IVD Regulatory Consultants

IVD Regulatory Consultants

IVD regulatory consultants to help with your IVD Registration

The IMDRF (Global Harmonisation Task Force) and many country-specific regulations have separate classification systems for IVD devices, typically based on risk to the patient. It can be a confusing and difficult exercise to determine which classification your device falls into within each different set of regulations. Using our extensive experience and regulatory contacts, our IVD regulatory consultants can help you work out the right classification for your IVD and prepare the dossiers that need to be submitted to the regulatory bodies.



Low Individual Risk and Low Public Health Risk

Clinical Chemistry Analyser, prepared selective culture media


Moderate Individual Risk and/or Low Public Health Risk

Vitamin B12, Pregnancy self testing,
Anti-Nuclear Antibody, Urine test strips


High Individual Risk and/or Moderate Public Health Risk

Blood glucose self testing, HLA typing,
PSA screening, Rubella


High Individual Risk and High Public Health Risk

HIV Blood donor screening, HIV Blood diagnostic

Figure 1. IMDRF (old) GHTF classifications

IVD Manufacturing Licences

We can assist in setting up the systems needed to get the appropriate certifications from regulatory bodies. Typically, an ISO 13485 (similar to the USA CFR 21 Part 820) compliance Quality Management System (QMS) is required for IVDs. We can help you write one from scratch or fix the one you already have.

Compliance Problems

If you are preparing or recovering from a regulatory audit, we can help you determine your level of compliance and/or solve specific GMP compliance issues. This may include conducting a mock audit or reviewing the findings from a regulatory audit to determine the best course of action.

International Medical Device Regulators Forum (IMDRF)

Welcome to our informational section on the International Medical Device Regulators Forum (IMDRF) as Medical Devices and IVD Regulatory Consultants it’s important to get manufacturers or sponsors a sense of the global regulatory landscape.

IVD Regulatory Consultants

What is the IMDRF?

The International Medical Device Regulators Forum (IMDRF) is a voluntary group of medical device regulators from around the world. Originally established in 2011, the IMDRF was created to build on the foundational work of the Global Harmonization Task Force on Medical Devices (GHTF), a similar initiative that operated from 1992 to 2012. The IMDRF is composed of members from various countries, including the United States, Canada, Europe, Australia, Japan, China, Brazil, and Russia.

The primary goal of the IMDRF is to accelerate international medical device regulatory harmonization and convergence. In simpler terms, it seeks to create a more streamlined and consistent global framework for the regulation of medical devices, thereby ensuring higher safety and performance standards while facilitating innovation and accessibility in the field.

What are the Objectives of the IMDRF?

The IMDRF pursues several key objectives to support its overarching mission of promoting global harmonization in medical device regulation. These include:

1. Encouraging Convergence of Regulatory Practices: The IMDRF aims to foster alignment in the principles and practices of medical device regulation among its member nations. This involves the development and promotion of globally harmonized documents, standards, and guides for regulation.

2. Enhancing Knowledge Exchange: The IMDRF facilitates the exchange of information and regulatory practices among member countries. This includes the dissemination of regulatory guidelines, standards, and other related documents.

3. Supporting Innovation and Advancement: By promoting consistent and clear regulatory guidelines, the IMDRF supports innovation and technological advancement in the medical device industry. This environment allows for more efficient and effective product development and market access processes.

4. Ensuring Safety and Performance of Medical Devices: The IMDRF’s efforts contribute to improving the safety and performance of medical devices, ultimately benefiting patients and healthcare systems worldwide. The harmonized regulations help to ensure that medical devices entering the market are safe and effective.

5. Facilitating Trade: By creating a uniform regulatory framework for medical devices, the IMDRF aids in reducing barriers to international trade, making it easier for manufacturers to navigate regulatory processes and bringing medical innovations to patients more quickly.

6. Strengthening Cooperation Among Regulatory Authorities: Through the IMDRF, regulatory authorities can collaborate more effectively, share best practices, and work together to address common challenges in medical device regulation.

In conclusion, the International Medical Device Regulators Forum plays an essential role in shaping the global landscape for medical device regulation. It strives to promote a consistent and efficient regulatory environment, ultimately benefiting manufacturers, healthcare providers, and patients worldwide. We hope this page has provided you with a comprehensive understanding of the IMDRF and its objectives. Feel free to explore the rest of our site for more insights into the world of medical device regulation or ask one of our IVD Regulatory consultants for help.

More Information:

Please contact us at one of our offices around the world to discuss your needs or to obtain a quote.