Do you know CDSCO registration for wheelchairs is a legal requirement in India that applies to all types of wheelchairs, even if manual, powered, or custom-built. Governed by the Central Drugs Standard Control Organization (CDSCO) under the Medical Device Rules, 207. This registration makes sure that all wheelchairs sold, imported. Or manufactured in India, complies with approved safety, quality, and performance standards. Whether you are an importer, local manufacturer, brand owner, or distributor, completing the CDSCO registration helps you to stay compliant. In this article, you will learn about the procedure, documentation, and much more.
Understand CDSCO Registration for Wheelchairs
CDSCO registration for wheelchairs refers to the approval process regulated by the CDSCO for entities involved in the manufacturing, importing, or distributing wheelchairs in India. This process ensures that every wheelchair satisfies the quality and safety requirements specified in the 2017 Medical Device Rules. Wheelchairs, being important mobility aids, are categorized under medical devices because of their significant role in patient care. As part of the registration process, the product’s design, manufacturing method, and quality control procedures are all detailed and submitted to the CDSCO for review and approval.
Why is CDSCO registration Mandatory For Wheelchairs in India?
CDSCO registration for wheelchairs is necessary in India to guarantee that all wheelchairs available in the market are safe, effective, and of high quality. The primary reason for this mandatory registration includes:
User Safety – Wheelchairs are utilized by individuals with mobility challenges, and malfunctions can lead to serious injuries.
Regulatory Compliance – As per the Medical Device Rules, 2017, all medical devices, including wheelchairs, should be registered with the CDSCO before being sold in India.
Quality Assurance – By ensuring that producers adhere to defined quality control procedures, registration preserves the dependability of the product.
Market Authorization – Wheelchair importers and manufacturers cannot lawfully market or sell wheelchairs in India without CDSCO registration.
Classification of Wheelchairs Under CDSCO Medical Device Rules
Under the Medical Device Rules, 2017, wheelchairs are classified based on their intended use and associated risk levels.
- Class A – Manual wheelchairs without electronic components.
- Class B – Powered or electronic wheelchairs with electronic controls.
This classification determines the level of regulatory control and certain requirements for registration.
Who Needs CDSCO Registration For Wheelchairs?
The CDSCO registration for wheelchairs is needed by the following:
Manufacturers – Entities producing wheelchairs.
Importers – Companies importing wheelchairs into India for sale.
Distributors – Firms distributing wheelchairs within India.
Any entities involved in the supply chain of wheelchairs should obtain CDSCO registration to operate legally in India.
Procedure for CDSCO Registration for Wheelchairs
Check the procedure for CDSCO registration for wheelchairs, We have mentioned all the easy steps down here:
- Check the Device Classification – Identify whether the wheelchair falls under class A or B.
- Appoint an Unauthorized Agent – For foreign manufacturers, appoint an authorized Indian agent to work together with the CDSCO.
- Prepare Documentation – Compile important documents, including technical specifications, quality certification, and manufacturing details.
- Submit Application – You are required to apply through the CDSCO online portal called SUGAM and provide all required information and documents.
- Review & Approval – The CDSCO reviews the application, can also conduct the inspection, and if everything is ok, you will get your CDSCO certificate.
Documents Required for CDSCO Registration of Wheelchairs
To get the CDSCO registration of wheelchairs, you must have these documents:
- Application Form
- Device Details
- Quantity Details
- Quality Certification
- Manufacturing Details
- Authorized Details
- Fee Payment Proof
- Device Master File
- Plant Master File
- Clinical Evaluation Report
- Risk Management Report
- Quality Management System
- BIS Certification
Timeline & Validity of CDSCO Registration for Wheelchairs
The CDSCO registration for wheelchair certification generally follows the mentioned timeline:
| S.No. | Title | Details |
|---|---|---|
| 1. | Application Review | 4 to 6 weeks (Approximately) |
| 2. | Inspection (If Required) | 2 to 4 weeks |
| 3. | Total Timeline | 2 to 3 months (Approximately) |
You should know that the CDSCO registration for wheelchairs is valid for 5 years, so it must be renewed within this time.
Why Choose ELT Corporate for CDSCO Registration?
ELT Corporate is the best regulatory agency available in India as of now. Here we provide support for CDSCO registration, ensuring a smooth and hassle-free procedure.
- Expert Guidance
- End-to-End Support
- Timely Updates
- Cost-Effective Solutions
Can I Import Wheelchairs Without CDSCO Registration?
No, you are not allowed to import a wheelchair without CDSCO registration in India. All wheelchairs should be certified with safety and quality standards.
Is CDSCO Registration Mandatory for Manual Wheelchairs Too?
Yes, the CDSCO registration is mandatory for manual wheelchairs too, before they can be legally sold in India.
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