INSTITUTION PROFILE / BIOSENSORS
Ministry of Health, Labour and Welfare (MHLW) and PMDA
Two bodies that split "the rules" and "the review" for medical and diagnostic devices in Japan
To sell a biosensor product such as a blood glucose meter or a continuous glucose monitor (CGM) in Japan, a company needs permits and registrations under the Pharmaceuticals and Medical Devices Act (PMD Act), plus an approval, certification or notification for each product. The Ministry of Health, Labour and Welfare (the Minister) sets the system and issues approvals. The Pharmaceuticals and Medical Devices Agency (PMDA), an independent administrative agency, carries out the review behind each approval and sorts postmarket incident reports. The point to keep in mind when comparing with other countries' regulators is that PMDA does not itself grant approvals. This profile looks at one question only: how much influence the two bodies have over biosensors. It contains no advice on how to use any product or on any reader's personal health.
What this article covers
- MHLW and PMDA in 30 seconds
- What kind of bodies they are: the four types of influence
- What they do for biosensors
- How far their influence reaches (powers and geography)
- Companies and organisations involved
- Outlook
- Glossary, references and claim-to-source audit
1. MHLW and PMDA in 30 seconds
FULL NAMEMinistry of Health, Labour and Welfare (MHLW)
Pharmaceuticals and Medical Devices Agency (PMDA)PMDA is an independent administrative agency
Pharmaceuticals and Medical Devices Agency (PMDA)PMDA is an independent administrative agency
COUNTRYJapanBoth are in Kasumigaseki, Chiyoda-ku, Tokyo (as stated on their websites)
TYPE OF BODYCentral ministry and independent agencyPMDA is a medium-term-objective agency. MHLW rests on the MHLW Establishment Act; PMDA on its own act
ESTABLISHEDPMDA: 1 April 2004We did not confirm MHLW's date of establishment
STAFFMHLW: 32,939 / PMDA: 1,091MHLW's authorised headcount at the end of FY2026 (whole ministry); PMDA's staff as of 1 July 2026
REVIEW RECORDNew devices: 11.9 monthsTotal review time (80th percentile) for new medical devices approved in FY2025, from PMDA's performance report
ROLE IN BIOSENSORSRules, approval, review, reimbursementRunning the PMD Act, PMDA's review, postmarket safety and the reimbursement listing procedure
REACHEvery company marketing in JapanForeign firms need an in-country licence or designated holder. It does not reach other countries' rules
The one thing to grasp first
In Japan the Ministry holds the system and the final decision, and PMDA does the review. The PMD Act says the Minister may have PMDA carry out the review for an approval, in which case the Minister does not review it personally and takes PMDA's review and inspection results into account when approving Sourced. So PMDA is not the body that "grants" approval; it is the body that reviews for approval. Lower-risk devices go through notification, and devices with a certification standard are certified by a private Registered Certification Body, so neither passes through PMDA's review. Saying a device is "approved in Japan" therefore does not tell you which route it took.
2. What kind of bodies they are: the four types of influence
The "institutions" that appear in articles on biosensors (medical devices and in vitro diagnostics) do not make products the way companies do. They can be sorted into four types by the route through which they influence the industry. MHLW and PMDA are both "policy and regulation" bodies.
3. What they do for biosensors
In Japan a biosensor product is treated either as a medical device (such as a CGM sensor) or as an in vitro diagnostic (IVD) reagent (a test reagent or kit that measures blood glucose, for example), and both are regulated in the same chapter of the PMD Act Sourced. The division of work between the two bodies is as follows.
| Item | MHLW | PMDA |
|---|---|---|
| System and law | Administers the PMD Act and regulates from manufacture and sale through postmarket safety (MHLW's description). The Minister defines devices, designates the Specially Controlled, Controlled and General classes, and designates devices subject to certification standards | Does not set the system. Runs an information site on device standards and certification standards |
| Licences and registration | The Minister grants marketing authorisation licences (four kinds: Specially Controlled, Controlled, General and IVD) and registers manufacturing sites (registration is optional for overseas sites) | Carries out QMS (quality management) conformity inspections and similar investigations |
| Approval | The Minister approves, product by product, taking PMDA's review and inspection results into account | Reviews and inspects for approval and notifies the Minister of the results |
| Certification and notification | Sets certification standards and registers the Registered Certification Bodies (10 bodies). Notifications are addressed to the Minister | Inspects the certification bodies. Accepts Class I notifications |
| Consultation | Pre-consultation on reimbursement listing; a help desk for software as a medical device | A free general consultation on classification and required evaluation items, and paid face-to-face advice |
| Postmarket | Orders revisions to precautions for use | Receives, sorts and evaluates incident and adverse-event reports. In FY2025 it received about 330,000 medical device incident and infection reports |
| Reimbursement listing | Handles the procedure and price calculation needed before a new device or IVD can be used in insured care | Does not run the listing procedure (a summary of a PMDA simple consultation is used as a supporting document in certain categories) |
Basis: PMD Act, Articles 23-2 to 23-2-24, and the official pages and briefing materials of PMDA and MHLW (references 1 to 11). The table is our own summary.
