Is Your Product Covered by a BIS Quality Control Order? A Market-Entry Check for Foreign Manufacturers

SKMC Global | Blogs & Updates | Is Your Product Covered by a BIS Quality Control Order? A Market-Entry Check for Foreign Manufacturers

Introduction

Exportation of the products to India involves compliance with relevant BIS regulations by the foreign manufacturer. The initial step involves determining whether the BIS QCO is relevant to foreign manufacturers. Products covered by a Quality Control Order must undergo the BIS certification process in order to be exported to India.

Knowing the BIS FMCS applicability, identifying products requiring BIS certification and making sure that BIS compliance for imports are fulfilled are critical stages for foreign producers who plan to supply products to the Indian market.

A variety of mandatory BIS certification requirements have been established by the Indian government to control the quality of the goods. Thus, the foreign manufacturers are to examine the BIS requirements for their export of products, appointment of distributors and negotiation with the Indian customers.

What is a BIS Quality Control Order (QCO)?

Quality Control Order (QCO) refers to a government notification where certification from BIS becomes compulsory for certain goods prior to their manufacture, import, sale or distribution in India.

The purpose of QCOs is to:

  • Ensure that products entering the Indian market meet prescribed quality and safety standards.

  • Prevent the supply of sub-standard or unsafe products.

  • Protect consumers and Indian industries from non-compliant goods.

  • Promote uniform product quality across domestic and imported products.

For foreign manufacturers, a QCO is a mandatory market-entry requirement. If a product is covered under a QCO, BIS certification is required before it can be exported to India.

Why QCO Applicability Must Be Checked Before Exporting to India

Several foreign manufacturers assume that their ability to satisfy the requirements set by buyers is sufficient to sell in India. However, when a certain commodity is included within QCO, BIS certification becomes a must for the manufacturer.

Identifying the requirement of QCO at an early stage is beneficial for manufacturers as:

  • Helps in determining whether BIS certification is compulsory or not.

  • Provides information regarding the type of certification procedure involved.

  • Allows one to assess the duration and cost of certification.

  • Saves the product from any sort of delay once it reaches the shipping port.

  • Facilitates its smooth clearance at customs in India.

Any delay in getting BIS approval may impact on supply commitments, production planning and even customer relations. Hence, BIS assessment should be done prior to any commercial shipment.

How to Identify the Relevant Indian Standard

Once a product is identified as being covered under a QCO, the next step is determining the correct Indian Standard (IS).

Key factors to evaluate include:

  • Scope and applicability of the Indian Standard.

  • Product specifications covered under the standard.

  • Testing parameters and performance requirements.

  • Applicable product categories and classifications.

Selecting the wrong Indian Standard may result in:

  • Rejection of the BIS application.

  • Additional testing requirements.

  • Delays in obtaining certification.

  • Increased compliance costs.

Therefore, technical evaluation before filing the BIS application is highly recommended.

FMCS vs CRS vs Scheme X – Which Scheme Applies?

BIS has launched various certification schemes based on the product types and requirements. Choosing the right certification process is necessary for speedy clearance.

Foreign Manufacturers Certification Scheme (FMCS)

The BIS FMCS applicability generally covers foreign manufacturers whose products are notified under mandatory BIS certification requirements.

Under FMCS:

  • The foreign manufacturing facility is assessed by BIS.

  • Product samples are tested through BIS-recognized laboratories.

  • Compliance with applicable Indian Standards is verified.

  • BIS license is issued after successful evaluation.

Compulsory Registration Scheme (CRS)

CRS mainly applies to specific electronic and IT products.

Key features include:

  • Product testing through recognized laboratories.

  • Registration of products with BIS.

  • Compliance with specified Indian Standards.

Scheme - X

Scheme X applies to specific notified products covered under applicable Quality Control Orders (QCOs). The Machinery and Electrical Equipment Safety (Omnibus Technical Regulation) Order, 2024, under which many machinery products were covered, was withdrawn in January 2026. However, Scheme X continues to apply to products specifically notified by the Government.

It may involve:

  • Product conformity assessment.

  • Factory evaluation.

  • Technical documentation review.

  • Verification of compliance with applicable standards.

Selecting the correct scheme depends on the product category, applicable QCO and regulatory notification.

Product Variants, Models and Series – Does One License Cover Everything?

Usually, foreign manufacturers may export more than one model or variant of the same product family in India. It is important to determine beforehand that whether a single BIS license would be sufficient for all the models.

It depends upon:

  • Design of the product and its specifications.

  • Applicability of the Indian Standard to the product.

  • Guidelines laid down by the BIS regarding product inclusion.

  • Testing of different models.

It is important to do proper product mapping.

Consequences of Importing a Regulated Product Without BIS Approval

Importing products covered under mandatory BIS requirements without valid certification can create significant regulatory and commercial risks.

Possible consequences include:

  • Delay or restriction in customs clearance.

  • Additional storage and logistics costs.

  • Regulatory action against importers or suppliers.

  • Business disruption due to non-availability of products.

  • Negative impact on customer confidence.

BIS compliance should therefore be considered a critical market-entry requirement rather than a post-import activity.

BIS Market-Entry Assessment Checklist

Before exporting products to India, foreign manufacturers should complete the following assessment:

  • Check whether the product is covered under any active QCO.

  • Identify the applicable Indian Standard.

  • Determine whether FMCS, CRS, Scheme X or another approval route applies.

  • Review product variants and model coverage requirements.

  • Evaluate testing and documentation requirements.

  • Estimate certification timelines and commercial impact.

  • Plan BIS approval before shipment initiation.

A structured assessment enables manufacturers to enter the Indian market with minimal regulatory risks.

When Should You Appoint a BIS Consultant?

Foreign manufacturers should engage a BIS consultant during the initial market-entry planning stage, preferably before finalizing exports to India.

A BIS consultant can help with:

  • Product applicability assessment.

  • Identification of relevant Indian Standards.

  • Selection of appropriate BIS certification scheme.

  • Documentation preparation.

  • Coordination with BIS authorities.

  • Managing certification timelines.

  • Addressing regulatory queries.

Professional support becomes particularly useful for companies dealing with multiple products, complex specifications or frequent product modifications.

How SKMC Global Can Help

SKMC Global provides end-to-end regulatory support to foreign manufacturers, exporters and international companies seeking to establish compliant operations in India.

Our team assists businesses with:

  • Assessment of BIS QCO applicability for foreign manufacturers.

  • Evaluation of BIS FMCS applicability.

  • Identification of products requiring BIS certification.

  • Determination of applicable Indian Standards.

  • Selection of appropriate BIS certification routes.

  • Documentation and application support.

  • Coordination with BIS authorities.

  • Regulatory compliance management.

With expertise across customs, trade compliance and product regulations, SKMC Global helps businesses develop practical compliance strategies that support smooth market entry into India.

Conclusion

Certification under BIS regulations are an important factor for international manufacturers that export goods to India. Knowing about BIS FMCS scope, the types of products that need BIS certification and BIS compliance for imports will help you enter the Indian market without any problems. Using our expertise at SKMC Global, foreign manufacturers will be able to easily obtain BIS certification.

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