File are comprehensive reduces back-and-forth with regulators.
• Delayed Testing: Engage early with approved government labs to schedule testing and avoid bottlenecks.
• Audit Non-Compliance: Pre-audit assessments by experienced consultants can uncover gaps.
• Query Resolution Delays: Designate a point person to promptly handle regulatory queries.

Expert Consultation and Support

With our extensive regulatory experience, we offer tailored support including:

• Gap analysis of your technical and quality documentation
• Assistance in preparing and reviewing DMF and PMF
• Coordination with notified bodies for timely audits
• End-to-end application filing and follow-up through the CDSCO MD Online Portal

Our proven track record ensures faster approvals and regulatory compliance.

Getting Started with Your CDSCO License Application for Physical Therapy Massagers

1. Classify Your Device: Confirm your device is Class B as per the notification dated 04.08.2022.
2. Prepare Documentation: Begin compiling all required files, focusing on quality and completeness.
3. Apply for Test License: Submit Form MD13 to initiate the test manufacturing phase.
4. Schedule Testing: Engage with approved labs early to arrange product testing.
5. Plan for Audit: Choose a notified body from the official list and prepare your facility.
6. Submit License Application: Complete and submit Form MD3 for the MD5 license via the CDSCO portal.
7. Manage Queries and Compliance: Respond swiftly to any regulatory observations.

Embarking on this structured approach will streamline your pathway to market entry for your Physical Therapy Massager in India.

For personalized assistance and to avoid common pitfalls, connect with our expert team to guide you through every stage of the CDSCO licensing process.