CDSCO License for Shoulder continuous passive motion exerciser

Comprehensive Guide to CDSCO Licensing for Shoulder Continuous Passive Motion Exerciser (Class B Device)

Manufacturers and importers of the Shoulder Continuous Passive Motion (CPM) Exerciser—a mains electricity-powered device designed for passive shoulder joint movement during post-surgical or trauma rehabilitation—must navigate India’s regulatory landscape carefully. As a Class B medical device under the Physical Support category, this device requires a CDSCO MD5 manufacturing license or import license to legally enter and operate within the Indian market.

With over 25 years of experience assisting 500+ companies in CDSCO licensing, we provide you with a detailed roadmap covering timelines, fees, documents, and practical insights tailored specifically for this device.

CDSCO Regulatory Framework for Shoulder CPM Exerciser

The Central Drugs Standard Control Organization (CDSCO) governs medical device regulation in India under the Medical Device Rules, 2017. The Shoulder CPM Exerciser, notified under File No. 29/Misc./03/2020-DC (202) dated 26.7.2021, falls under Class B (low moderate risk), requiring compliance with specific licensing processes and quality standards.

Compliance ensures patient safety, market credibility, and legal operation. Both manufacturing and import activities must be licensed through CDSCO’s online portal, streamlining submissions and tracking.

Risk Classification and License Requirements

According to the CDSCO classification, the Shoulder CPM Exerciser is Class B because it is an electrical physical support device that supports therapeutic motion without direct patient control.

• Class B devices require an MD5 manufacturing license (State Licensing Authority) or an MD15 import license (Central Licensing Authority).
• The MD5 license process includes obtaining a test license (MD13), product testing, notified body audit, and final license grant.

For a thorough understanding of device classification, please refer to our resource on Medical Device Classification.

Manufacturing License Process (MD5) for Shoulder CPM Exerciser

For Indian manufacturers, the MD5 license under Form MD3 is mandatory. The process is as follows:

1. Test License (Form MD13): Obtain a test license allowing product testing. Duration: 1.5 to 2 months.
2. Product Testing: Conduct tests at CDSCO-approved laboratories for electrical safety, biocompatibility, and performance. Refer to the Testing Laboratories list.
3. Document Preparation: Compile all required documentation, including Device Master File, Plant Master File, and Risk Management File.
4. Application Submission: Submit Form MD3 via the CDSCO MD Online Portal.
5. Audit: Undergo an audit by a notified body listed here, which assesses compliance to QMS and manufacturing standards.
6. Query Resolution: Address any queries from CDSCO or the notified body promptly.
7. License Grant: Upon satisfactory review, the MD5 license is granted.

Manufacturing License Documents Required

Prepare the following for your Shoulder CPM Exerciser MD5 application:

• Company Constitution Documents: Incorporation certificate, Memorandum & Articles of Association
• Proof of Ownership/Lease of Manufacturing Premises
• Technical Staff Qualification Records: Details of qualified personnel responsible for manufacturing and quality assurance
• Fire and Pollution NOCs from local authorities
• Device Master File (DMF): Detailed device specifications, design, and manufacturing processes. See our Device Master File guide.
• Plant Master File (PMF): Description of manufacturing facility and equipment. Learn how to create one here.
• Essential Principles Checklist: Compliance with Indian medical device essential principles
• Risk Management File: As per ISO 14971 standards. We recommend reviewing our Risk Management guide.
• Test Reports: From CDSCO-approved labs covering electrical safety, mechanical performance, and biocompatibility
• Labels & Instructions for Use (IFU): Compliant with Indian regulations
• Quality Management System (QMS) Documents: ISO 13485:2016 certification and internal SOPs

Import License Process (MD15) for Shoulder CPM Exerciser

Importers must apply for the MD15 license via Form MD14. The process includes:

1. Document Compilation: Manufacturing license of foreign manufacturer, Free Sale Certificate, ISO 13485:2016, CE certificate (if applicable), Device and Plant Master Files
2. Application Submission: Submit via the CDSCO MD Online Portal
3. Review & Queries: CDSCO reviews documents and may raise queries
4. License Grant: Upon compliance, license is issued on Form MD15

Note that no test license is required for imports, but product testing might be requested.

Import License Documents Required

• Valid manufacturing license from the foreign manufacturer
• Free Sale Certificate from the country of origin
• ISO 13485:2016 Quality Management System certificate
• CE Certificate or equivalent (if applicable)
• Device Master File and Plant Master File
• Wholesale license if distributing within India
• Company Constitution documents

Detailed guidance is available in our Import License guide.

Timeline and Processing Duration

For imports, the entire MD15 license process typically takes 5 to 6 months.

Government Fees and Costs

For MD5 Manufacturing License:

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

Additional costs:

• Testing fees at government-approved labs (varies by test scope)
• Notified body audit fees (depend on body and scope)
• Documentation and consultancy fees (if outsourced)

Budgeting realistically for approximately ₹1,00,000 to ₹2,00,000 inclusive of all activities is prudent.

Common Challenges and Solutions

• Delays in Test License Approval: Submit complete and accurate documents during MD13 application to avoid back-and-forth.
• Non-compliance in Audit: Engage experienced notified bodies early and conduct pre-audit internal checks.
• Inadequate Documentation: Use checklists and templates from proven consultants to ensure completeness.
• Query Resolution Delays: Respond promptly with evidence-backed clarifications.

Our extensive experience has helped numerous clients overcome these hurdles efficiently.

Expert Consultation and Support

Navigating CDSCO licensing for Class B devices like the Shoulder CPM Exerciser demands specialized knowledge. Our expert team provides:

• End-to-end license application support
• Customized documentation preparation
• Coordination with notified bodies and testing labs
• Training on regulatory compliance and risk management

Partnering with a seasoned consultancy accelerates approval timelines and reduces compliance risks.

Getting Started with Your CDSCO License Application

1. Assess Your Device Classification: Confirm your device’s risk class and regulatory requirements.
2. Prepare Initial Documents: Gather company constitution, premises proof, and technical staff details.
3. Apply for Test License (MD13): Submit through the CDSCO MD Online Portal to kickstart the process.
4. Arrange for Product Testing: Schedule tests at CDSCO-approved laboratories.
5. Compile Complete Documentation: Use our Device and Plant Master File guides.
6. Engage a Notified Body: Schedule and prepare for the audit.
7. Submit MD5 Application: Apply on the portal and monitor for queries.

Starting early and maintaining strict compliance at each stage is key to timely license grant.

For detailed assistance, explore our comprehensive MD5 License Guide or contact our regulatory experts today.

Entering the Indian medical device market with your Shoulder Continuous Passive Motion Exerciser is achievable with meticulous planning and expert guidance. Our 25+ years of CDSCO licensing experience ensures you stay compliant, competitive, and confident.