How To Get BIS Certification For Medical Electrical Equipment?

Bureau of Indian Standards Certification plays a vital role in ensuring quality and compliance for products in India. As per the Bureau of Indian Standards Act of 2016, BIS is a national body responsible for setting standards and certifying products for quality, safety, and reliability.

A BIS Certificate is mandatory for Medical Electrical Equipment, ensuring consumer safety and adherence to regulatory standards. Without BIS approval, manufacturers or importers cannot sell or market Medical Electronic Equipment in India.

At ELT Corporate, we are here to assist you in obtaining a BIS Certificate for Medical Electrical Equipment. Whether you are a manufacturer or importer, simply connect with us, and our team will guide you through the complete process of getting BIS Certification for Medical Electrical Equipment to ensure safety and quality standards for public use.

What Is BIS Certificate For Medical Electrical Equipment?

BIS Certification for Medical Electrical Equipment is a mandatory certification issued by the Bureau of Indian Standards, ensuring that it complies with BIS’s safety, performance, and quality standards. Operating under the Ministry of Consumer Affairs, BIS provides third-party assurance that various products, including medical devices, meet defined quality, reliability, and safety benchmarks.

BIS is crucial in product certification, quality control, testing, hallmarking, and calibration activities. The primary objective of BIS is to safeguard public health by ensuring products adhere to strict safety and quality standards. By enforcing these regulations, BIS helps protect consumers from potential hazards while promoting consumer confidence and trust in certified products.

What Are Medical Electrical Equipment?

Medical Electrical Equipment are the devices that use electricity for medical purposes such as diagnosis, treatment, or monitoring of patients. Medical Electrical Equipment is designed to be in direct or indirect contact with patients and is subject to strict safety and performance standards due to its critical role in healthcare.

Examples:

• Electrocardiogram
• X-ray machine
• Patient monitors
• Infusion pumps
• Ultrasound machines

Also Read: BIS For Medical Devices

Who Can Apply For BIS Certification For Medical Electrical Equipment?

The following person or individual can apply for BIS Certificate for Medical Electrical Equipment:

1. Any manufacturer who wants to sell medical electrical equipment can apply for BIS Certification.
2. Importers who wish to market and sell medical electrical equipment in India can apply for BIS Certification.
3. An authorized person can apply for a BIS certificate on behalf of the manufacturer, importer, or foreign manufacturer or importer.

Benefits Of Obtaining BIS Certification For Medical Electrical Devices

Below are some significant benefits of obtaining a BIS certification for Medical Electrical Equipment:

• Ensures product quality and safety through rigorous testing.
• Enhances global recognition.
• Unlocks new market opportunities.
• Assure superior product quality through ISI Mark.
• Boosts consumer confidence and builds trust in the brand.
• Ensures compliance with regulatory standards.
• Reduces chances of product recall from the market or rejection.

Role Of BIS In Regulating Medical Electrical Equipment

BIS plays a significant role in ensuring the safety and quality of Medical Electrical Equipment in India. BIS develops and enforces quality and safety standards for medical devices, including Medical Electrical Equipment, ensuring they meet essential regulatory requirements.

BIS certification helps prevent substandard and unsafe products in the healthcare system, safeguarding patient safety and building trust in medical devices used nationwide.

Procedure For Obtaining BIS Certification For Medical Electrical Equipment

The following steps should be followed to obtain the BIS Certificate for Medical Electrical Equipment:

1. Visit the BIS portal
2. Fill out the application
3. Submit all the documents (Test reports from a BIS-recognized lab, Product specifications, user manuals, etc.)
4. Inspection of the Manufacturing site by BIS Officials
5. Review of application form and documents
6. Create Performance Report
7. After successful review and verification, the license is granted
8. Audit by BIS conducted at regular intervals to ensure compliance

Document Required For BIS Certification For Medical Electrical Products

To obtain BIS Certification for medical electrical equipment, several important documents are required to ensure compliance with the BIS regulations. Below is a list of the critical documents needed:

1. Application form
2. Personal details of the applicant
3. Product Details
4. Proof of Manufacturing/business establishment
5. Manufacturing License
6. Product test reports from a certified laboratory or third-party
7. Site Layout
8. MSME/SSI Certificate
9. List of equipment or Instruments
10. calibration certificate
11. Power of Attorney certificate, if any

Required BIS Standard For Medical Electrical Equipment

Below are some of the primary BIS standards for Medical Electrical Equipment:

• IS 23485: It specifies the requirements of a quality management system, where a company needs to demonstrate its ability to provide a medical device that consistently meets customers and regulatory requirements.
• IS/IEC 60601-1: This standard pertains to general requirements for basic safety and essential performance of Medical Electrical Equipment.
• IS/IEC 60601-1-6: This standard pertains to the usability of Medical Electrical Equipment, focusing on the design and evaluation of user interfaces.
• IS/IEC 60601-2: This series of IEC standards covers the specific requirements for Medical Electrical Equipment such as cardiac defibrillators, infusion pumps, and surgical equipment.

Validity Of BIS Certification For Medical Electrical Equipment

The validity of the BIS Certificate for Medical Electrical Equipment is one year from the date of issuance. After this period, the license can be renewed in the given time; otherwise, a fine of Rs 5000 is imposed.

Timeline For Obtaining A BIS Certificate For Medical Electrical Products in India

The timeline for obtaining BIS Certification for Medical Electrical Products in India typically ranges from 30 to 40 days. However, this may vary based on the product’s complexity and the application’s completeness.

How Can ELT Corporate Help You Obtain BIS Certification For Medical Electrical Equipment?

At ELT Corporate, our team of experts is dedicated to guiding you through obtaining BIS Certificate for Medical Electrical Equipment. We offer complete support, providing detailed information on all aspects of BIS Certification.

Our team will assist in analyzing your product’s requirements and specifications, ensuring a smooth certification process. We are committed to delivering timely and high-quality service, helping you meet regulatory standards efficiently.