CDSCO Import Registration for Wheelchairs: Manual (Class A) vs Electric (Class B)

Understand CDSCO Registration for Wheelchairs

Importing wheelchairs into India is regulated by the Central Drugs Standard Control Organization (CDSCO). The import requirements vary based on the classification of the device:

Manual Wheelchairs: Class A (Non‑Sterile, Non‑Measuring) — Registration required (no MD‑15 Import License).
Electric or Motorized Wheelchairs: Class B — Import License required (MD‑15).

Why Registration or Import License is Important

Both Manual and Electric wheelchairs must be approved by CDSCO to ensure quality, patient safety, and traceability. Registration (for Class A NSNM) and Import License (for Class B) are mandatory before selling or distributing wheelchairs in the Indian market.

Wheelchair Classification Under CDSCO Rules

Manual Wheelchair: Class A (NSNM) – Registration required via CDSCO portal.
Electric/Motorized Wheelchair: Class B – Requires an Import License (MD‑15) through the CDSCO online portal.

CDSCO Registration for Manual Wheelchairs (Class A NSNM)

Manual wheelchairs must be registered online. This is a quick process:

Confirm the classification of the device.
Sign in to the CDSCO online portal.
Enter details about the device, manufacturer, and importer.
Upload required documents, including:
- Company and device details
- Importer information and authorization documents
- Free Sale Certificate or site proof
- Self-certification documents
Receive an instant Registration Number upon submission.

✅ Validity: No expiry date.

CDSCO Import License for Electric Wheelchairs (Class B)

For electric or motorized wheelchairs:

Confirm classification as Class B Medical Device.
Sign in to the CDSCO portal and apply for an Import License (MD‑15).
Upload required documents:
- Importer and manufacturer details
- Free Sale Certificate (FSC)
- Plant Master File (PMF) & Device Master File (DMF)
- ISO 13485 Certificate
- Power of Attorney from manufacturer
Upon review and query response, obtain the MD‑15 Import License.

✅ Validity: MD‑15 is valid indefinitely, subject to retention and compliance.

Documents Required for CDSCO Import Registration for Wheelchairs

Classification	Documents Required
Manual Wheelchair (Class A NSNM)	– Company & device details – Importer information – Free Sale Certificate / site proof – Self-certification documents
Electric Wheelchair (Class B)	– Company & device details – Importer information & authorization – DMF & PMF – FSC and site documents – Power of Attorney (PoA) – ISO 13485 Certificate

Timeline & Validity

Class A NSNM Registration: Instant upon submission, no expiry.
Class B Import License (MD‑15): Up to 9 months for processing. Valid indefinitely, subject to compliance and retention.

Summary

Device Type	Class	Registration/Import Requirement
Manual Wheelchair	A NSNM	Registration (no MD‑15)
Electric Wheelchair	B	Import License (MD‑15 required)