Insights on Selecting the Right Testing Lab

In the intricate journey of Device Development and regulatory registrations, the significance of Preclinical Efficacy, Safety, Biocompatibility, Chemical Characterization Studies, and essential documentations like Biological Evaluation Plans and Reports, and Toxicological Risk Assessment cannot be overstated. Regulatory approvals from esteemed entities such as USFDA, EU CE marking, and local regulatory bodies demand meticulous test reports, ensuring the utmost safety and effectiveness of the device or material.

Biocompatibility test results, in particular, hold a significant role in obtaining approval for medical devices. It is imperative for manufacturers to meticulously choose a testing laboratory that complies with the required quality systems.

Standards Recognition:

Both the EU and USFDA acknowledge ISO 10993-1:2018(E) for selecting Biocompatibility tests based on specific criteria. Following the issuance of the USFDA guidance document in June 2016, manufacturers can submit the same reports to the EU for CE marking and the FDA (with additional tests required by the FDA), if conducted in compliance with Good Laboratory Practices (GLP) at GLP certified Labs.

Japan-Specific Protocol:

Despite Japan's active involvement in framing ISO standards, a separate protocol for biocompatibility testing for submission to Japan has been established. Manufacturers can refer to the "Basic Principles of Biological Safety Evaluation Required for Application for Approval to Manufacture (Import) Medical Devices" from the Ministry of Health, Labor, and Welfare.

Choosing the Right Laboratory:

While price and turnaround time are common considerations for selecting labs, the quality of reports is contingent on various factors such as:

• Quality certifications of the laboratory (GLP certificate, AAALAC, and USFDA, etc.).
• Expertise in Biocompatibility testing.
• Qualifications and experience of Study Directors handling studies.
• State of the art Facilities and modern infrastructure.
• Compliance with national and international guidelines and standards.
• In-depth understanding of selection tests and test methods for devices.
• Careful selection of extraction solvents and conditions.

Importance of OECD GLP Certified Labs:

To comply with EU, USFDA, and other regulatory agencies, it is recommended to choose a CRO certified for OECD GLP. Opting for labs audited by USFDA ensures global regulatory compliance and helps avoid repeat testing.

Vivo Bio Tech Limited aligns with all these requirements, holding certifications for OECD GLP and AAALAC International, and compliance with various local apex bodies. With a decade of expertise in biocompatibility testing, Vipragen Biosciences ensures a thorough understanding of global regulatory requirements.

For any further information or assistance with biocompatibility testing requirements, please feel free to contact us at sridhar.m@vivobio.com.