Medical Device Marketing Authorization Holder Licence

Overview

A Medical Device Marketing Authorization Holder Licence is the PMD Act licence required for a Japan-side business operator that takes legal responsibility for placing medical devices on the Japanese market. In this context, “marketing authorization” means releasing a medical device manufactured or imported into Japan for domestic distribution.

For import practice, the key issue is not only whether the cargo can clear customs. When overseas-made medical devices are sold in Japan, it is necessary to confirm who will act as the Japan-side responsible party, whether manufacturing establishment registration or Foreign Manufacturer Registration is required, and whether product-level notification, certification or approval is needed.

Role of the Marketing Authorization Holder

The Marketing Authorization Holder is the responsible party for releasing the medical device onto the Japanese market. This role is different from a simple importer, distributor, sales agent or logistics provider.

The Marketing Authorization Holder is responsible for regulatory control, quality management, safety management, post-market handling and related obligations. The Marketing Authorization Holder is also generally required to maintain a quality management system conforming to applicable Japanese standards. Even where the product is manufactured overseas, the Japan-side regulatory responsibility must be clearly identified before the product is placed on the Japanese market.

Import and Sale in Japan

When medical devices are imported for commercial sale, lease, distribution, demonstration, clinic use or other business purposes in Japan, the Japan-side regulatory framework must be checked before shipment or market placement.

Depending on the product and business model, this may involve a Medical Device Marketing Authorization Holder Licence, manufacturing establishment registration, Foreign Manufacturer Registration and product-level notification, certification or approval.

Manufacturing establishment registration concerns facilities in Japan that perform storage, labeling, packaging, relabeling or other regulated operations. Foreign Manufacturer Registration concerns overseas manufacturing sites involved in the product. These two points should not be confused.

The required procedure depends on the medical device class, risk level, intended use, sales route and whether any storage, labeling, packaging, relabeling or other regulated operation is carried out in Japan.

Foreign Manufacturer Registration

Foreign Manufacturer Registration is a registration of the overseas manufacturing site under the PMD Act. It is relevant when an overseas site manufactures medical devices that will be placed on the Japanese market.

In practice, this registration is generally coordinated by the Japan-side Marketing Authorization Holder or the Japan-side party responsible for the product procedure. It is not simply a logistics task handled by the forwarder. However, overseas suppliers should be prepared to provide site information, manufacturing details, quality-related information and supporting documents when requested by the Japan-side party.

For origin-side forwarders and overseas suppliers, the practical point is that the identity and address of the actual manufacturing site may matter. If the invoice, packing list, catalogue or shipping documents do not match the manufacturer information used for Japanese regulatory purposes, the Japanese importer may need clarification before shipment or before market placement.

Device Classification and Product Procedures

Medical devices in Japan are classified into Class I, Class II, Class III and Class IV according to risk. The product-level procedure depends on the class and applicable standards.

Class I devices are generally subject to notification. Class II devices may require certification by a registered certification body if certification standards exist, or approval if they do not. Class III devices generally require marketing approval, though some may be subject to certification depending on the applicable standards. Class IV devices generally require marketing approval.

For this reason, having a Japan-side business operator is not enough by itself. The product-level procedure for each device must also be confirmed.

Products That May Be Covered

The licence issue arises when the product is a medical device under the PMD Act. Products used in medical settings are obvious examples, but household, health management and beauty-related products may also become medical devices depending on their intended use, labeling or claims.

• Blood pressure monitors, thermometers and pulse oximeters
• Contact lenses and hearing aids
• Syringes, catheters and surgical instruments
• Testing equipment, measuring equipment and diagnostic-related devices
• Treatment devices and rehabilitation equipment
• Household medical devices
• Beauty or wellness devices that claim medical, therapeutic or body-function effects

Main Points to Check

• Is the product a medical device under the PMD Act?
• Is the import for commercial sale, lease, distribution or business use?
• Who will act as the Japan-side Marketing Authorization Holder?
• Does the Japan-side operator hold the appropriate Medical Device Marketing Authorization Holder Licence?
• Is manufacturing establishment registration required for any Japan-side facility?
• Is Foreign Manufacturer Registration required for the overseas manufacturing site?
• Is product-level notification, certification or approval required?
• Are labeling, manuals, catalogues and advertisements consistent with the approved, certified or notified scope?

Personal Import and Business Import

Personal import and business import should be clearly distinguished. A product imported by an individual for personal use is different from a product imported for sale, lease, distribution, demonstration, clinic use or other business purposes.

However, personal import does not automatically remove all regulatory concerns. Medical devices may still be subject to quantity limits, product restrictions or other conditions. If the shipment is connected with commercial distribution, advertising, resale or use by a business operator in Japan, it should be treated as a business import issue and checked under the PMD Act before shipment.

Common Problems

• An overseas manufacturer assumes that a product sold abroad can be sold in Japan without Japan-side regulatory preparation.
• The importer is unclear about whether it will act as the Marketing Authorization Holder or only as a distributor.
• A distributor tries to sell the product without confirming the MAH structure.
• The shipment is arranged before product-level notification, certification or approval has been confirmed.
• Storage, labeling, packaging or relabeling is carried out in Japan without checking manufacturing establishment registration.
• The overseas manufacturing site requires Foreign Manufacturer Registration, but this has not been arranged.
• The overseas manufacturing site shown in commercial documents does not match the regulatory information used in Japan.
• Advertising claims exceed the approved, certified or notified scope of the device.

Practical Notes for Shipments to Japan

For shipments to Japan, overseas suppliers and origin-side forwarders should not assume that customs clearance alone means that the product can be sold in Japan. Medical device import and sale require a Japan-side regulatory structure.

In practice, the Japanese importer or Marketing Authorization Holder usually handles the regulatory procedure. However, overseas product descriptions, catalogues, manuals, labels, manufacturing-site information and website claims may still affect the Japanese regulatory assessment.

Before shipment, it is useful to confirm whether the Japanese buyer has already checked the MAH licence, Japan-side manufacturing establishment registration, Foreign Manufacturer Registration and product-level procedure. If these points are unclear, the shipment may face delays or post-import sales problems.

Relationship with Logistics and Customs

Forwarders and customs brokers are not expected to determine the final PMD Act status of the product. However, they should notice warning signs when the cargo is described as “medical device,” “health equipment,” “beauty device,” “measurement device,” “testing equipment” or similar wording.

For logistics purposes, this is a document-control issue. The invoice, packing list, brochure, manual, label and website description should not conflict with the Japan-side regulatory treatment. If one document suggests medical use while another describes the product as a general consumer device, the importer should be asked to confirm the regulatory position.

The same applies to manufacturing-site information. The shipper, exporter, factory and manufacturer shown in shipping documents may not always be the same entity. If the Japanese regulatory procedure depends on a specific overseas manufacturing site, the Japan-side party may need to confirm the correct manufacturer information before shipment.

Labeling and Advertising Claims

Medical device claims must stay within the approved, certified or notified scope of the product. Product pages, manuals, advertisements, social media posts and sales materials should be checked carefully.

Even where a product is intended to be treated as a general consumer product, claims relating to diagnosis, treatment, prevention or improvement of body functions may create medical device issues under the PMD Act.

Key Takeaway

A Medical Device Marketing Authorization Holder Licence is central to the import and sale of overseas-made medical devices in Japan. For business import, the responsible Japan-side operator, Japan-side manufacturing establishment registration, Foreign Manufacturer Registration and product-level notification, certification or approval should be confirmed before shipment. Customs clearance alone does not mean that the product can legally be sold in Japan.