BIS Certification
Businesses that plan to manufacture, import, or sell regulated products in India must obtain the appropriate BIS Certification to ensure legal market access. This certification is mandatory for a wide range of categories including medical devices, electronics, IT products, household appliances, construction materials, and chemicals.
At Operon Strategist, we support manufacturers and importers with end-to-end BIS consulting services—helping you achieve timely approvals, maintain regulatory compliance, and ensure uninterrupted product availability in the Indian market.
What is BIS Certification?
The Bureau of Indian Standards (BIS) is the national standards authority under the Ministry of Consumer Affairs. It develops, maintains, and regulates the safety, quality, and performance standards of products sold in India.
BIS Certification confirms that a product complies with the relevant Indian Standards (IS), and is safe for manufacturing, import, sale, and use in India.
While many products can apply voluntarily, certain categories fall under mandatory certification as per Quality Control Orders (QCOs) issued by the Government of India. These products must obtain BIS approval before entering the Indian market—ensuring consumer safety and meeting regulatory requirements.
IS 23485 Certification Under BIS for Medical Devices
IS 23485 is India’s adaptation of ISO 13485:2016, created specifically for the Indian medical device sector. This standard outlines the Quality Management System (QMS) requirements for medical device manufacturers to ensure product safety, reliability, and regulatory compliance.
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Under BIS regulations, certain medical devices notified by the Indian government require mandatory certification—and compliance with IS 23485 is a key requirement.
Professional BIS consultants like Operon Strategist help manufacturers implement IS 23485 through:
QMS documentation and implementation
Internal audits and gap assessments
Risk management as per regulatory expectations
BIS certification audit readiness
Implementing an IS 23485-compliant QMS accelerates market approval, improves product reliability, and ensures smooth compliance with India’s medical device regulations.
BIS Standards by Product Category
| Product Category | Relevant BIS Standard | Description |
|---|---|---|
| Medical Device Quality Management | IS 23485: 2019 | Indian adaptation of ISO 13485 for medical device QMS |
| Blood Pressure Measuring Devices | IS 3390: 2014 | Standard for sphygmomanometers |
| Infrared Thermometers | IS 3055 (Part 4): 2004 | Safety and performance for medical thermometers |
| Medical Electrical Equipment | IS/IEC 60601 series | Electrical safety standards for medical equipment |
| Electronics (under CRS) | IS 13252 (Part 1): 2010, IS 616: 2017 | IT equipment and household electrical appliances safety |
| LED Lamps | IS 16102 (Part 1): 2012 | Requirements for self-ballasted LED lamps |
| Cement | IS 1489 (Part 1): 1991, IS 1489 (Part 2): 1991 | Specifications for Portland Pozzolana Cement |
| Steel Products | IS 2062: 2011 | Hot rolled medium and high tensile structural steel |
BIS Compulsory Certification for Products in India
To safeguard public health and maintain product quality, BIS certification is mandatory for several product categories in India. While certification is generally voluntary for many products, the central government mandates BIS certification for specific categories via Quality Control Orders (QCOs), ensuring compliance with Indian Standards before products are sold in the Indian market.
Currently:
380 products are listed under compulsory BIS Certification through the ISI Mark Scheme (Scheme-I) across sectors like electronics, chemicals, construction materials, and household appliances.
738 products qualify for voluntary BIS Certification, helping manufacturers demonstrate superior product quality and build market trust.
Additionally, the Ministry of Electronics and Information Technology (MeitY) has listed 77 electronics and IT products under the Compulsory Registration Scheme (CRS), requiring registration prior to sale in India.
Types of BIS Certification Schemes
BIS certification is granted under different schemes depending on the nature of the product and applicable regulatory requirements:
ISI Mark Scheme (Scheme-I) for Domestic Manufacturers
This is applicable for products that come under compulsory BIS certification. Manufacturers must apply for certification either through the normal procedure or the simplified procedure if specified for certain products.
- Normal Procedure:
The manufacturer must submit Form V along with all required documents and applicable fees to the BIS office that has jurisdiction over the manufacturing location. Following this, BIS officers conduct a preliminary factory evaluation to inspect production processes and collect product samples. These samples are sent to BIS-recognized laboratories for independent testing. If the products meet the relevant Indian Standards, the manufacturer is granted a BIS license to use the ISI mark on the certified products. - Simplified Procedure:
Certain products under compulsory certification are eligible for a simplified, faster certification process. If a product appears on this list, the manufacturer can opt for this streamlined route to obtain certification more efficiently.
- Normal Procedure:
Compulsory Registration Scheme (CRS)
This scheme is specifically designed for electronics and IT products as notified by MeitY. Under this scheme:
- Products must be registered with BIS before being introduced to the Indian market.
- Unlike the ISI Mark Scheme, factory inspection is not required.
- Manufacturers need to have their products tested in BIS-recognized laboratories and submit the test reports to BIS along with the registration application.
How Operon Strategist Can Help?
At Operon Strategist, we bring regulatory expertise, proven experience, and a trusted consulting approach to ensure your BIS Certification process is smooth and compliant. Our end-to-end support is structured to reduce delays, eliminate compliance risks, and help you achieve faster market access.
Our Services Include:
BIS guidance & regulatory education to help you understand applicable standards.
Product classification & applicability check for correct certification pathways.
Gap analysis & documentation support to meet BIS and Indian Standards requirements.
Virtual pre-audit to confirm QMS and process readiness.
Timely application submission & follow-up to prevent approval delays.
Handling BIS queries with accurate, audit-ready responses.
Full support until certification is granted, ensuring a seamless experience.
With strong domain expertise and a reliable compliance process, Operon Strategist helps manufacturers and importers achieve BIS approval quickly and confidently.
Simplify Your Journey Toward BIS Certification
FAQs on BIS Certification
BIS Certification is a conformity assessment mark issued by the Bureau of Indian Standards to verify that products meet specified Indian standards and regulatory requirements.
Electronics, telecom equipment, safety devices, locking systems, and other regulated goods under the Compulsory Registration Scheme (CRS) must obtain BIS Certification before being sold in India.
Common documents include product specifications, test reports from accredited labs, manufacturing details, quality control plan, and user manuals.
No, if your product falls under the mandatory BIS list, you cannot sell or import it in India without proper certification.
A consultant ensures accurate documentation, smooth coordination with labs, and faster approvals, reducing the chances of rejection or delays.
Yes, products that fall under the BIS compulsory registration list must be certified even if they are manufactured outside India before they can enter the Indian market.