In Vitro Diagnostics under PMD Act Article 2, Paragraph 14

1. Key takeaways

In vitro diagnostic pharmaceutical products (IVDs) are classified in Japanese law as pharmaceuticals, yet their market entry routes, risk grading, and quality system requirements largely borrow from the rules for medical devices. This structure of nominal affiliation with drugs and procedural alignment with devices means that an IVD project must satisfy the manufacturing and marketing business requirements on the pharmaceutical side and the quality system conformity investigation on the device side at the same time. For Chinese IVD manufacturers entering Japan, the line most easily underestimated is exactly this dual compliance line, and budgeting for only one of its two halves is the classic first failure. The underestimate is invisible at the planning stage because neither half looks large on its own; the combined cost appears only once both work streams are running.

• IVDs are defined in statute as pharmaceutical products intended exclusively for disease diagnosis that are not applied directly to the body.
• Risk grading for IVDs runs across three classes, not four, and the route follows the class.
• The quality system obligations for devices and IVDs are codified in the same ministerial ordinance.

2. Legal basis

The provisions below define what an IVD is in Japanese law and establish the route and quality system framework that applies to it. Because the definitional provision sits in the pharmaceutical part of the act while the procedures sit in the device part, both halves must be cited.

1. PMD Act Article 2, Paragraph 14: the definition of in vitro diagnostic pharmaceuticals, namely pharmaceuticals intended exclusively for disease diagnosis and not used directly on the human or animal body.
2. PMD Act Article 23-2-5, Paragraph 1: approval by the Minister of Health, Labour and Welfare is required.
3. PMD Act Article 23-2-23, Paragraph 1: a foreign manufacturer may itself obtain certification on the premise of appointing a Japanese manufacturing and marketing business operator.
4. PMD Act Article 41, Paragraph 3: the standards established by the Minister of Health, Labour and Welfare (essential requirements); Article 42, Paragraph 2: certification standards.
5. The QMS Ordinance, the ministerial ordinance on the standards for manufacturing control and quality control for medical devices and in vitro diagnostic pharmaceuticals, MHLW Ordinance No. 169 of 2004, promulgated December 17, 2004; the title of the ordinance itself covers IVDs alongside devices.
6. The current statute: Act No. 145 of 1960 (Showa 35).

3. Expert insights

Insight one: the exclusion element in the definition is non-contact with the body.

Article 2, Paragraph 14 of the PMD Act draws the boundary between IVDs and ordinary pharmaceuticals by the element of not being used directly on the human or animal body. The judgment does not look at the origin of what is tested, since specimens of human origin still fall within the IVD category; it looks at whether the product enters the body. This single element means that specimen collection instruments and test reagents sit in different legal domains in Japan, with different route options and different quality system expectations attached to each. Product families that bundle both in one kit therefore need the boundary drawn item by item before any filing is planned.

Insight two: IVD risk grading has three classes, not four.

Publicly available PMDA material shows that IVDs are graded by risk into Classes I through III, which differs from the four-way division used for medical devices. Class III requires approval by the Minister of Health, Labour and Welfare; Class II proceeds by certification or approval depending on the existence of a certification standard; Class I enters the market by notification. Applying the device intuition that Class III equals highly controlled leads to misclassification of IVDs, and once the class is wrong, the route and the dossier follow it.

Insight three: the QMS Ordinance places devices and IVDs in one and the same ordinance.

The title of MHLW Ordinance No. 169 of 2004 lists both medical devices and in vitro diagnostic pharmaceuticals, which means that the manufacturing control and quality control standards for the two are of the same origin and the conformity investigation follows the same system. An IVD manufacturer does not need to build a second quality system, but it must demonstrate that the system covers the IVD-specific processes, such as control of reference materials and stability, rather than only the generic device processes. Reviewers will look for that coverage in the procedures and records themselves, not in the scope statement of a certificate.

4. Practical recommendations

• Qualify the product against the statutory definition first, then consult the generic name listings. The Ministry of Health, Labour and Welfare and PMDA each publish IVD generic name listings, and these listings are the starting point for both grading and route determination.
• Plan the analytical and clinical evidence within Class III or below. The organization of analytical performance evaluation and clinical performance evaluation should be designed in advance according to the target class.
• Build the quality system uniformly against the QMS Ordinance. IVD manufacturers that already operate an ISO 13485 system need only close the gap against Ordinance No. 169 of 2004; there is no need to establish a separate system.
• Assess Article 23-2-23 in parallel for overseas IVD manufacturers. As with devices, a route exists for overseas manufacturers to obtain certification themselves, but a Japanese manufacturing and marketing business operator whose license type matches the item must be appointed first.

5. Verification checklist

• □ Has the element of not touching the body directly under Article 2, Paragraph 14 of the PMD Act been confirmed for the product?
• □ Has the grading been confirmed using the IVD-specific generic name listings rather than the four-way device classification?
• □ Does the quality system cover the parts of MHLW Ordinance No. 169 of 2004 applicable to IVDs?
• □ For self-held certification by an overseas manufacturer, has the premise of Article 23-2-23, Paragraph 1 been confirmed?
• □ Have the analytical performance evaluation and the clinical performance evaluation been kept as two separate evidence sets?

Regulatory information verified as of October 29, 2026.

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, in-country representative and local testing support for the Japanese market. Our team manages PMDA submissions across Shonin/Todokede routes, coordinates J-QMS conformity, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com