Regulatory topic
Japan PMDA: new medical device approvals, searchable in English
PMDA reviews new and high-risk medical devices for Japan's Ministry of Health, Labour and Welfare. MedTech Signal holds PMDA's English list of approved new devices and links the US clearances it cites to our FDA records.
Three routes to market in Japan
Class I devices are notified; many Class II and some Class III devices with a certification standard are certified by registered third-party bodies; new and higher-risk devices need MHLW approval after PMDA review. PMDA's English list covers new devices approved through the last route, plus major partial changes.
What it does not show
The list does not include certified or notified devices, or most generic approvals, so it is not a register of every device sold in Japan. Not finding a device never means it is unapproved. We show 'No approvals found in the PMDA list', nothing stronger.
What MedTech Signal shows
Every approval since April 2004 with date, brand, applicant, review area, classification, summary and review time. Where PMDA cites a US 510(k), PMA or De Novo number we link it to our FDA record, so you can compare timing between the two markets. Each entry links to its page in PMDA's list.
Who uses this
Market-access teams planning a Japanese submission and benchmarking review times, competitive-intelligence teams tracking which innovations reached Japan, and investors comparing a company's US and Japanese approvals.
Held: PMDA's English list of approved new medical devices, April 2004 onward (about 1,500 entries), checked weekly. Not held: certified or notified devices, Japanese-only records, review report text. Source: pmda.go.jp.