Classes and procedures: what counts as approval, certification or notification
| Procedure | Medical devices | In vitro diagnostics | Who reviews or decides |
|---|---|---|---|
| Notification | General Medical Devices (Class I). Self-declaration | Class I (those meeting the standard). Self-declaration | No review. PMDA accepts the notification |
| Third-party certification | Controlled devices with a certification standard (Class II) | Class II (those meeting the standard), and over-the-counter (OTC) test kits | A Registered Certification Body (private, registered by the Minister) |
| Ministerial approval | Specially Controlled devices (Class III and IV), and Controlled devices with no certification standard | Class III, products that do not meet the standard, and new items | PMDA reviews and the Minister approves |
The device classes and procedures follow the diagram in PMDA's briefing material; the IVD classes follow the diagram in the briefing material of PMDA's IVD office. IVD classes (I to III) are a separate scheme from device classes (I to IV).
PMDA's published package insert describes a CGM sensor as a "Specially Controlled Medical Device" with the generic name "glucose monitor system" (JMDN code 44611003) (Dexcom G7 CGM System, medical device approval number 30500BZI00035000) Sourced. PMDA's briefing material, by contrast, gives self-blood-glucose test reagents ("used by patients themselves under a physician's guidance") and OTC test kits such as urine glucose as examples of IVDs Sourced.
Review times, and scale
| Category | PMDA's target (total review time) | FY2025 result | Category |
|---|---|---|---|
| New medical devices (regular) | 14 months at the 80th percentile | 11.9 months | Sourced |
| Improved devices (with clinical data) | 10 months at the 60th percentile | 8.9 months | Sourced |
| Improved devices (no clinical data) | 6 months at the 60th percentile | 5.8 months | Sourced |
| Follow-on devices | We did not confirm the target from the report | 3.7 months (60th percentile) | Sourced |
| IVDs (expert-consultation items) | 12 months at the 80th percentile | 11.7 months | Sourced |
| IVDs (regular items) | 7 months at the 80th percentile | 6.6 months | Sourced |
Source: PMDA's performance report for FY2025 (April 2025 to March 2026). Total review time runs from application to approval, with the report setting out how applicant-side preparation time is treated. A separate PMDA briefing gives guideline figures such as 12 months for new devices (9 months for priority items) and states that these are "a guide, not a guarantee of approval".
A materials engineer's view: where a materials supplier comes in
Approvals and certifications are issued per product (item), not for a material itself. The Act defines the sites that must be registered as those carrying out "design, assembly, sterilisation or other processes specified by ministerial ordinance". Whether a factory that supplies electrode or membrane materials falls under that is set by the ordinance, so this profile does not judge it Sourced. What can be said for certain is that, for devices specified by Cabinet order, the company selling the device is inspected on its manufacturing and quality control (a QMS inspection) at intervals of no less than three years after approval, and that the quality system requirements were aligned with ISO 13485 by the 2021 ordinance revision. Whether a change of material counts as a change to the approved particulars is a question for the device maker.
International touchpoints
| Topic | What the primary sources say | Category |
|---|---|---|
| QMS and ISO 13485 | The QMS ordinance for devices and IVDs was revised on 26 March 2021 to align with ISO 13485:2016. The transition period ran to 25 March 2024 | Sourced |
| MDSAP | MHLW and PMDA have taken part in the Medical Device Single Audit Program (MDSAP) since June 2015, and PMDA has accepted MDSAP audit reports since 2016 (PMDA's description) | Sourced |
| Overseas offices | PMDA's FY2025 performance report says it put two overseas offices to work: the Asia Office (Thailand) and the Washington, D.C. Office | Sourced |
4. How far their influence reaches (powers and geography)
| Aspect | What MHLW and PMDA have | What they do not have |
|---|---|---|
| Powers | Marketing authorisation licences, registration of manufacturing sites, product-by-product approval (the Minister), designating certification standards and registering certification bodies (the Minister), review and inspection for approval (PMDA), sorting postmarket incident information (PMDA), and the reimbursement listing procedure and price calculation (MHLW) | The power to write international standards (administrative certification and approval standards are set by the government, but international standards are written by bodies such as ISO and IEC). Deciding how a device is used in clinical practice. PMDA has no power to grant approval itself (it reviews and reports the result to the Minister) |
| Geography | Medical devices and IVDs marketed in Japan. Foreign makers take part by designating an in-country marketing authorisation holder, or through a domestic company that markets the product | Whether a product may be sold elsewhere. Both take part in international frameworks such as MDSAP, but each country's approval is separate |
| Scale | MHLW's authorised headcount at the end of FY2026 is 32,939 (4,520 in its internal bureaus). PMDA has 1,091 staff (1 July 2026). There are 10 Registered Certification Bodies | We could not confirm, in official documents, a headcount for the staff who review medical devices alone |
| Dialogue with industry | MHLW drew up five-year "Joint Plans 2024" for medical devices and for IVDs after consultation with industry | The plans record the outcome of consultation; they are separate from the final regulatory decisions |
Note: MHLW's headcount is the ministry-wide authorised figure in the summary of the FY2026 organisation and staffing decisions.
