CDSCO License for Parallel bar exerciser,
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).
Intended Use
Intended to assist users in maintaining good walking posture, particularly a person with a disability, a paraplegic, or a patient who has suffered a stroke and is learning to walk.
Introduction to Parallel Bar Exerciser and Its Regulatory Importance
The Parallel Bar Exerciser is a vital rehabilitation medical device designed to assist individuals—such as those with disabilities, paraplegics, or stroke patients—in regaining and maintaining proper walking posture. Given its critical role in patient mobility and safety, compliance with CDSCO regulations is paramount to ensure the device meets quality and safety standards before entering the Indian market.
With over 25 years of experience helping more than 500 companies navigate the complex regulatory landscape, we understand the nuances involved in securing the appropriate CDSCO license for such Class A medical devices. This guide details the entire process, from risk classification to license acquisition, tailored specifically for Parallel Bar Exercisers.
CDSCO Regulatory Framework for Rehabilitation Devices like Parallel Bar Exerciser
In India, the Central Drugs Standard Control Organization (CDSCO) governs the regulation of medical devices under the Medical Device Rules (MDR) 2017. Rehabilitation devices fall under this framework and must adhere to rigorous standards to ensure user safety and efficacy.
The Parallel Bar Exerciser, as a rehabilitation device, is notified under File No. 29/Misc./03/2020-DC (160) dated 04.08.2022, which aligns it with current CDSCO classifications and mandates compliance with prescribed licensing procedures.
Risk Classification and License Requirements for Parallel Bar Exerciser
Medical devices in India are categorized into four risk classes: A, B, C, and D, based on potential risk to users. The Parallel Bar Exerciser is classified as a Class A device, indicating low risk.
For Class A devices, the applicable manufacturing license is the MD5 license, issued by the respective State Licensing Authority. Importers must obtain the MD15 import license from the Central Licensing Authority.
Understanding this classification is critical because it determines the specific forms, fees, testing, and audit requirements necessary for compliance. For more on medical device classification, you can refer to our detailed Medical Device Classification guide.
Manufacturing License Process (MD5) for Parallel Bar Exerciser
Step 1: Obtain Test License (Form MD13)
Before applying for the MD5 manufacturing license, manufacturers must secure a test license (MD13) to conduct product testing. This typically takes about 1.5 to 2 months.
Step 2: Product Testing
The device must be tested at CDSCO-approved government laboratories to validate compliance with applicable standards. Refer to the official Testing Laboratories list for authorized labs.
Step 3: Document Preparation
Prepare comprehensive documentation including Device Master File, Plant Master File, Essential Principles Checklist, Risk Management File, Test Reports, Labels, Instructions for Use (IFU), and Quality Management System (QMS) documents.
Step 4: Submit Application (Form MD3)
Application for the MD5 license is filed through the CDSCO MD Online Portal, using Form MD3.
Step 5: Audit by Notified Body
A notified body must audit the manufacturing site to verify compliance. Check the list of notified bodies for authorized auditors.
Step 6: Resolve Queries
Respond promptly to any queries raised by the licensing authority or notified body to avoid delays.
Step 7: License Grant (Form MD5)
Upon satisfactory review, the MD5 license is granted, allowing legal manufacturing of the Parallel Bar Exerciser in India.
Manufacturing License Documents Required
For the Parallel Bar Exerciser MD5 license application, the following documents are essential:
- Company Constitution/Certificate of Incorporation
- Proof of Ownership or Lease Agreement of Manufacturing Premises
- Qualification Documents of Technical Staff
- Fire NOC and Pollution Control Board Clearance
- Device Master File (DMF) detailing device specifications and design (Guide to Device Master File)
- Plant Master File (PMF) outlining manufacturing processes (Plant Master File Guide)
- Essential Principles Checklist confirming compliance with regulatory standards
- Risk Management File demonstrating hazard analysis and mitigation strategies (Risk Management Insights)
- Test Reports from CDSCO-approved labs
- Product Labels and Instructions for Use (IFU)
- Quality Management System (QMS) documentation, typically ISO 13485:2016 certification
Ensuring thorough and accurate documentation significantly reduces processing delays.
Import License Process (MD15) for Parallel Bar Exerciser
Manufacturers or importers intending to bring the Parallel Bar Exerciser into India must obtain an MD15 import license issued by the Central Licensing Authority.
Key Steps:
- Prepare required documents including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016 certificate, CE Certificate (if applicable), Device and Plant Master Files, Wholesale License, and Company Constitution.
- Submit the application using Form MD14 on the CDSCO MD Online Portal.
- Address any queries raised by CDSCO promptly.
- Await license issuance, which typically takes 5 to 6 months.
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
- Plant Master File
- Wholesale License
- Company Constitution/Certificate of Incorporation
Timeline and Processing Duration
| License Type | Duration | Notes |
|---|---|---|
| Test License (MD13) | 1.5 – 2 months | Mandatory before manufacturing license |
| MD5 Manufacturing License | 3 – 4 months | Includes audit and query resolution |
| MD15 Import License | 5 – 6 months | No test license required |
Plan your project timelines accordingly to accommodate these regulatory requirements.
Government Fees and Costs
For the Parallel Bar Exerciser (Class A device), the fee structure for manufacturing license (MD5) is:
- Application Fee: Rs 5,000 per application
- Product Fee: Rs 500 per product
For importing the same device under an MD15 license, fees are:
- Site Fee: Approximately $1,000 per site
- Product Fee: Approximately $50 per product
These fees are payable online via the CDSCO portal during application submission.
Common Challenges and Solutions
Delayed Product Testing: Testing turnaround times can be lengthy. To mitigate delays, schedule tests early and choose labs from the CDSCO-approved Testing Laboratories list.
Incomplete Documentation: Missing or inconsistent documents are a frequent cause of rejection. Utilize detailed checklists and consult experts to prepare flawless submissions.
Audit Non-Compliance: Site audits can identify gaps in QMS or facility standards. Conduct internal audits and pre-assessment reviews before notified body visits.
Query Resolution Delays: Prompt and clear responses to CDSCO queries are essential. Assign dedicated regulatory personnel to monitor and address communications swiftly.
Expert Consultation and Support
Our team, with over 25 years of regulatory consultancy experience, has successfully guided 500+ companies through the CDSCO licensing maze. We offer:
- Customized document preparation including DMF and PMF
- Scheduling and facilitation of product testing
- Pre-audit compliance checks and training
- End-to-end license application management
Partnering with experienced consultants can significantly shorten approval times and reduce risk of non-compliance.
Getting Started with Your CDSCO License Application for Parallel Bar Exerciser
- Assess your product classification: Confirm the device’s risk class and applicable licensing paths.
- Prepare your facility: Ensure your manufacturing site and QMS comply with CDSCO and ISO standards.
- Gather essential documents: Utilize our guides on Device Master Files and Plant Master Files.
- Apply for Test License (MD13): Submit through the CDSCO MD Online Portal.
- Coordinate product testing: Engage CDSCO-approved labs early.
- Submit MD5 License Application (Form MD3): After successful testing, proceed with the manufacturing license application.
- Prepare for audit: Arrange for notified body audit as per guideline.
- Track and respond: Monitor application status and respond to queries promptly.
Starting early and leveraging expert support can make the licensing process for your Parallel Bar Exerciser smooth and efficient, enabling timely market access in India.
For tailored assistance, feel free to reach out to our regulatory experts who specialize in rehabilitation devices and CDSCO licensing.
