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Understanding BIS Compliance in India
Manufacturers and importers need to be aware of the Indian market. India has a large domestic market and is one of the largest manufacturing countries.
Some products require compliance with Indian standards for product quality and product safety. These standards may also impose requirements for product certification and/or product marking.
Products that are subject to BIS requirements must be manufactured, imported and marketed in accordance with the applicable BIS schemes. Compliance with these requirements prevents delays and problems with the market authorization of the product in India.
What is BIS Compliance?
BIS sets product standards and offers different schemes for conformity assessment.
Manufacturers may be required to obtain BIS approval in the form of a license or a registration to market their products in India.
These requirements are different for each product category. Other considerations are the product specification, the location of the manufacturer, and the QCO.
BIS offers different schemes of conformity assessment. The manufacturer is required to determine the applicable requirements prior to initiating the conformity assessment.
Why is BIS Compliance Important?
Compliance with the requirements set by BIS enables the manufacturer to market the product in India.
For manufacturers and importers, numerous risks can include:
- Rejection of goods
- Problems with customs and import duties
- Delays in sales and distribution
- Lack of required legal authorization
- Loss of business and goodwill
- Additional costs for inspection and testing
Non-compliance with laws can result in a combination of the above mentioned and other risks.
Which Products Need to Have a BIS Certification?
Various products in multiple market segments need BIS consultant. Some market segments are automobiles and auto parts, electrical and electronic products, machinery and equipment, chemicals, and construction and building materials.
Depending on the assessment and interpretation of the legal requirements, certain products may require a BIS Compulsory Registration, while others may require an ISI mark or other BIS assessments.
Therefore, assessment of a product is of prime importance.
BIS Certification Process for Manufacturers
It is mandatory for manufacturers to assess the Indian Standards and processes for conformity and compliance to submit an application for product approval to the BIS.
Other activities may include, but are not limited to:
- Identifying Indian Standards pertaining to the product.
- Analyzing and understanding the product’s and/or the company’s ability and willingness to accept the requirements of the Indian Standards.
- Preparing and assembling documents relevant to the assessment and production of the product.
- Getting the product tested at a lab.
- Preparing an application for BIS approval.
- Allowing and complying with an inspection at the manufacturer’s site.
- Addressing BIS’s concerns and requests for additional information and/or product improvements.
- Obtaining an approval/license from BIS.
Requirements for Foreign Manufacturers
Besides Indian regulatory requirements, foreign manufacturers may also have to comply with certain BIS requirements.
This may include the following:
Finding out the Indian Standard relevant to the product
Having the product sampled and tested
Preparing documentation relating to the product and factory
Appointing BIS authorized representatives
Communicating with the BIS
Submitting documentation relating to the overseas manufacturing facility
Complying with the relevant requirements for the assessment of product conformity
Prior to export of regulated products to India, foreign manufacturers should verify the requirements applicable to them.
Common Documentation
The documents to be submitted by a company would depend on the product and certification required. Some of the information required could include:
Product design and construction details
Testing done, if any
Raw material and components used
Equipment used
Quality control and assurance
Trade secrets and intellectual property
Factory layout and process
Authorization of foreign manufacturers
Accurate and complete documentation by the manufacturer will help to speed up the certification process.
Importance of Product Testing
Product testing may form part of the certification process.
Products may have to be tested for various aspects such as performance, safety, and durability. Furthermore, product standards may require tests for electrical and electronics product safety and other relevant product characteristics.
It is important that businesses identify the specific product standard and the tests required before selecting a test laboratory and/or producing samples for testing. Testing the wrong product may lead to delays and increased costs.
Many challenges occur during the assessment of compliance to BIS specifications including, but not limited to:
1. Accepting the Applicable Standard
2. Lack of Suitable Documentation
3. Inadequate Testing
4. Evaluation of Factory Premises
5. Variation in Requirements
In addition to the above listed challenges, the Standards and Regulatory requirements of India are dynamic, and therefore, it is essential to review the most current requirements.
There are established ways for industry to prepare for BIS certification. These ways, when followed, will help Industry ease the burden of complying with BIS certification and related requirements.
BIS Certification Is Specific to Products
An important understanding for businesses is that compliance with BIS is determined by evaluating a product’s complete specification, and not by a product’s common or generic name.
Products can be differentiated by specifications and standards. Also, similar products can be governed by different legal requirements.
It is important for manufacturers and importers to identify the regulations applicable to their products, prior to initiating the process for BIS certification.
Identification and interpretation of Indian product regulations is a specialist task, and a number of BIS certification consultants in India are available to assist in this regard.
Manufacturers and importers should understand that compliance with regulations of BIS is mandatory to sell regulated products in India. Prior to initiating the process of compliance, companies should understand all facets of the process, including testing, documentation and factory requirement.
Companies should integrate understanding of regulatory requirements into their product launch process, and not consider certification as end of process product launch function. Early identification of product compliance requirements will help avoid surprises and delays in obtaining product certification.
