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What is a Marketing Authorization Holder (MAH)?

JP-unique

The MAH (製造販売業者 — Seizouhanbaigyo-sha) requirement is the defining structural feature of Japan's medical device market. Unlike the EU (where the manufacturer can hold the CE marking), the US (where the manufacturer holds the 510(k) or PMA), or Australia (where the sponsor can be overseas), Japan requires every device approval or certification to be held by a Japan-domiciled entity. Overseas manufacturers cannot hold Japanese device approvals directly.

The MAH is the entity in Japan that:

  • Holds the Shonin (approval), Ninsho (certification), or Todokede (notification) — the legal right to market the device in Japan
  • Bears primary regulatory responsibility under the PMD Act for the device's safety, quality, and efficacy throughout its market life
  • Must hold an MAH business licence issued by the relevant prefectural government or MHLW

The MAH requirement is established in PMD Act Article 13 (manufacturing business licence) and Article 14 (approval application requirements). Only an entity holding a valid MAH business licence can apply for or hold a Shonin or Ninsho.

What the MAH does​

The MAH is responsible for:

  1. Preparing and submitting pre-market applications (Shonin, Ninsho, or Todokede)
  2. Maintaining the approval or certification through ongoing compliance
  3. Operating the post-market surveillance programme under GPSP
  4. Filing adverse event reports to MHLW
  5. Managing recalls and field safety corrective actions
  6. Controlling labelling in Japan and ensuring it matches the approved content
  7. Filing change applications (Ichibu Henko) before significant device changes
  8. Overseeing the quality management of contracted manufacturers (MO 169)

The Japan domicile requirement​

The MAH must have its principal office in Japan. "Principal office" means a registered business address with genuine business operations — a postal address alone is insufficient. The MAH must be able to receive MHLW communications, respond to PMDA queries, and execute regulatory obligations from this address.

For most overseas manufacturers, establishing a Japan-based MAH means either:

  • Setting up a Japan subsidiary (direct investment), or
  • Contracting with an existing Japan-based specialist regulatory service company (Kannin MAH)

What the MAH is not​

The MAH is not merely a representative or regulatory agent in the EU/Australian sense. The MAH is the legal holder of the regulatory authorisation with full regulatory responsibility. MHLW treats the MAH as the accountable entity — not the overseas manufacturer. If there is a recall or adverse event investigation, MHLW communicates with the MAH, not the manufacturer.