CDSCO Import License for Surgical Gloves: Complete Guide

Understand CDSCO Import License for Surgical Gloves

Surgical gloves are classified as medical devices in India, and obtaining a CDSCO Import License for Surgical Gloves is mandatory before introducing them to the Indian market. This applies to both sterile and non‑sterile variants, ensuring that only quality medical devices are imported and sold across the country.

Why is a CDSCO Import License for Surgical Gloves Mandatory?

A CDSCO Import License for Surgical Gloves ensures:

Compliance with Medical Devices Rules, 2017.
Quality and patient safety.
Traceability and accountability in case of quality issues.
Preventing entry of counterfeit or substandard medical products.

Classification of Surgical Gloves Under CDSCO Rules

Sterile Surgical Gloves: Class B Medical Devices (Import License required).
Non‑Sterile Surgical Gloves: Class A NSNM Devices (Registration required, no MD‑15 required).

Who Needs a CDSCO Import License for Surgical Gloves?

Foreign manufacturers intending to export surgical gloves to India.
Indian importers and authorized agents.
Distributors and suppliers introducing surgical gloves for clinical use.

Procedure for CDSCO Import License for Surgical Gloves (Class B)

Confirm that the device is classified as Class B.
Appoint an Authorized Agent in India (must have Form 20B/21B).
Log in to the CDSCO SUGAM portal.
Submit the application in Form MD‑14, providing:
- Importer and manufacturer details.
- Product classification and specifications.
Upload required documents:
- DMF (Device Master File)
- PMF (Plant Master File)
- FSC (Free Sale Certificate)
- Power of Attorney
- ISO 13485 Certificate
- Importer’s wholesale or manufacturing license (Form 20B/21B)
Application Fee:
- $2000 for site registration
- $1000 for each device
Respond to CDSCO queries within 45 days.
Upon satisfactory review, receive Form MD‑15 Import License.

Documents Required for CDSCO Import License for Surgical Gloves

Document Name	Purpose
Application (MD‑14)	Main import application form
Device Master File (DMF)	Detailed device specifications and design
Plant Master File (PMF)	Details about the manufacturing site
Free Sale Certificate (FSC)	Verifies market authorization in the manufacturer’s country
Power of Attorney	Authorizes the Indian Agent to represent the manufacturer
ISO 13485 Certificate	Shows the manufacturer’s quality standards
Wholesale / Manufacturing License (Form 20B/21B)	Enables import and sale of medical devices in India

Timeline & Validity of the CDSCO Import License for Surgical Gloves

Processing Time: ~6–9 months, including query responses.
Query Response Period: 45 days.
Validity: The MD‑15 Import License is indefinite, subject to retention every 5 years.

Summary: CDSCO Import Registration for Surgical Gloves

Device Type	Class	Registration / Import License
Sterile Surgical Gloves	Class B	MD‑15 Import License required
Non‑Sterile Surgical Gloves	Class A NSNM	Registration required, no MD‑15 needed