A country-by-country IVD matrix comparing whether diagnostics share the medical-device route, sit under an independent framework, or are treated as pharmaceuticals, together with the classification system and IVD-specific filing constraints stated on each country page.
An IVD is not simply “one subtype of medical device” everywhere. Some markets use the medical-device registration route with IVD-specific classification rules, others place IVDs under a separate regulatory framework, and Japan legally classifies them as pharmaceuticals. Before reusing a multi-country dossier, first determine which track each target market puts the IVD on.
A market appears below only when its linked English country page contains a substantive, dedicated IVD passage that supports the table fields. Every regulatory-track, classification, and special-requirement statement is limited to that passage (plus the Japan page’s express legal-classification statement). 【待核验】 is retained wherever the source passage flags an unresolved point.
| Country / market | IVD regulatory track | IVD classification system | IVD-specific requirement or constraint |
|---|---|---|---|
| European Union | Independent framework — EU IVDR 2017/746, separate from EU MDR 2017/745 | IVDR Class A–D | Class A is self-declared; Class B requires a Notified Body quality-system audit; Class C adds technical-documentation review; Class D requires full Notified Body review plus EU reference-laboratory consultation. |
| United Kingdom | Same medical-device regime, with a distinct IVD classification table | Class A–D | Class A is self-declared; Classes B–D require CAB review, with full CAB review for Classes C/D. The IVD classification system is being updated as part of the UK MDR 2002 revision. |
| Canada | Same Medical Devices Regulations route, plus IVD-specific requirements | The IVD passage specifically identifies Class III/IV as high risk | Class III/IV IVDs require accuracy, precision, specificity, and sensitivity data; certain high-risk IVDs require performance validation conducted in, or extrapolatable to, the Canadian population. |
| United States | Same device regime, with separate IVD classification logic | Product-specific logic under 21 CFR Parts 862–864 | The country page states that analytical-performance standards and reference-material requirements are more stringent for IVDs. |
| Australia | Independent IVD classification rules within ARTG registration | Class 1–4 | Class 3/4 IVDs require full technical review, and performance data must include validation in, or extrapolatable to, the Australian population. |
| Argentina | Independent IVD framework — Disposición ANMAT 2674/1999 | Categorías A–D | Non-cold-chain Categoría A/B IVDs with qualifying reference-country authorization can use the Decreto 892/25 sworn-declaration route and skip local testing; cold-chain IVDs are excluded. A mandatory professional-use legend applies. |
| Brazil | Independent framework — RDC 830/2023, the IVD-specific counterpart to RDC 751/2022 | Class I–IV; Notificação for I/II and Registro for III/IV | The dossier adds performance-evaluation and reference-interval studies; Class III/IV sites are subject to BGMP, and the AREE reliance route extends to Class III/IV IVD primary registrations. |
| Colombia | Independent framework — Decreto 3770 de 2004, separate from the general-device decree | Categoría I/II/III | Categoría I/II receive automatic registro sanitario; Categoría III requires prior specialized-commission approval and complete performance-evaluation data. 【待核验：Categoría I/II/III IVD 专属审评时限（自动注册的具体工作日数）本轮未能独立核实，建议提交前直接向 INVIMA 或 Decreto 3770/2004 官方文本核对】 |
| Mexico | Same RIS Article 83 route, with a parallel IVD classification track | Parallel classification under the general RIS/NOM framework; same Aviso/Registro split by class | Performance-evaluation and reference-interval studies are added to the dossier. 【待核验：本轮未能独立核实是否存在专门针对体外诊断试剂的独立 NOM 标准或分类附件（类似巴西 RDC 830/2023 的独立 IVD 法规）；现有信息显示墨西哥体外诊断试剂目前仍并入 RIS 第 83 条通用框架，建议以 COFEPRIS 官方最新指南核验】 |
| China | Independent IVD classification and filing measures — NMPA Order No. 48 | Class I–III under the IVD-specific catalogue | Class III IVDs generally require a China-based clinical study; exempt products use predicate-methodology or reference-measurement comparison studies. The dossier also adds reference intervals, sample stability, and applicable comparator studies. |
| India | Independent parallel rule-set — In Vitro Diagnostics Medical Devices Rules 2017 | Class A–D, using IVD-specific risk criteria | New Class B–D IVDs generally need India-specific clinical evaluation even with overseas approval, and Class C/D IVDs are typically subject to BIS/NABL local-testing expectations. 【待核验：IVD临床评价豁免的具体尺度未在本轮独立核实,建议逐案与CDSCO或代理确认】 |
| Indonesia | Same medical-device track, with IVD-specific classification rules | Class A–D, AMDD/GHTF-aligned | Certain IVD categories require recognized reference-country approval before filing. HIV reagents and test kits additionally require performance reports from Indonesia’s National Reference Laboratory Hospital (RSCM), regardless of foreign approval. |
