Buy Medical Equipment in Japan

An MAH licence and the right frequency

Under Japan's PMD Act, importing a device in order to sell it counts as marketing. The importer must hold a marketing authorisation holder (MAH) licence. At the import declaration, customs asks for copies of that licence and of the model's approval, certification or notification. Power is the next check. The supply is 100 V, at 50 Hz in the east and 60 Hz in the west.

We're MediGear. Our company, registered in England and Wales, handles quotes, documents and shipping for healthcare buyers in more than 80 countries. For a Japanese order, we look for verified makers whose models hold Japanese approval or certification, or can reach you through your MAH. Then we check the points on this page before the quote reaches your engineers and buyers. A request needs nothing more than our buyers page, as there are no accounts.

National, university and private hospitals

Everyone in Japan has public medical insurance and a free choice of provider. Requests for Japan hospital equipment reach us from public hospitals in Japan, private groups and others, including:

• The National Hospital Organization, with about 140 hospitals in all 47 prefectures
• The University of Tokyo Hospital, Kyoto University Hospital and Osaka University Hospital
• National Cancer Center Hospital in Tokyo and the JIHS hospitals
• Private groups such as Tokushukai, with about 400 sites, and physiotherapy clinics
• Doctors and dentists importing up to three sets for their own patients
• Hiroshima's planned hospital of about 1,000 beds, due to open in FY2030
• MAHs, licensed sellers, repairers and veterinary practices

Japanese government procurement notices are listed on the Digital Agency's site. Quoting through it needs the unified qualification and an electronic certificate. Among public medical institutions, the NHO publishes its own tenders and also runs joint tenders for medical equipment. A clinic replacing one ultrasound unit needs none of that, only a clear quote and an MAH to bring the unit in.

The PMD Act, PMDA and Japanese labels

Devices in Japan fall under the PMD Act of 1960, which the Ministry of Health, Labour and Welfare (MHLW) runs. PMDA, the Pharmaceuticals and Medical Devices Agency, reviews products. Class I devices are notified to PMDA, and Class II and III devices are certified by a registered body where standards exist. Class IV needs MHLW approval, as PMDA's overview of device routes explains. A foreign maker markets through a Japanese MAH that it designates.

Selling or leasing X-ray, CT, MR and ultrasound units or bedside monitors needs a licence for each office, from the governor or a city mayor, renewed every six years. An MAH selling its own imports to licensed firms is exempt. Labels must be in Japanese, and package inserts can be searched on PMDA's website. A device without approval, certification or notification needs an MHLW import confirmation. A doctor or dentist may import up to three sets for their own patients. We hold no Japanese MAH or sales licence, so the regulatory side stays with your importer. The model's certificates are listed in every quote.

Japan X-ray machine rules: a 10-day notice

In Japan, we found no licence requirement to own or use diagnostic X-ray imaging equipment. Instead, the hospital or clinic manager notifies the prefectural governor within 10 days of installing a unit. Mobile and portable units count, as the Medical Care Act and MHLW's notice on medical radiation set out. The notice lists the maker, model, unit count, generator output, the shielding and the staff using it.

X-ray room walls, floor and ceiling must keep the dose outside at or below 1 mSv a week. The operating position normally sits outside the room. Radiation levels are measured once before clinical use, then at least monthly, or every six months for a fixed unit whose use and shielding stay the same. Records are kept for five years. Only physicians, dentists and radiological technologists may expose patients, and each hospital names a radiation safety lead who manages patient doses.

Japan diagnostic imaging equipment: 100 V and two frequencies

For a Japanese site, the maker must confirm:

• Voltage. Mains is 100 V, kept within 101 V plus or minus 6 V. Plugs are type A or B, so a 230 V unit needs a Japanese build.
• Frequency. Hokkaido, Tohoku and the Tokyo area run at 50 Hz, while Chubu westward and Okinawa run at 60 Hz, so name the prefecture.
• Maintenance plan. Each hospital's device safety manager plans and carries out maintenance. Ask for the service manual, and spare parts and consumables can join the first order.
• Records. A national service for sharing electronic health record data is being rolled out, so check DICOM and HL7 links for diagnostic imaging systems with your IT team.

Anything unclear goes to the maker in writing first, because a mains or frequency mismatch is hard to fix once the unit has landed.

Customs brokers, MAH papers and wood checks

The importer declares the goods at the customs office for the bonded area, usually through a customs broker licensed by the Minister of Finance. Filings go through NACCS online. Customs checks the PMD Act papers before it grants the import permit, so a file for Japan hospital supplies that are devices includes:

• An invoice and a packing list per shipment
• Bill of lading or air waybill, with certificates of origin where needed
• Permits under other laws, where they apply
• The model's approval, certification or notification number, for your MAH to present
• Japanese labels and the package insert details

Japan has applied ISPM 15 to wood packaging since April 2007. The agriculture ministry's Plant Protection Station runs the checks, as its wood packaging page explains. If untreated wood carries quarantine pests, the whole lot must be treated or destroyed, or re-exported with permission. Makers are asked to ship in heat-treated crates that carry the stamp.

Keihin, Hanshin and the typhoon months

1. Model and prefecture. Send the model, quantity and site by RFQ form or email, with the prefecture so we can check the frequency.
2. Quote and MAH route. For catalogue items it usually arrives within 48 hours, naming the certificates, lead time, port and how the unit reaches your MAH.
3. Written go-ahead. We confirm the order with the maker only after you approve it by email or letter.
4. Ports and airports. Sea freight into the Keihin ports of Tokyo and Yokohama, the Hanshin ports of Osaka and Kobe, or Nagoya and Hakata, or air freight into Narita for smaller items.

At the port or airport you nominate, your broker takes over with the import declaration, and the last leg is yours. Typhoons peak in August and September, so allow more time for summer sailings.

Japan refurbished medical equipment and single orders

Single units are welcome, and most catalogue lines can be quoted for a clinic in Sapporo that needs just one monitor, or for a group buying medical equipment in Tokyo. Orders for Japan general hospital supplies follow the same route, and labs can send a data sheet for laboratory mixers or other laboratory equipment. For larger work, see hospital setup for new buildings, and maternity teams can browse Women, Children and Neonatal. Refurbished medical imaging equipment from our refurbished range can go to Japan, as no ban turned up, but only through a Japanese MAH whose approval covers the model. Before a used device is resold, the seller must notify that model's MAH and follow its instructions, which may include an inspection. Servicing in Japan needs a repair licence.

Disclaimer

Read this as general information for Japanese buyers: it makes no offer to supply and gives no legal, regulatory or customs advice. Quotes depend on what makers can supply, and an order is agreed only in writing by both sides. Devices need a Japanese MAH and Japanese labelling, and an X-ray unit must be notified to the prefecture within 10 days of installation. Your importer handles clearance and the regulatory position, as we are not a Japanese MAH, importer or licensed seller.