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Borderline and Combination Products

Borderline with drugs and quasi-drugs​

Products that have both drug-like and device-like characteristics must be classified into the correct regulatory category before an application pathway is selected. Japan's PMD Act handles this through the primary mode of action principle: if the primary intended effect is achieved through pharmacological, immunological, or metabolic action, the product is a drug; if achieved through physical or mechanical means, it is a device.

Common borderline examples:

  • Drug-coated catheters — the device (catheter) is primary; drug coating may be ancillary → typically regulated as a device
  • Bone cement with antibiotic — case-by-case; MHLW has issued specific guidance
  • Diagnostic test kits — mixture of reagents and equipment regulated together as IVDs

MHLW has issued a series of notifications on specific borderline product types. For genuinely novel borderline cases, a formal MHLW or PMDA consultation is required before proceeding.

Combination products — device/drug​

Japan does not have a formal "combination product" regulatory category equivalent to the FDA. Instead, products combining a device and a drug are assigned to either the drug or device regulatory category based on primary mode of action. The secondary component (drug or device) must also meet its respective regulatory requirements.

Drug-eluting stents, for example, are regulated as medical devices (Class IV) in Japan; the drug component's inclusion is addressed within the device approval application. Pre-submission PMDA consultation is strongly recommended for any drug/device combination.

Combination products — device/regenerative medicine​

Japan has a separate regulatory category for regenerative medicine products (再生医療等製品) introduced by the 2014 PMD Act amendments. Products combining a scaffold device with living cells require evaluation under both the PMD Act device and regenerative medicine product frameworks. This is a specialised area requiring dedicated regulatory strategy.

How to request a formal classification opinion​

For products where regulatory classification is genuinely uncertain, the MAH can:

  1. Review MHLW notifications on borderline products — MHLW has published lists of classifications for many borderline types
  2. PMDA consultation — a formal paid consultation to discuss the classification before applying
  3. Written inquiry to MHLW — for cases not covered by existing guidance

PMDA's opinion from a consultation is not a legally binding determination (MHLW makes formal decisions), but it provides strong guidance and reduces risk before committing to a full application.