Japan · Devices · IVDs · 外国製造業者登録

New foreign medical device manufacturers registered in Japan

Name: Foreign medical device, IVD and regenerative product manufacturer registrations in Japan: weekly counts by country
Creator: Japan Pharma Regulatory Brief

Weekly counts of foreign manufacturing sites newly registered with MHLW to make medical devices, IVDs and regenerative products for Japan, by country. What registration is ↓

Last updated: 2026-09-27 · PMDA foreign manufacturer list as of 2026-09-16 · source: PMDA (PDL1.0), edited and aggregated

New registrations per week, by product type

Registrations we judge to be first-time, by registration date, last 26 weeks. Renewals are left out of the bars (they are in the table view and the CSV). Hover a week for the numbers. Download: weekly counts by country and type (CSV, aggregated).

Medical devices
IVDs
Regenerative products

Show as a table

Week starting	Medical devices new	IVDs new	Regenerative products new	Total new	Renewals
2026-09-14*	0	0	0	0	11
2026-09-07	20	0	1	21	14
2026-08-31	9	0	0	9	8
2026-08-24	20	0	2	22	22
2026-08-17	13	0	0	13	14
2026-08-10	11	0	0	11	28
2026-08-03	9	0	0	9	13
2026-07-27	17	0	0	17	11
2026-07-20	10	0	0	10	11
2026-07-13	23	0	1	24	13
2026-07-06	27	0	2	29	21
2026-06-29	0	0	0	0	16
2026-06-22	16	0	2	18	13
2026-06-15	16	1	0	17	18
2026-06-08	31	0	1	32	18
2026-06-01	12	0	0	12	17
2026-05-25	19	1	1	21	14
2026-05-18	0	0	0	0	27
2026-05-11	33	0	0	33	11
2026-05-04	11	0	0	11	9
2026-04-27	11	0	0	11	6
2026-04-20	21	0	0	21	21
2026-04-13	23	0	0	23	26
2026-04-06	5	1	0	6	8
2026-03-30	12	0	0	12	13
2026-03-23	11	0	0	11	7

How “new” is estimated: PMDA shows only the latest registration or renewal date. Registration numbers are issued in sequence for each country, so when a later number already carries an earlier date, the date on an earlier number must be a renewal. Checks on the 2026 list: every number we mark as new has neighbouring numbers issued within a few months, while renewals line up with the 5-year anniversaries of their neighbours. It is an estimate, not PMDA's label. * The latest week is partial (list as of 2026-09-16); PMDA updates the list about monthly, so the last few weeks fill in later.

Need a Designated Marketing Authorization Holder (DMAH) in Japan? A foreign manufacturer registration lets your site make devices for Japan, but a Japanese marketing authorization holder must still put them on the market. Compare DMAH / in-country service providers →

Top 20 countries

Active registrations (excluding abolished and expired ones) by the country PMDA lists for the site, with the number of new registrations in the 12 months to 2026-09-16.

Medical device (7,779 active)

#	Country	Active	Share	New, 12 mo
1	China	1,801	23%	355
2	United States	1,780	23%	118
3	Germany	723	9%	22
4	South Korea	582	7%	71
5	Taiwan	281	4%	16
6	Italy	211	3%	9
7	France	206	3%	13
8	United Kingdom	176	2%	14
9	Switzerland	175	2%	7
10	Israel	137	2%	12
11	Mexico	134	2%	9
12	Malaysia	127	2%	3
13	Pakistan	100	1%	8
14	Sweden	88	1%	4
15	Ireland	85	1%	8
16	Canada	78	1%	5
17	India	67	1%	7
18	Viet Nam	67	1%	10
19	Thailand	66	1%	4
20	Netherlands	64	1%	2

In vitro diagnostic (IVD) (348 active)

#	Country	Active	Share	New, 12 mo
1	United States	104	30%	0
2	China	70	20%	0
3	United Kingdom	34	10%	0
4	South Korea	23	7%	0
5	Germany	21	6%	0
6	France	17	5%	0
7	Canada	10	3%	0
8	Finland	8	2%	0
9	Taiwan	7	2%	0
10	Spain	6	2%	0
11	Austria	5	1%	1
12	Sweden	5	1%	0
13	Hong Kong	5	1%	0
14	Ireland	4	1%	0
15	Belgium	4	1%	0
16	Italy	4	1%	0
17	Switzerland	4	1%	0
18	India	3	1%	0
19	Puerto Rico (US)	2	1%	0
20	Israel	2	1%	0

Regenerative medical product (64 active)

#	Country	Active	Share	New, 12 mo
1	United States	37	58%	6
2	United Kingdom	8	12%	0
3	Switzerland	3	5%	1
4	Finland	3	5%	0
5	South Korea	2	3%	0
6	Austria	2	3%	0
7	Germany	2	3%	0
8	Ireland	1	2%	1
9	Netherlands	1	2%	1
10	Australia	1	2%	1
11	Italy	1	2%	1
12	Spain	1	2%	0
13	Taiwan	1	2%	0
14	Belgium	1	2%	0

Latest 20 new registrations

The 20 most recent registrations we judge to be first-time (as of 2026-09-16). The free list shows the date, country, type and company only.

