Sell Medical Products on GeM – Registration, Documents & Compliance

Who Can Sell Medical Products on GeM

Medical products on GeM can be sold by:

• Manufacturers (OEMs)

• Authorized distributors / dealers

• Importers (with regulatory approvals)

• MSMEs supplying consumables & equipment

Step-by-Step Registration to Sell Medical Products on GeM

 Step 1: GeM Seller Registration

To start selling, you must complete:

• Business registration on GeM

• PAN & Aadhaar verification

• Bank account validation

• GST authentication

✔ GeM registration is free, but accuracy is critical.

 Step 2: Category Activation (Medical Products)

After registration:

• Apply for Medical Products / Healthcare category

• Upload basic compliance documents

• Await category approval

 Category approval is mandatory before listing products or bidding.

 Step 3: Product Listing / Bid Participation

Depending on the buyer’s requirement:

• List approved medical products in catalogue, or

• Participate directly in bids / BOQ-based tenders

 Product specifications must match exactly with tender requirements.

Product-Specific Mandatory Documents

Depending on the product type, you may need:

 For Medical Devices & Equipment

• CDSCO Registration / License (mandatory for regulated devices)

• OEM Authorization Letter

• BIS Certification (if applicable)

• Product technical datasheet

• Warranty & service commitment

 For Medical Consumables

• Manufacturing / import license

• Quality certification

• Batch & shelf-life details

• BIS / safety certification (where applicable)

 Wrong or expired documents are the #1 reason for rejection.

CDSCO Compliance – Critical for Medical Devices

Most medical devices sold on GeM fall under CDSCO regulation.

You must ensure:

• Device is correctly classified

• CDSCO registration matches the product model

• Import license (if applicable)

• Manufacturer–importer linkage is valid

 Selling CDSCO-regulated devices without approval can lead to blacklisting.

Make in India & Local Content Declaration

All medical sellers must declare local content classification.

Pricing & L1 Rules for Medical Products

Government evaluates:

• Total landed cost (not just unit price)

• Installation & commissioning

• AMC / CMC (where required)

• Taxes & statutory charges

Abnormally low pricing can trigger scrutiny or bid cancellation.

How Leegal Helps Medical Sellers on GeM

Leegal acts as a compliance and risk-management partner for medical suppliers.

✔ GeM seller & category registration support

✔ CDSCO, BIS & OEM compliance validation

✔ Product eligibility & rejection-risk audit

✔ Bid & post-order execution support

✔ Legal remedies in rejection, cancellation & penalties

We help medical vendors sell safely, scale sustainably, and stay compliant.