IVD Classification

In vitro diagnostics (体外診断用医薬品 — taiko shindan yakuzaihin, abbreviated IVD) are defined in PMD Act Article 2, Paragraph 5 and are regulated as a sub-category of medical products. They follow the same three-pathway structure as other medical devices but have IVD-specific classification criteria.

How IVDs are classified

IVD classification in Japan is based on the potential harm caused by a wrong test result, considering the disease being tested for, the severity of misdiagnosis, and the use setting (laboratory vs point of care vs self-testing).

Class	IVD examples
Class I	General laboratory reagents with no specific diagnostic claim
Class II	Blood glucose meters, pregnancy tests, common infectious disease tests (non-screening)
Class III	Clinical chemistry analysers, certain haematology systems
Class IV	HIV test kits, HTLV-I/II, HBsAg, HCV — blood screening assays; syphilis tests

Class IV IVDs are exclusively those used for blood safety screening and sexually transmitted infection diagnosis — the potential for widespread harm from false negatives justifies the highest regulatory requirement.

IVD-specific JMDN categories

IVDs have their own set of JMDN codes distinct from therapeutic medical devices. Identifying the correct JMDN code is the first step in confirming the IVD class and applicable recognised standards.

Regulatory pathway by IVD class

• Class I IVDs → Todokede with the prefectural government
• Class II IVDs with applicable recognised standard → Ninsho via RCB
• Class II IVDs without applicable standard → Shonin
• Class III and IV IVDs → Shonin via PMDA/MHLW

Performance evaluation requirements

IVDs require performance evaluation (analytical and clinical performance studies) as the core technical evidence. See Performance Evaluation (IVD) for the specific requirements.