Registered	Country	Type	Company
2026-09-11	Ireland	Regenerative products	ALMAC PHARMA SERVICES LIMITED
2026-09-11	United States	Medical devices	The Belport Company, Inc., DBA Gingi-Pak
2026-09-11	Latvia	Medical devices	SIA AGM Orthopaedics
2026-09-11	Italy	Medical devices	TECHNIX SPA
2026-09-11	Italy	Medical devices	A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI S. R. L..
2026-09-11	Thailand	Medical devices	Team Precision Public Company Limited
2026-09-11	China	Medical devices	Shenzhen Lodden Medical Technology Co., Ltd.
2026-09-11	China	Medical devices	Yantai Lumian Knitting Co., Ltd.
2026-09-11	China	Medical devices	Amsino Healthcare (Shanghai) Co., Ltd.
2026-09-07	Germany	Medical devices	northh medical GmbH
2026-09-07	Ireland	Medical devices	Vivasure Medical Ltd
2026-09-07	Ireland	Medical devices	Vivasure Medical Ltd
2026-09-07	Israel	Medical devices	Nistec Zafon Ltd
2026-09-07	Myanmar	Medical devices	Myanmar Silver Spring Enterprises Limited
2026-09-07	China	Medical devices	WELLMED DENTAL MEDICAL SUPPLY CO.,LTD
2026-09-07	China	Medical devices	Taizhou Hongwei Glasses Co., Ltd
2026-09-07	China	Medical devices	Qingdao Kiharu Import And Export Co., Ltd
2026-09-07	China	Medical devices	諸城千針服飾有限公司
2026-09-07	China	Medical devices	常州三佳服飾有限公司
2026-09-07	China	Medical devices	巨野県澤士服装有限公司

What the full list adds (subscribers)

This page is the free summary. The planned subscriber edition adds:

Every new registration, every week — registration number, site name and address, parent company, registration category, expiry date.
Competitor and supplier watch — an email when a company or country you follow gets a new Japan registration.
Full CSV of all active foreign device, IVD and regenerative product manufacturers, with renewal due dates.

Join the free weekly email for the headline count now and the launch note for the full list. Sign up free ↓

What is foreign manufacturer registration in Japan?

A company outside Japan that manufactures medical devices, in vitro diagnostics (IVDs) or regenerative medical products for the Japanese market must have each relevant site registered with the Minister of Health, Labour and Welfare (MHLW) — 外国製造業者登録 — under the Act on Pharmaceuticals and Medical Devices (PMD Act, Article 23-2-4 for devices and IVDs; regenerative products have their own accreditation). PMDA handles the paperwork and publishes the list for MHLW.

Who needs it: sites responsible for design, main assembly, sterilization or final-product storage for the Japanese market (the scope depends on the device class). Since the 2014 PMD Act reform most device sites are “registered” (登録) rather than individually accredited.
Validity: 5 years, then renewal. On PMDA's list a renewal keeps the number but replaces the date, so the date column alone does not tell a new site from a renewed one.
What it is not: it is not a product approval or certification. Products still need approval, certification or notification, held by a Japanese marketing authorization holder — for foreign makers usually a Designated Marketing Authorization Holder (DMAH, 選任製造販売業者).

PMDA's English guidance: Accreditation/registration of foreign manufacturers.

Methodology

We read PMDA's Excel list of foreign manufacturers (medical devices, IVDs, regenerative products), keep one row per registration number, and drop abolished numbers and numbers past their expiry date with no renewal application.
Country is the country PMDA lists for the site. Company is the parent company in PMDA's English-font column.
233 registrations carry a date after the list date: renewals processed before the old term ended. They count as renewals.
From the second edition of the list onward we also compare editions: numbers not on the previous edition are new, and numbers whose date moved forward are renewals.
The CSV holds weekly counts by country, type and new/renewal for the 26 weeks shown — no company-level data.

Sources & attribution

Source: Pharmaceuticals and Medical Devices Agency (PMDA) website (https://www.pmda.go.jp/), PDL1.0: “外国製造業者認定・登録番号の公表” (registered and accredited foreign manufacturers, published by PMDA for MHLW, https://www.pmda.go.jp/review-services/drug-reviews/foreign-mfr/0003.html, list as of 2026-09-16). Created by editing, translating and aggregating this material (country assignment, the new-vs-renewal estimate, weekly counts and charts are ours). Not an official PMDA or MHLW list.

出典：独立行政法人医薬品医療機器総合機構（PMDA）ウェブサイト「外国製造業者認定・登録番号の公表」（https://www.pmda.go.jp/review-services/drug-reviews/foreign-mfr/0003.html）を加工して Japan Pharma Regulatory Brief が作成

Used under the Public Data License 1.0 (PDL1.0) (compatible with CC BY 4.0); see PMDA's site policy. This page is not made by, affiliated with or endorsed by PMDA or MHLW. The Japanese original prevails.

Last built: 2026-09-27.