Tokyo license permits Craif to market Japan's highest-risk device classes as its pancreatic cancer test moves toward a 2026 regulatory filing
TOKYO, September 17, 2026 - Craif Inc., a bio-AI company developing a urine analysis platform for early detection of cancer and other diseases, today announced that the Tokyo Metropolitan Government granted it a Type 1 medical device marketing authorization holder license on August 3, 2026.
Type 1 is the highest of Japan's three marketing authorization tiers and the only one that permits a company to bring highly controlled medical devices to market: Japan's Class III and Class IV, which correspond broadly to Class III under the FDA framework.
Craif was founded in 2018 and builds on microRNA, the class of regulatory molecules whose discovery was recognized with the 2024 Nobel Prize in Physiology or Medicine. Its urinary microRNA assay for detecting pancreatic cancer from early to late stages was published in 2024 in eClinicalMedicine, a Lancet-family journal. In Japan, the company's urine-based cancer risk test miSignal has been used for more than 110,000 tests and is offered through more than 2,500 medical institutions and 4,500 pharmacies. miSignal is a risk assessment test and is not an approved medical device. The pancreatic cancer diagnostic aid program described here is a separate, regulated product that has not yet been approved.
What a Type 1 license means
Under Japan's Pharmaceuticals and Medical Devices Act, a company that wants to place a medical device on the Japanese market must hold a marketing authorization holder license, and those licenses are tiered by the risk class of the devices they cover. Type 1 covers highly controlled medical devices (kodo kanri iryo kiki), Japan's Class III and Class IV, which correspond broadly to Class III in the United States. Type 2 covers the controlled class and Type 3 covers the general class. Type 1 is the broadest of the three, and a holder may market devices in the lower risk classes as well.
Why the license was granted
Craif built out a management system designed to meet Japan's quality management system requirements for medical devices (the QMS Ordinance) and its post-marketing safety management requirements (the GVP Ordinance), with the eventual rollout of a pancreatic cancer diagnostic aid program in clinical settings in view. The license was issued after an administrative review confirmed that Craif's quality and safety management systems satisfy the legal requirements for a marketing authorization holder.
Where the pancreatic cancer program stands
Craif is developing a medical device program that combines urinary microRNA and other markers with AI analysis to support the diagnosis of pancreatic cancer, a disease that is notoriously hard to catch early. The pivotal trial, run in partnership with 12 sites across Japan, has completed case registration and sample collection. Performance evaluation is now underway.
The company is targeting a medical device marketing approval application in 2026 and regulatory approval in 2027. It intends to use the marketing authorization license as the basis for further building out its marketing and distribution organization.
Notes
Under Japan's Pharmaceuticals and Medical Devices Act, a medical device program is software that has a medical device purpose, meaning it contributes to the diagnosis, treatment or prevention of disease, and that could affect the life or health of a patient or user if it failed to function as intended. Software meeting that definition is regulated as a medical device.
This is a corporate licensing milestone, not a product approval. The license establishes Craif as a company legally permitted to market highly controlled medical devices in Japan. It does not approve any individual Craif product for sale, and no Craif product has been cleared as a medical device on the basis of it. Each device must still win its own marketing approval.
The company, not the product, holds the license. It is the permission to act as the legally accountable marketer of a device: the entity responsible for quality systems, labeling, distribution and post-market safety. In practical terms, it is the corporate foundation a company has to have in place before an approved device can reach patients.
About Craif
Craif is a bio-AI company founded in 2018 that develops non-invasive tests for the early detection of cancer. Its platform combines proprietary biomarker detection from urine and other bodily fluids with AI to assess disease risk. Building on one of the world's largest urine datasets, Craif aims to create a urine analysis platform that detects a wide range of diseases early, with cancer as the first step. The company is based in Tokyo and operates a wholly owned laboratory in San Diego, opened in 2026. Learn more at craif.com.
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