Medical Devices under the PMD Act

Overview

Medical devices are products intended to be used for the diagnosis, treatment or prevention of disease, or to affect the structure or function of the human body. In Japan, medical devices are regulated under the PMD Act, and their quality, efficacy and safety are subject to regulatory control.

This article focuses on medical devices for human use. Veterinary or animal-use medical devices may involve different regulatory considerations and should be checked separately.

For import practice, the key point is that a product sold overseas as a healthcare device, beauty device, measuring device or testing-related product may still be treated as a medical device in Japan. The product name alone is not enough. Intended use, structure, performance, labeling, manuals, website descriptions and advertising claims must be checked.

Why Classification Matters

Medical devices are one of the areas where classification under the PMD Act is especially important. The required procedure depends on the product type, risk class, intended use and how the product will be placed on the Japanese market.

Medical devices in Japan are classified into four risk classes: Class I, Class II, Class III and Class IV. 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. The required procedure depends on the class and category of the specific product.

When a product is imported for sale, lease or commercial use in Japan, the issue is not only whether the cargo can physically clear customs. The importer must also confirm whether the Japan-side regulatory structure is in place, including the relevant licence, registration, approval, certification or notification.

Products That May Be Medical Devices

Products that may fall within the scope of medical devices include not only equipment used in hospitals, but also household, health management and beauty-related products where medical functions or medical claims are involved.

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

The boundary between beauty products, cosmetics, wellness goods and medical devices should be checked carefully. A product may be treated as a cosmetic or general consumer product if it only makes cosmetic or appearance-related claims, but it may fall into medical device regulation if it claims diagnosis, treatment, prevention or functional effects on the body.

Main Points to Check

• Is the product intended for diagnosis, treatment or prevention of disease?
• Does the product claim to affect the structure or function of the human body?
• Is the product classified as Class I, II, III or IV in Japan?
• Is notification, certification or approval required for the specific product?
• Is a Japanese Marketing Authorization Holder involved?
• Is manufacturing establishment registration or foreign manufacturer-related registration required?
• Do labels, manuals, catalogues, EC pages or advertisements contain medical claims?
• Is the import for commercial sale, lease or business use, rather than personal use?

Import and Sale in Japan

For commercial import and sale of medical devices in Japan, the Japan-side business operator must confirm the required PMD Act framework before import or market placement. This may include a medical device marketing authorization holder licence, manufacturing establishment registration, foreign manufacturer-related registration and product-level notification, certification or approval.

The required procedure depends on the device classification, risk class, intended purpose, sales route and whether storage, labeling, repacking or other operations are carried out in Japan. Overseas suppliers and origin-side forwarders should understand that the Japanese importer or Marketing Authorization Holder usually handles the regulatory procedure, but overseas product descriptions and sales materials can still affect the assessment in Japan.

Personal Import and Business Import

Personal import and business import should be clearly distinguished. A product imported for an individual’s own 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

• The invoice describes the product only as a “device,” “machine,” “health equipment” or “beauty device.”
• The overseas supplier treats the product as a general consumer item, while the Japanese sales material suggests medical use.
• The product description includes diagnosis, treatment or prevention claims.
• Measurement results are intended to be used for health or medical judgment.
• The product claims effects through electrical stimulation, heat, light, ultrasound or similar actions on the body.
• The product is marketed for hospitals, clinics, nursing care facilities or therapeutic use.
• The shipment is arranged before the Japan-side regulatory status has been confirmed.

Practical Notes for Shipments to Japan

For shipments to Japan, the safest approach is not to decide medical device status based only on the invoice description, HS code or overseas product category. When the product has health, diagnostic, therapeutic, measuring, body-function or beauty-related features, the Japanese importer should confirm the PMD Act position before shipment.

In practice, the Japan-side importer or Marketing Authorization Holder usually handles the regulatory confirmation. However, overseas suppliers and origin-side forwarders should understand that product descriptions, catalogues, manuals and website claims prepared outside Japan can still affect the regulatory assessment in Japan.

This is especially important because Japanese practice may be conservative. Even where a product is freely sold overseas, Japanese customs clearance, domestic distribution and advertising review may require a stricter classification check.

Relationship with Logistics and Customs

Forwarders and customs brokers are not expected to make final PMD Act classification decisions. However, they should notice warning signs and ask the importer to confirm the regulatory position when the cargo description or sales material suggests possible medical device use.

Generic descriptions such as “machine,” “device,” “health equipment,” “beauty device” or “testing equipment” do not confirm that the product is outside the scope of the PMD Act. If the product is for commercial distribution in Japan, the importer should confirm whether notification, certification, approval, licence or registration is required before shipment.

For origin-side logistics offices, this is a practical document-control issue. The invoice, packing list, product brochure, manual and website description should not contradict the intended regulatory treatment in Japan. If medical claims appear in one document but not another, the shipment may face questions or delays.

Key Takeaway

Medical devices can create serious problems in Japan if the PMD Act classification is missed. Importers and logistics parties should not rely only on the product name. Intended use, performance, risk class, labeling, advertising claims and sales purpose must be reviewed before shipment, together with the need for licence, registration, approval, certification or notification.