Ensuring the safety and quality of medical devices is essential. In India, the BIS Certification for Medical Devices is one of the most trusted certifications. It ensures that medical devices meet the safety and quality standards set by the Bureau of Indian Standards (BIS).

What is BIS Certification?

The Bureau of Indian Standards (BIS) is India’s national standards body, established under the BIS Act of 1986. BIS develops and promotes standards across various sectors, including medical devices. For certain products, BIS Certification for Medical Devices is mandatory. This certification serves as a mark of quality, safety, and reliability for medical devices.

The primary purpose of BIS certification in the medical device sector is to ensure that devices adhere to stringent safety measures and quality standards, ultimately protecting healthcare professionals and patients.

In February 2022, the Ministry of Chemicals and Fertilizers, Department of Pharmaceuticals, released a list of BIS standards applicable to medical devices. You can check the list here.

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IS 23485 Certification Under BIS for Medical Devices

IS 23485 is an Indian Standard published by the Bureau of Indian Standards (BIS), derived from ISO 13485:2016, specifically tailored for the Indian medical device industry. This standard outlines the requirements for establishing a quality management system for medical devices to ensure product safety, quality, and regulatory compliance throughout the manufacturing and distribution process.

Under BIS regulations, certain categories of medical devices notified by the Indian government require mandatory certification, and compliance with IS 23485 under BIS is a key part of this process. Professional service providers assist medical device manufacturers in achieving IS 23485 certification by offering support in QMS documentation, internal audits, risk management, regulatory gap assessments, and certification audit readiness.

Implementing an IS 23485-compliant QMS not only ensures adherence to medical device regulatory compliance in India but also helps manufacturers enhance product reliability, reduce operational risks, and gain faster market approval through BIS certification for medical devices.

Is BIS Certification Mandatory for Medical Devices?

Yes, BIS Certification for Medical Devices is mandatory for maintaining safety measures and reducing risks associated with defective medical devices. As per Rule 7 of MDR 2017, medical devices must comply with BIS standards or, in the absence of such standards, conform to ISO or other pharmacopeial standards.

Despite the inclusion of Rule 7 in MDR 2017, compliance with BIS standards has only recently gained traction. Discussions are ongoing to strengthen Indian standards and ensure broader compliance.

BIS Certification

How to Get BIS Certification for Medical Devices?

Follow these steps to obtain BIS Certification for Medical Devices:

  1. Register or Login: Create an account on the BIS portal.
  2. Apply for the License: Submit your application.
  3. Complete the Application Form: Provide necessary details and upload required documents.
  4. Attach Documents: Include test reports and other supporting evidence.
  5. Submit the Application: Pay the requisite fees and submit your application.

Importance of BIS Certification for Medical Devices

  1. Market Access: Enables businesses to sell medical devices in India.
  2. Quality Assurance: Ensures compliance with BIS standards for safety and performance.
  3. Cost Efficiency: Reduces the need for multiple certifications and facilitates entry into international markets.
  4. Competitive Advantage: Builds trust and credibility, distinguishing businesses in the market.

How Operon Strategist Can Help

  • We will educate you on all aspects of the BIS certification. 
  • We will determine whether a product falls under the purview of BIS, including whether it complies with BIS standards, and then, after mutual agreement, the project will proceed. 
  • We will analyze the product requirements and provide specific recommendations. 
  • We have the resources to conduct a virtual pre-audit to determine whether your manufacturing unit and production process are in compliance with BIS requirements. 
  • You can expect timely service delivery  
  • We put in consistent attempts to satisfy BIS’s queries if any or expectations. 
  • We provide the best and most satisfactory solutions for any concerns related to the certification. 

Simplify Your Journey Toward BIS Certification for Medical Devices

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FAQs on BIS Certification for Medical Devices

BIS ensures that products meet Indian standards for safety and quality. The ISI mark on a product signifies compliance with BIS guidelines.

Class A and B medical devices require a license from October 1, 2022, with the same mandate for Class C and D devices.

Standards like ISO 13485 (QMS for medical devices) and ISO 14971 (risk management) are also critical for compliance.

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