BIS Certification for Medical Devices in India
BIS Standard for Medical Devices
In today’s global market, it is essential for businesses to comply with international standards to ensure the quality and safety of their products. One of the most recognized and respected certifications in India is the Bureau of Indian Standards (BIS) certification. In this blog, we will discuss the importance and benefits of BIS certification in India.
What is IS 23485 Certification?
IS 23485 is a recently released standard by the Bureau of India Standards (BIS), specifically aimed at Medical Devices. This standard concentrates on both the Quality Management System requisites and the essential Principles of Safety and Performance for Medical Devices.
With the introduction of IS 23485, BIS has established a new standard for Medical Devices. This guideline emphasizes aligning organizations with fundamental standards of Safety and Performance, in addition to the requirements for Quality Management Systems.
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What is BIS Certification?
The Bureau of Indian Standards (BIS) is the national standard body of India, established under the Bureau of Indian Standards Act, 1986. It is responsible for developing and promoting standards in various sectors, including products, services, and systems. BIS certification is a mandatory certification for certain products in India, and it is a mark of quality, safety, and reliability.
The purpose of BIS about medical devices is to maintain the healthcare system and to monitor the quality of devices being used in the medical field to ensure pertinence the devices are being used by following all the safety measures as per BIS authorization. The Ministry of Chemicals and Fertilizers, Department of Pharmaceuticals, Government of India released a list of Bureau of Indian Standards (BIS) standards applicable to medical devices on February 1, 2022. Pls Check the list here
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Is BIS Standard Mandatory for Medical Devices?
The purpose of the BIS Standards for Medical Devices Implementation is to comply with the set Indian Standards for the maintenance of required safety measures and the reduction of any occurrence of health hazards caused by defects in medical devices. It has been seen that only a few of the manufacturers have opted for BIS licenses for their products. As per rule 7 of MDR2017, product standards for medical devices and that medical devices should conform to the standards laid down by BIS from time to time.
If no relevant standard for a medical device has been laid down by BIS or notified by MoHFW, the device must conform to the standard laid down by the International Organization for Standardization (ISO) or any other pharmacopeial standards. In the case of standards that have not been specified by any of these options, the device must conform to the validated manufacturer’s standards.
Despite the fact that Rule 7 has been a part of the Indian MDR 2017, CDSCO reviewers and signatories have never required any demonstration of conformance to the Indian Standards. Recently, there has been ongoing discussion from the BIS, Department of Pharmaceuticals, calling for the strengthening of Indian standards.
How to Get BIS Certificate?
The below steps will be helpful to get the BIS certification:
- Register / Login
- Apply for the license
- Fill out the application form
- Attach necessary documents
- Submit the application form along with the requisite fees.
Importance of BIS Certification
BIS certification is essential for businesses that want to sell their products in India. It is a mandatory requirement for certain products, such as electrical goods, toys, and food products. BIS certification ensures that the products comply with Indian standards, which helps to protect consumers from substandard and unsafe products. It also helps businesses to establish trust and credibility with their customers.
Benefits of BIS Certification
- Access to the Indian Market: BIS certification is a mandatory requirement for certain products in India, and it is a prerequisite for obtaining clearances from government agencies. With BIS certification, businesses can access the Indian market and reach a wider customer base.
- Quality Assurance: BIS certification ensures that products comply with Indian standards, which helps to ensure the quality and safety of the products. This can help businesses to establish a reputation for producing high-quality products.
- Cost-effective: BIS certification can help businesses to save costs by reducing the need for multiple certifications. It is recognized by the Indian government and accepted by other countries, which can help businesses to access other markets as well.
- Competitive Advantage: BIS certification can help businesses to gain a competitive edge in the Indian market. It can help businesses to stand out from their competitors and attract more customers.
How We Help You in Getting BIS Certification?
- 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.
In a nutshell, BIS certification is an essential requirement for businesses that want to sell their products in India. If you are looking to sell your products in India, it is important to consider BIS certification as part of your strategy. Get in touch with any BIS certification consultant and get your products certified in no time. You can contact us to understand the process and to easily get the BIS certificate now. We also provide medical device consultation for Costa Rica, the UK, Oman, South Africa, Saudi Arabia, USA & Egypt.
FAQ's
What is the purpose of BIS certificate?
BIS operates a Product Certification Scheme to ensure compliance with Indian Standards. The presence of the BIS standard mark (also known as the ISI mark) on a product indicates conformity to the relevant Indian Standard.
Is BIS certification mandatory for medical devices?
All risk Class A and B medical devices will require an Import License beginning October 1, 2022. On October 1, 2022, the same requirement will apply to all risk Class C and D medical devices. BIS Standards for Medical Devices are designed to ensure that required safety measures are maintained in accordance with Indian Standards.
Which is the mandatory standard for medical device industry?
This includes standards such as ISO 13485 covering quality management systems for medical device manufacturers and ISO 14971 covering risk management for medical devices and other process-specific standards, such as those covering sterilisation.