BIS Certification for Medical Devices in India

In today’s global marketplace, businesses must adhere to international standards to guarantee the quality and safety of their products. One of the most esteemed certifications in India is the Bureau of Indian Standards (BIS) certification. In this blog, we will explore the significance and advantages of obtaining BIS certification in India.

What is IS 23485 Certification?

IS 23485 is a newly introduced standard by the Bureau of Indian Standards (BIS) that specifically targets medical devices. This standard focuses on the essential requirements for Quality Management Systems (QMS) as well as the key principles of Safety and Performance for medical devices.

With the launch of IS 23485, BIS has set a new benchmark for medical devices, highlighting the importance of compliance with fundamental safety and performance standards alongside the requirements for effective Quality Management Systems. This certification ensures that organizations align their practices with these critical guidelines, enhancing the overall quality and safety of medical devices in the market.

What is BIS Certification?

The Bureau of Indian Standards (BIS) is India’s national standard body, established under the Bureau of Indian Standards Act of 1986. It plays a crucial role in developing and promoting standards across various sectors, including products, services, and systems. BIS certification is mandatory for certain products in India, serving as a mark of quality, safety, and reliability.

In the context of medical devices, BIS aims to uphold the healthcare system by monitoring the quality of devices used in medical settings. This ensures that all medical devices comply with safety measures established by BIS authorization. On February 1, 2022, the Ministry of Chemicals and Fertilizers, Department of Pharmaceuticals, Government of India, published a list of BIS standards specifically applicable to medical devices. This certification is essential for ensuring that healthcare professionals and patients can trust the safety and effectiveness of medical devices in use.

Is BIS Standard Mandatory for Medical Devices?

BIS standards for medical devices are essential for ensuring compliance with Indian regulations aimed at maintaining safety and minimizing health risks associated with device defects. Currently, only a limited number of manufacturers have obtained BIS licenses for their medical devices. According to Rule 7 of the Medical Device Rules (MDR) 2017, all medical devices must conform to the standards established by BIS.

In cases where no specific BIS standard exists for a medical device, the device must adhere to standards set by the International Organization for Standardization (ISO) or other recognized pharmacopeial standards. If neither option is available, the device should comply with the validated standards of the manufacturer.

Although Rule 7 has been part of the Indian MDR 2017, the Central Drugs Standard Control Organization (CDSCO) has not consistently required proof of compliance with Indian standards from reviewers and signatories. Recently, there have been ongoing discussions between BIS and the Department of Pharmaceuticals regarding the need to strengthen Indian standards for medical devices. Compliance with BIS standards is crucial for ensuring the safety and effectiveness of medical devices in the healthcare system.

How to Get BIS Certificate?

• Register / Login

• Apply for the license

• Fill out the application form

• Attach necessary documents

• Complete the application form and submit it along with the required fees.

Importance of BIS Certification

BIS certification is vital for businesses aiming to market their products in India. It is a mandatory requirement for various categories, including electrical goods, toys, and food products. Obtaining BIS certification guarantees that products meet Indian standards, safeguarding consumers from substandard and unsafe items. Additionally, BIS certification enhances trust and credibility, allowing businesses to build stronger relationships with their customers and improve their market reputation. By adhering to these standards, companies not only comply with regulations but also demonstrate their commitment to quality and safety.

How We Assist You in Obtaining BIS Certification

At our company, we guide you through every aspect of the BIS certification process. Here’s how we can help:

• Comprehensive Education: We provide detailed information on all facets of BIS certification, ensuring you understand the requirements.

• Product Assessment: We evaluate whether your product falls under BIS regulations and confirm its compliance with BIS standards. After mutual agreement, we will initiate the certification project.

• Tailored Recommendations: Our team analyzes your product requirements and offers specific, actionable recommendations to meet BIS standards.

• Virtual Pre-Audit: We conduct a virtual pre-audit to assess your manufacturing unit and production processes for compliance with BIS requirements.

• Timely Service Delivery: We prioritize efficiency and ensure that our services are delivered promptly.

• Responsive Support: We proactively address any queries or expectations from BIS, striving to satisfy their requirements consistently

• Effective Solutions: Our team is committed to providing optimal solutions for any concerns related to the certification process.

In summary, BIS certification is crucial for businesses looking to sell their products in India. If you're planning to enter the Indian market, integrating BIS certification into your strategy is essential. Reach out to a BIS certification consultant today, and let us help you navigate the process to obtain your BIS certificate swiftly. Contact us now to learn more about the process and achieve BIS certification with ease!