FMCS License Guide: Scheme I & Scheme X for Foreign Manufacturers

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fmcs license

Introduction

India’s BIS certification landscape is evolving, and for foreign manufacturers, it is now critical to understand which certification pathways apply to your products.

Two key schemes (Scheme I and Scheme X) both require factory inspection and grant certification which is essential for legal market entry in India.

This guide is dedicated to helping you navigate the process for obtaining an FMCS license under Scheme I, and understanding when Scheme X may apply instead.

We’ll cover:

  • What an FMCS license is
  • How Scheme I operate
  • FMCS license certification process
  • What is Scheme X and how it differs
  • Scheme I vs Scheme X — key differences
  • Tips for a smooth certification journey

What is an FMCS License?

An FMCS license allows foreign manufacturers to export specific regulated products to India under the authority of the Bureau of Indian Standards (BIS).

FMCS stands for Foreign Manufacturers Certification Scheme a pathway under Scheme I of India’s BIS Conformity Assessment system.

Products certified under the FMCS license display the ISI Mark, indicating full compliance with Indian standards.

Without this license, regulated products cannot legally enter or be sold in the Indian market. Customs enforcement is strict, and non-compliance can result in shipment holds, fines, or rejection.


Scheme I — ISI Mark Scheme

Scheme I covers a wide range of products that must carry the ISI Mark to demonstrate compliance with Indian Standards.

The FMCS license is the route through which foreign manufacturers obtain this certification.

Key points about Scheme I:

  • FMCS license applies to Scheme I products manufactured outside India
  • Certification is granted following a detailed factory inspection and product testing
  • Products must be marked with the ISI Mark as per BIS guidelines

Some covered categories include:

  • Cement
  • Household electrical goods
  • Batteries
  • Medical equipment
  • Steel and iron products
  • Automotive components

BIS regularly updates this list. Below is the link to the – Product under the compulsory certification list (ISI Product List)

If your product is not covered under this scheme, it may fall under India’s Scheme X certification requirements or the CRS Scheme for electronics.


FMCS License Certification Process (Scheme I)

Here is the step-by-step process for obtaining an FMCS license under Scheme I:

1. Appoint an Authorized Indian Representative (AIR)

Your AIR will act as your official liaison with BIS in India.

2. Submit Application

Prepare and submit a comprehensive application, including:

  • Company and product details
  • Manufacturing process overview
  • Test reports from recognized labs
  • Supporting compliance documents

3. Factory Audit

BIS conducts an on-site factory inspection to assess:

  • Production quality and process controls
  • Testing capabilities
  • Product marking and labeling

4. Product Testing

Products undergo testing at BIS-approved laboratories to verify compliance with relevant Indian Standards.

5. Certification Grant

Upon successful completion of the above steps, BIS issues your FMCS license, authorizing the use of the ISI Mark.

6. Surveillance and Renewal

BIS conducts periodic surveillance audits and testing to ensure ongoing compliance.


Understanding Scheme X

Scheme X is a newer certification pathway introduced under India’s expanding Conformity Assessment framework.

While not part of Scheme I, it is important for foreign manufacturers to understand Scheme X, because — like Scheme I — it also requires factory inspection and product testing.

Key points about Scheme X:

  • Covers specific products notified under recent Quality Control Orders (QCOs)
  • Focuses on industrial and heavy equipment sectors
  • Certification results in a Certificate of Conformity (CoC) — not an ISI Mark
  • Factory inspection by BIS is mandatory
  • Technical File submission and detailed product documentation required

Products currently covered under Scheme X include:

  • Heavy machinery
  • Switchgear
  • Compressors
  • Packaging equipment
  • Mining equipment

Many Scheme X categories will see active enforcement from August 2025 onward.


Scheme I vs Scheme X — Key Differences

Here is a quick comparison to help you understand when an FMCS license under Scheme I is needed, versus when Scheme X certification applies:

AspectFMCS License (Scheme I)Scheme X Certification
Applicable ProductsConsumer goods, industrial goodsHeavy machinery, electrical equipment
MarkingISI MarkCertificate of Conformity (CoC)
Factory InspectionRequiredRequired
Technical FileRequiredRequired
Product TestingBIS-recognized labsBIS-recognized labs or equivalent
Certification AuthorityBISBIS
Typical Timeline~6–8 months~9–12 months

Tips for a Smooth Certification Journey

If you are pursuing an FMCS license or preparing for Scheme X compliance, here are some practical tips to enhance your success:

  • Choose an experienced AIR
    A knowledgeable Authorized Indian Representative can streamline the process and prevent costly delays.
  • Prepare a complete Technical File
    Missing or poorly organized documentation is a leading cause of application rejections.
  • Ensure factory audit readiness
    BIS audits are detailed — your team must be prepared to demonstrate compliance at every step.
  • Follow marking guidelines exactly
    Incorrect product marking can lead to compliance issues or shipment holds.
  • Plan ahead
    Certification processes typically take 6 to 12 months. Starting early helps align with your export timelines.

At NKG Advisory, we guide foreign manufacturers through both FMCS license applications and Scheme X certification — ensuring faster approvals and smoother market access.


Conclusion — Prepare Your Compliance Strategy

If your products fall under Scheme I, obtaining an FMCS license is essential for legal market entry into India. For products covered under Scheme X, understanding the newer compliance requirements is equally critical.

Both pathways involve factory inspection and product testing — and both demand careful preparation and expert guidance.

If you are ready to begin your certification journey or need clarity on which scheme applies to your products, we’re here to help.

Contact NKG Advisory today — and let’s move your compliance forward.

And if you are looking for more insights on compliance, certifications, and industry updates? Explore our blog page for expert guidance and actionable information. Visit Now


Please refer to the below links, for products under BIS

How NKG can help:

For the past two decades, NKG has been helping more than five thousand clients worldwide, across the healthcare spectrum, to get their products registered. The dedicated regulatory team of NKG has more than ten years of experience in helping clients cross the hurdles they face while marketing their products to sell or distribute in India.

 

Have a query, drop it at contact@nkgabc.com

Picture of Navraj Bindra
Navraj Bindra

Navraj Bindra is a Director - Regulatory Expert & Strategy at NKG. He is behind regulatory approvals of more than 1500 beauty brands in India. He has spent 10 years in NK Group which was founded by his father Mr. GK Bindra in 2005.The name NKG now synonymous with reliability, transparency and efficiency in India & the world. The core team is a family with Founder & Father Mr. GK Bindra & two sons Navraj Bindra & Karan Bindra who work together.

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