| Japan | Pharmaceutical track — legally classified as in vitro diagnostic pharmaceuticals under the PMD Act | Parallel Class I–IV | Class I uses Todokede; Class II with a Certification Standard uses RCB-reviewed Ninsho; Class II without a standard and Class III/IV use PMDA-reviewed, MHLW-approved Shonin. Companion diagnostics are coordinated with the paired therapeutic review. |
| Malaysia | Same Registration-via-CAB route, with IVD-specific guidance MDA/GD/0001 | Class A–D | Class A uses the simplified route; Classes B/C/D use Full Conformity Assessment or the Verification Route through MeDC@St. 【待核验：Malaysia 对特定高风险 IVD 品类（如 HIV/HBV/HCV 筛查）是否存在类似泰国的强制本地检测要求，本轮未能独立核实，建议向 MDA 或本地 CAB 直接确认】 |
| Philippines⚑ | Independent IVD framework in transition, with parallel CIVDN/CIVDR certificates | AMDD Class A–D | Lower-risk devices use CIVDN and higher-risk devices use CIVDR. Class B/C/D applications are reported to need performance-evaluation endorsement by an FDA-accredited Philippine laboratory. 【待核验：具体认可实验室清单及适用产品范围建议直接向 CDRRHR 核实】 The FDC 2022-008 ASEAN abridged pathway explicitly excludes IVDs; reported IVD timelines also remain 【待核验】. |
| Singapore | Same SHARE registration and evaluation-route framework, with IVD-specific GN-14 rules | Class A–D under GN-14’s IVD-specific 16-rule scheme | Full/Abridged/Expedited/Immediate routes remain available, and qualifying variants may be grouped as an IVD Cluster; high-risk infectious-disease IVDs are most likely to require full technical review. 【待核验：IVD 专属评审时限是否与同类别通用器械完全一致，本轮未能独立核实 IVD 专属 TAT 表，建议提交前向 HSA 直接核实】 |
| South Korea | Same GHTF-aligned device track, with IVD-specific predicate and evidence criteria | Class I–IV, branching further by predicate / substantial-equivalence status | Foreign clinical or analytical data for companion diagnostics and comparable products needs Korean-population bridging evidence where population factors may affect performance; the KLH must also file monthly IVD supply reports. |
| Taiwan | Same medical-device listing / registration route, with IVD-specific technical criteria | Class I/II/III | The dossier adds analytical-performance evaluation, reference-standard or calibrator documentation, and stability data. The same qualifying FDA/CE/PMDA acceleration logic applies. |
| Thailand | Same device route, with IVD-specific classification factors and extra requirements | Class 1–4; Listing / Notification / Licensing by class | HIV and COVID-19 test kits and reagents require a performance-test certificate from a laboratory in Thailand regardless of reference-country approval. CE IVDR can support, but does not replace, the local technical dossier. |
| Vietnam⚑ | Same notification / marketing-authorization mechanics, with a separate WHO-based IVD classification scheme | WHO IVD-classification-based low-to-high risk scheme, distinct from the general Type A–D hardware scheme | CE IVDR and FDA IVD clearances reduce deficiency-query volume but do not create a formal fast track. Whether high-risk IVDs carry a distinct local-testing requirement is 【待核验】 and Vietnamese kit labels and inserts are required. |
| Iran⚑ | Reportedly the same general-licence / exclusion-list device track | GHTF-aligned Class A–D; no IVD-specific guidance was independently located 【待核验】 | Cold-chain, reagent continuity, and calibration/QC support are practical entry constraints. 【待核验 — whether Iran imposes mandatory local testing or validation requirements for specific high-risk IVD categories (e.g., infectious-disease screening assays) was not confirmed in sources available this round.】 |
| Saudi Arabia | Same MDMA / Abridged / Full Review route, with independent IVD classification rules | Independent SFDA IVD rules; confirm through a PRISM classification query | Certain infectious-disease IVDs need additional SFDA approval; Class C/D files require analytical and clinical performance evidence. 【待核验：本轮未能独立核实自测 IVD 专项要求的具体条款细节，建议提交前向 SFDA 直接核实】 【待核验：IVD 专属审评时限是否与通用器械完全一致，本轮未能独立核实 IVD 专属 TAT 是否存在差异，建议提交前向 SFDA/SAR 直接核实。】 |
These rules reorganize only what the country-page IVD passages state; they do not add a universal IVD pathway.
The same apparent A–D or I–IV scale can sit inside very different legal structures: a shared device route, a dedicated IVD regulation, or Japan’s pharmaceutical track. Reuse the dossier only after both the legal track and local IVD class are fixed.
Argentina can waive local testing for qualifying non-cold-chain A/B IVDs; Indonesia makes reference approval a filing precondition for some IVDs; the Philippines excludes IVDs from its cited ASEAN abridged route; Thailand keeps specified local performance testing regardless of foreign approval; Vietnam treats CE/FDA as query-reducing evidence, not a formal fast track.
Indonesia’s RSCM testing, reported Philippine accredited-laboratory endorsement, Thailand’s in-country performance certificate, and India’s local testing or clinical-evaluation expectations can sit on top of the filing itself. The permitted IVD passages do not establish a universal batch-release rule, so do not import a general-device batch-release assumption into an IVD plan unless the target country’s IVD section states it.
Next, compare what each market does with reference approvals, then check the general timeline and fee matrix and open the linked country pages for the full filing context.
