What are the differences in IVD diagnostic devices?

Once the Covid-19 pandemic is under control, a series of other infectious diseases such as dengue fever, influenza A, and monkeypox simultaneously break out. The quality of test kits and medical devices becomes a concern for many people. However, in reality, not many people know how to choose a standardized test kit based on various criteria such as IVD, CE-IVD, FDA, TCVN, and so on.

To help people gain a better understanding, we had a conversation with Dr. Dương Ngọc Cường – an expert in laboratory quality management. He has previously worked with the Laboratory Response Network at the US CDC, the USAID Infectious Disease Detection and Surveillance Project, and has experience in building and operating IVD medical device manufacturing facilities.

Reporter: On the market and in many regulations of the Ministry of Health regarding medical device management, I have noticed references to the in vitro diagnostic (IVD) medical device standard. So, what exactly is IVD, sir?

Ph.D. Dương Ngoc Cuong: Simply put, in vitro diagnostic (IVD) medical devices are substances, instruments, and systems used to diagnose diseases, including infectious diseases, to determine the health status of the diagnosed individual for the purpose of treatment, care, mitigation, or prevention of disease-related consequences. These tests are typically conducted outside the body, in test tubes or devices, and can be performed in laboratories, healthcare facilities, or even at home.

The process of licensing an IVD product that complies with the standards and regulations of a country or territory (e.g., CE-IVD) involves the examination and assessment of its conformity and quality according to the regulations of that specific country or territory. The product, once certified, is commonly referred to as an “IVD certified product” for diagnostic testing purposes.

Depending on the intended use, diagnostic testing products may have designations such as RUO (Research Use Only) for research purposes and IVD (In Vitro Diagnostic) for diagnostic testing.

Reporter: Currently, some medical devices, test kits, and vaccines are advertised as “CE-IVD certified,” “FDA-approved,” “WHO licensed,” and so on. What are the differences between these standards, sir?

Ph.D. Dương Ngoc Cuong: In each country and territory, there are regulations for the licensing of medical devices according to their own standards and requirements. The majority of these regulations consider safety and may have different requirements for the effectiveness of medical devices in specific fields. For example, in the United States, evaluation standards set by the Food and Drug Administration (FDA) are typically applied. In Europe, there are separate standards, such as the previous Council Directive 98/79/EC and the current Regulation 2017/746 on in vitro diagnostic medical devices. Australia has standards set by the Therapeutic Goods Administration (TGA), and Japan has standards established by the Pharmaceuticals and Medical Devices Agency (PMDA).

The World Health Organization (WHO) does not directly license medical devices in each country or territory, but it has prequalification programs for the safety, quality, and suitability of drugs or medical devices. These programs aim to provide guidance to United Nations agencies and WHO member states in procurement processes. The prequalification requirements are stringent and require manufacturing facilities to comply with various regulations and standards such as ISO 13485 and/or GMP. The products also need to meet IVD standards in specific countries and territories. Additionally, WHO maintains an Emergency Use Listing (EUL) for urgently recommended use of drugs, vaccines, biological products, and medical devices in global emergency situations, such as the recent Covid-19 pandemic.

Therefore, it can be said that certification and recognition of IVD devices by each country and territory are prerequisites for these devices to be allowed to be marketed. Depending on the level of requirements and the recognition of each standard, countries will permit the circulation of these devices. Currently, the recognition of CE-IVD (Europe) or FDA (United States) is prestigious enough that other countries may refer to them in order to expedite the issuance of marketing authorizations for devices certified by these two organizations.

Reporter: How is the licensing of IVD devices in Vietnam, sir?

Ph.D. Dương Ngoc Cuong: Normally, the approval process for products to meet standards can be quite lengthy. For example, if the World Health Organization (WHO) conducts an emergency review (such as in the case of SARS-CoV-2 diagnostic tests), it can take several months.

Vietnam also has its own quality standards and regulations for IVD products. Most recently, the government issued Decree 98/NĐ-CP on the management of medical devices, and Circular 05/TT-BYT provides detailed guidelines for the implementation of certain provisions of Decree 98. However, to obtain certification and approval for circulation as an IVD product, the product must undergo clinical trials on a large number of samples from authorized clinical trial facilities.

In the process of international integration, Vietnam has accepted medical devices that have been granted free circulation certificates by countries and organizations such as FDA (USA), TGA (Australia), Health Canada, PMDA, the national health agencies of Japan (MHLW), South Korea (MFDS), China (NMPA), and EU member states under Regulation 2017/746. Medical devices that have been licensed in these countries and organizations no longer require quality assessments by the competent authorities in Vietnam.

Reporter: In reality, not all products on the market are granted licenses by reputable organizations. Normal individuals during the process of seeking medical treatment may find it difficult to know or control whether the products they use meet the standards or not. Therefore, IVD certified tests should be given attention and used in which cases, sir?

Ph.D. Dương Ngoc Cuong: Medical devices that meet IVD certification standards are crucial in diagnostic testing, particularly for infectious diseases (with high-risk levels) such as HIV, HBV, and genetic-related tests in obstetrics, cancer, etc. The use of IVD certified products ensures that these products have undergone rigorous scrutiny for safety and effectiveness in their respective testing procedures.

At the Vietnam-France Obstetrics Conference, Associate Professor Vu Ba Quyet, Vice Chairman of the Vietnam Association of Obstetrics and Gynecology (VAGO), also shared that in recent years, molecular biology, particularly next-generation sequencing technology, has made significant advancements and has been widely applied in obstetrics and reproductive support. Previously, pregnant mothers were familiar with biochemical screening tests such as the Double Test and Triple Test, and if there were any suspicions of abnormalities, invasive interventions like amniocentesis or chorionic villus sampling were required. Now, there is a non-invasive prenatal screening test (NIPT) based on genomic sequencing technology, which can detect chromosomal abnormalities simply by taking a blood sample from the mother at around the 10th week of pregnancy. Although this is a prenatal screening test, we always guide patients to seek efficient, safe, and highly accurate tests that meet international standards. Having reliable test results significantly reduces the burden of counseling and caring for pregnant women.