CDSCO License for Core-body mechanical weight 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 enable a patient with a lumbar spine injury to perform controlled extension, contraction, and/or twisting movements of the lumbar/thoracic spine back region and the abdomen, for testing and rehabilitation.
Comprehensive Guide to Obtaining CDSCO License for Core-Body Mechanical Weight Exerciser (Class A Medical Device)
As seasoned regulatory consultants with over 25 years of experience and having assisted 500+ companies in successfully obtaining CDSCO licenses, we understand the nuances and challenges manufacturers and importers face when entering the Indian medical device market. The Core-body mechanical weight exerciser, classified as a Class A medical device under the rehabilitation category, requires compliance with specific regulatory mandates to ensure safe and effective use, especially given its intended application for patients with lumbar spine injuries.
Understanding the Core-Body Mechanical Weight Exerciser and Its Regulatory Importance
This device is designed to enable patients with lumbar spine injuries to perform controlled lumbar and thoracic spine movements, including extension, contraction, and twisting, aiding in testing and rehabilitation. Due to its direct impact on patient safety and therapeutic outcomes, regulatory oversight by CDSCO (Central Drugs Standard Control Organization) is critical.
Securing the appropriate CDSCO license not only ensures compliance with Indian laws but also builds trust with healthcare providers and patients. It facilitates smooth market entry while mitigating risks related to post-market surveillance and regulatory penalties.
CDSCO Regulatory Framework for Class A Medical Devices
The CDSCO categorizes medical devices based on risk into Class A (low risk), B, C, and D. The Core-body mechanical weight exerciser falls under Class A, implying a relatively lower risk profile but still requiring adherence to regulatory controls.
For Class A devices, manufacturing licenses are issued by the State Licensing Authority under the MD5 license (Form MD3 application).
Risk Classification and License Requirements for Core-Body Mechanical Weight Exerciser
- Risk Class: A (Low risk)
- License Type: MD5 Manufacturing License
- Regulatory Authority: State Licensing Authority
- Relevant Notification: File No. 29/Misc./03/2020-DC (160), dated 04.08.2022
Manufacturers must obtain a test license (Form MD13) before applying for the MD5 license. This ensures that the product undergoes mandatory testing at government-approved laboratories.
Step-by-Step Manufacturing License Process (MD5 License for Class A Devices)
Obtain Test License (Form MD13): Apply for a test license on the CDSCO MD Online Portal. This process takes approximately 1.5 to 2 months. The test license allows you to legally manufacture samples for testing.
Product Testing: Get your Core-body mechanical weight exerciser tested at one of the government-approved testing laboratories. Testing typically covers safety, performance, and compliance with essential principles.
Document Preparation: Prepare the required documentation, including Device Master File, Plant Master File, Essential Principles Checklist, Risk Management File, test reports, labeling, and Instructions For Use (IFU).
Application Submission: Submit the manufacturing license application (Form MD3) for the MD5 license on the CDSCO MD Online Portal.
Audit by Notified Body: The State Licensing Authority will coordinate an audit by a notified body to verify compliance with Good Manufacturing Practices (GMP) and QMS.
Query Resolution: Address any queries or clarifications raised by the licensing authority or notified body promptly to avoid delays.
Grant of License: Upon successful audit and document verification, the license is granted on Form MD5, allowing commercial manufacture.
Manufacturing License Documents Required for Core-Body Mechanical Weight Exerciser
- Certificate of Incorporation/Company Constitution
- Proof of ownership/lease of manufacturing premises
- Details and qualifications of technical staff
- Fire NOC and Pollution Control Board NOC
- Detailed Device Master File (DMF) available here
- Plant Master File (PMF) guidance available here
- Essential Principles Compliance Checklist
- Risk Management File (aligned with ISO 14971) - detailed insights at Risk Management
- Product Test Reports from government-approved labs
- Label and Packaging details
- Instructions For Use (IFU) document
- Quality Management System (QMS) documentation (ISO 13485:2016 preferred)
Import License Process (MD15) for Core-Body Mechanical Weight Exerciser
While our primary focus is manufacturing licensing, importers of this device must apply for the MD15 import license from the Central Licensing Authority. This process involves:
- Preparation of documents including manufacturing license, Free Sale Certificate, ISO 13485 certification, CE certificate, Device/Plant Master Files, and wholesale license.
- Submission of application via Form MD14 on the CDSCO MD Online Portal.
- Query resolution and final license issuance on Form MD15.
Import licenses typically take 5-6 months and incur higher fees compared to manufacturing licenses.
Timeline and Processing Duration
| Stage | Duration |
|---|---|
| Test License (Form MD13) | 1.5 - 2 months |
| Product Testing | 1 - 1.5 months |
| Document Preparation | 2 - 3 weeks |
| Application Submission | Immediate upon docs ready |
| Audit & Query Resolution | 1 - 1.5 months |
| Total Time for MD5 License | 3 - 4 months approx |
Government Fees and Costs
- Test License (MD13): Included in the overall process, nominal fee as per CDSCO norms.
- MD5 Manufacturing License: Rs 5,000 per application plus Rs 500 per product.
For a single Core-body mechanical weight exerciser product, expect approximately Rs 5,500 in government fees.
Additional costs include:
- Product testing charges at approved labs
- Fees for notified body audit
- Consultant fees (if outsourced)
Common Challenges and Practical Solutions
Challenge 1: Delays in Test License Issuance
- Solution: Submit complete application with all required documents upfront. Follow up regularly on the CDSCO MD Online Portal.
Challenge 2: Difficulties in Product Testing
- Solution: Engage early with government-approved labs listed here to schedule tests and clarify testing protocols.
Challenge 3: Audit Non-Compliance
- Solution: Conduct internal pre-audit checks against notified body requirements. Maintain complete and updated QMS and plant documentation.
Challenge 4: Query Resolution Delays
- Solution: Designate a responsible team member to promptly respond to regulatory queries with factual, comprehensive replies.
Expert Consultation and Support
Navigating the CDSCO licensing landscape can be complex, especially with the evolving regulatory ecosystem. Our extensive experience in assisting manufacturers and importers of Class A medical devices like the Core-body mechanical weight exerciser ensures:
- Tailored documentation preparation
- Strategic planning for timelines and audit readiness
- Efficient liaison with CDSCO and notified bodies
- Proactive risk management and compliance support
Getting Started with Your CDSCO License Application for Core-Body Mechanical Weight Exerciser
Verify Device Classification: Confirm your device is Class A as per the Medical Device Classification guidelines.
Register on the CDSCO MD Online Portal: Create your account and familiarize yourself with the application process at the CDSCO MD Online Portal.
Prepare Your Test License Application: Gather all preliminary documentation and apply for the test license (MD13).
Plan Product Testing: Contact approved laboratories early to align schedules.
Compile Comprehensive Documentation: Utilize our Device Master File and Plant Master File guides to streamline preparation.
Schedule Notified Body Audit: Identify an appropriate notified body for your audit requirement.
Submit Manufacturing License Application: Once test results and audit outcomes are favorable, apply for the MD5 license.
Maintain Continuous Compliance: Post-license, ensure ongoing adherence to QMS and regulatory updates.
Embarking on your CDSCO licensing journey with a clear roadmap and expert support significantly enhances your chances of timely approval and successful market entry. Reach out to our regulatory consulting team to get personalized assistance tailored to your Core-body mechanical weight exerciser manufacturing or import requirements.
For detailed insights on the MD5 license process, please refer to our comprehensive MD5 License Guide.
Your path to compliant manufacturing and market success starts here.
