Biological safety and compliance with global standards are critical when developing in-vitro diagnostic medical devices. One of the most important steps in this process is obtaining a BIS Certificate for Biological Evaluation of Invitro Diagnostic Medical Devices. Without this certification, you risk non-compliance, market restrictions, and potentially unsafe devices.

This article will address your questions about BIS certification for Biological Evaluation Of Invitro Diagnostic Medical Devices (MHD-19), explain its significance, and guide you through the process in an easy-to-understand manner.

By the end, you’ll have a clear understanding of how to secure this certification for your IVD medical devices and maintain compliance in the ever-evolving healthcare sector.

What Is BIS Certification And Why Is It Important For IVD Medical Devices?

A BIS Certificate for Biological Evaluation Of Invitro Diagnostic, issued by the Bureau of Indian Standards. It ensures your product meets prescribed safety, quality, and performance standards. For IVD medical devices, biological evaluation is critical to demonstrate that they are safe for human use and won’t cause adverse biological effects.

Without BIS certification for Medical Devices, your devices may fail to enter the market, resulting in significant setbacks. The certificate is not just a legal requirement but also a trust-building factor for your customers. Hence, we highly recommend you get BIS Certificate for your Invitro Medical Devices to stay away from any sort of legal trouble.

Who Needs BIS Certificate For Biological Evaluation Of Invitro Diagnostic?

Manufacturers and importers of Invitro diagnostic devices intended for the Indian market are required to secure BIS certification. Such as Domestic manufacturers who produce IVD devices for local or international markets, foreign manufacturers exporting IVD devices to India or importers and distributors bringing IVD devices into India.

If your business falls into one of these categories, obtaining the BIS Certificate is essential to ensure your products comply with Indian standards.

Also Read: BIS Certificate For Health Informatics

Why Is Biological Evaluation Critical For IVD Devices?

Biological evaluation ensures that your IVD device is biocompatible and does not provoke harmful biological responses. This is crucial because IVD devices may come into contact with human tissues or fluids.

Biological risks can include:

• Cytotoxicity: Damaging cells.
• Sensitization: Causing allergic reactions.
• Toxicity: Introducing harmful substances into the body.

The evaluation process follows international guidelines like ISO 10993, ensuring that the device is safe and effective for its intended use.

Process To Obtain BIS Certificate For Biological Evaluation Of In-Vitro Diagnostic Medical Devices

We have listed the step-by-step process for obtaining BIS Certification for Biological Evaluation of Invitro Diagnostic Medical Devices (MHD-19).

• Determine Applicability: Verify if your IVD device requires BIS certification under standards like IS 10993 for biological evaluation.
• Conduct Biological Testing: Perform tests such as cytotoxicity, sensitization, and toxicity in BIS-accredited laboratories to ensure biocompatibility.
• Prepare Documentation: Accurate and comprehensive documentation is essential for a successful application. Compile essential documents such as product technical files, certified test reports, ISO 13485 or QMS certifications, etc.
• Submit the Application: Apply online via the BIS portal or through an authorized office, attaching documents and paying fees.
• Undergo Testing and Inspection: BIS may review test reports, inspect facilities, or test product samples for compliance.
• Approval and Certification: If all requirements are met, BIS grants certification, allowing you to display the BIS Standard Mark.

Documents Required To Get BIS Certificate For Biological Evaluation Of Invitro Diagnostic

To obtain a BIS Certificate for Biological Evaluation of Invitro Diagnostic Medical Devices, there are several documents which are required, listed below:

• Application Form
• Product Specifications
• Test Reports
• Manufacturing Details
• QMS Certification
• Importer/Distributor Agreement
• Labels and Markings
• Declaration of Conformity
• Authorised Signatory Details

Also Read: BIS Certificate For Electromedical Diagnostic Imaging And Radiotherapy Equipment

List Of Standards For Biological Evaluation Of Invitro Diagnostic Medical Devices

This table outlines key standards of biological evaluation, safety, and testing of medical devices: