CDSCO License for Acupressure calf band
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 wear around the calf to apply pressure to an acupressure point to relieve low back pain, including sciatica and piriformis syndrome. A Non powered belt like device.
Comprehensive Guide to CDSCO Licensing for Acupressure Calf Band (Class A Medical Device)
As regulatory consultants with over 25 years of experience and having supported 500+ companies in securing CDSCO licenses, we understand the importance of precise guidance tailored to your device. This article provides a step-by-step walkthrough for obtaining the mandatory CDSCO manufacturing license (MD5) for the Acupressure Calf Band — a Class A, non-powered rehabilitation device designed to relieve low back pain including sciatica and piriformis syndrome.
Understanding Your Device and Its Regulatory Importance
The Acupressure Calf Band is a low-risk (Class A) medical device intended to apply pressure on acupressure points around the calf to alleviate back pain symptoms. Despite its non-powered nature, regulatory compliance is critical to ensure safety, efficacy, and market acceptance in India. The device falls under the rehabilitation category and is notified under File No. 29/Misc./03/2020-DC (160) dated 04.08.2022, making it subject to CDSCO’s licensing and quality requirements.
CDSCO Regulatory Framework for Class A Medical Devices
The Central Drugs Standard Control Organization (CDSCO) regulates medical devices in India under the Medical Device Rules (MDR) 2017. Class A devices like the Acupressure Calf Band require a manufacturing license issued by the State Licensing Authority through the MD5 license process. This regulatory framework ensures that manufacturers comply with Good Manufacturing Practices (GMP), quality management systems (QMS), and safety standards.
For detailed classification, manufacturers can refer to the Medical Device Classification guide.
Risk Classification and License Requirements for Acupressure Calf Band
- Device Risk Class: A (Low Risk)
- Applicable License: MD5 (Manufacturing License for Class A & B Devices)
- Regulatory Authority: State Licensing Authority
- Notification: File No. 29/Misc./03/2020-DC (160), dated 04.08.2022
Step-by-Step Manufacturing License Process (MD5) for Your Acupressure Calf Band
Obtain Test License (Form MD13): Before manufacturing, apply for a test license which permits production of limited units for testing. This step typically takes 1.5 to 2 months.
Product Testing: Submit your device samples to government-approved testing laboratories to obtain test reports. Refer to the list of testing laboratories.
Document Preparation: Assemble all required documentation including Device Master File, Plant Master File, Risk Management File, Essential Principles Checklist, and QMS documentation.
Submit Manufacturing License Application (Form MD3): File your application for the MD5 license through the CDSCO MD Online Portal.
Audit by Notified Body: A notified body will conduct a GMP audit of your manufacturing facility. You can find the list of notified bodies here.
Resolve Queries: Address any observations or queries raised by the licensing department or notified body promptly.
Grant of License (Form MD5): Upon successful compliance, the State Licensing Authority will issue the MD5 license allowing you to manufacture and market the Acupressure Calf Band in India.
For a detailed overview, our MD5 License Guide offers valuable insights.
Manufacturing License Documents Required
To streamline your application, ensure the following documents are accurate and complete:
- Company Constitution (e.g., Memorandum & Articles of Association)
- Proof of Ownership or Lease of Manufacturing Premises
- Technical Staff Qualifications and Experience
- Fire NOC and Pollution Control Board NOC
- Device Master File (DMF) outlining device design and specifications
- Plant Master File (PMF) detailing manufacturing infrastructure
- Essential Principles Compliance Checklist
- Risk Management File demonstrating hazard analysis and mitigation
- Valid Product Test Reports from approved labs
- Product Labels and Instructions for Use (IFU)
- Quality Management System (QMS) documentation, preferably ISO 13485 compliant
Our comprehensive guides on Device Master Files and Plant Master Files can help in preparing these documents.
Import License Process (MD15) for Acupressure Calf Band
If you plan to import this device, the MD15 license from the Central Licensing Authority is required. The process involves document preparation and submission on the CDSCO portal, followed by query resolution and license issuance. The import license timeline averages 5 to 6 months, with fees based on product class and quantity.
For import-specific procedures, refer to our Import License Guide.
Timeline and Processing Duration
| Step | Duration |
|---|---|
| Test License (MD13) | 1.5 – 2 months |
| Product Testing | 3 – 4 weeks |
| Document Preparation | 2 – 4 weeks |
| MD5 Application Review | 1 – 2 months |
| Audit & Query Resolution | 3 – 4 weeks |
| Total Time | Approx. 3 – 4 months |
Government Fees and Costs
- Test License (MD13): Typically included within the overall process
- MD5 License Application Fee: Rs. 5,000 per application
- Product Fee: Rs. 500 per product
- Additional Costs: Testing fees at government labs (varies by test), notified body audit fees, and professional consultancy fees if applicable
Common Challenges and Practical Solutions
- Delayed Test Reports: Government labs may have backlogs; consider early submission and follow-up.
- Incomplete Documentation: Missing files often cause rejection; use checklists and expert reviews.
- Audit Non-Compliance: Prepare your facility in advance to meet GMP standards; conduct internal audits.
- Query Resolution Delays: Respond promptly with clear evidence to avoid license delays.
Expert Consultation and Support
Navigating CDSCO licensing can be complex, especially for first-time manufacturers. Our deep expertise and hands-on experience allow us to provide tailored support — from document preparation and submission to audit readiness and post-license compliance.
Getting Started with Your CDSCO License Application
- Register your company on the CDSCO MD Online Portal.
- Initiate the test license (MD13) application for your Acupressure Calf Band.
- Engage with notified bodies early to schedule audits.
- Collect and prepare all essential documentation using our detailed guides.
- Maintain proactive communication with CDSCO authorities during the review process.
By following these focused steps and leveraging our expertise, you can efficiently secure your manufacturing license for the Acupressure Calf Band and confidently launch your rehabilitation device in the Indian healthcare market.