5. Companies and organisations involved
Seen from the two bodies, a company is the licensed party that submits a product. The figure below shows the three routes of approval, certification and notification, and the procedures that follow.
| Organisation | Relationship with the two bodies (what primary sources confirm) | Category |
|---|---|---|
| Dexcom | In the package insert PMDA publishes, the foreign special-approval holder of the Dexcom G7 CGM System is Dexcom, Inc. (United States) and the designated marketing authorisation holder is DexCom Japan G.K. | Sourced |
| Abbott | In the FreeStyle Libre (flash glucose monitoring system) package insert, the marketing authorisation holder is Abbott Japan G.K. and the overseas manufacturing site is Abbott Diabetes Care Inc. Approval number 22800BZX00212000. This shows two ways in which a foreign maker can take part | Sourced |
| Registered Certification Bodies (10) | Private third-party bodies registered by the Minister. They must report to the Minister when they grant a certification. PMDA inspects the certification bodies | Sourced |
| Industry | MHLW drew up the "Joint Plan 2024 for Optimising Medical Device Regulation and Review" and the matching plan for IVDs, after consulting industry, on 29 March 2024. Progress is reported to the regular exchange meeting on approval review and safety measures for devices and IVDs | Sourced |
| The FDA and other overseas regulators | PMDA has a Washington, D.C. office and takes part in MDSAP. The FDA's system is covered in a separate profile | Sourced |
6. Outlook
| What the evidence suggests | Primary information it rests on | Category |
|---|---|---|
| A five-year joint plan to optimise device and IVD regulation and review has been running since FY2024. FY2026 is its third year, when the targets are due for review | MHLW press release (29 March 2024) and the IVD plan document: the plan runs five years from FY2024 with a review of targets in year three. We could not confirm what the review will contain | Not yet confirmed |
| The IVD plan includes an item to consider how to regulate products that do not fit the current IVD rules, such as some laboratory developed test (LDT) reagents | The IVD joint plan 2024, under its item on balancing quality and streamlining in application and review. No conclusion has been reached | Not yet confirmed |
| Postmarket reporting for IVDs is planned to change from "adverse-reaction reports" to "defect reports" in May 2028 | PMDA's FY2025 performance report records discussions with industry bodies on the notion of a defect ahead of a system change planned for the 10th year of Reiwa (May 2028). The date is a plan | Not yet confirmed |
| The quality-system requirements for medical devices have completed the move to alignment with ISO 13485:2016 | The QMS ordinance revision (26 March 2021) and the end of the transition period (25 March 2024) | Sourced |
| Reimbursement-listing applications have been filed mainly through e-Gov online services since 1 June 2026 | MHLW's page on reimbursement listing for devices and IVDs | Sourced |
| Rule changes for IVDs look set to continue through 2026 to 2028 | The three items above (the plan review, the LDT-reagent question and the change in reporting). No conclusions on individual points have been published | Inference |
| The summary of Act No. 37 of 2025 (promulgated 21 May 2025) shows no change aimed specifically at medical devices | MHLW's summary covers drug quality assurance, stable supply of prescription drugs, the drug-discovery environment and pharmacies | Not yet confirmed |
7. Glossary
- PMD Act
- The Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (Act No. 145 of 1960), also called the Pharmaceuticals and Medical Devices Act.
- PMDA
- The Pharmaceuticals and Medical Devices Agency. It runs approval review, safety measures and relief for adverse health effects as one body.
- Approval, certification, notification
- The Minister approves, a Registered Certification Body certifies, and the company files a notification. The higher the risk, the more likely approval is required.
- Registered Certification Body
- A private body registered by the Minister that certifies devices and IVDs for which a certification standard exists.
- Specially Controlled Medical Device
- A device the Minister designates because a malfunction or side effect could seriously affect life or health (Japanese: koudo kanri iryo kiki).
- In vitro diagnostic (IVD)
- A reagent or kit that examines specimens such as blood for diagnosis. In Japan it is treated as a kind of pharmaceutical and regulated in the same chapter as devices.
- Foreign special approval
- A system under which a foreign maker obtains approval for a product through a designated in-country marketing authorisation holder.
- QMS inspection
- An inspection of how well a manufacturing site's quality management is carried out. PMDA and others conduct it.
- MDSAP
- The Medical Device Single Audit Program, which lets one audit serve the regulations of several countries.
8. References
- e-Gov Laws Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (Act No. 145 of 1960; in Japanese): Article 2 (definitions), Articles 23-2 to 23-2-24 (marketing authorisation licences, manufacturing registration, approval, review by PMDA, notification, certification) and Article 68-10. https://laws.e-gov.go.jp/law/335AC0000000145
- e-Gov Laws Act for Establishment of the Ministry of Health, Labour and Welfare (Act No. 97 of 1999; in Japanese): Article 3 (mission) and Article 4 (duties). https://laws.e-gov.go.jp/law/411AC0000000097
- MHLW Pharmaceuticals and Medical Devices (in Japanese): consistent regulation under the PMD Act, development-support schemes and a link to the registered certification body scheme. https://www.mhlw.go.jp/seisakunitsuite/bunya/kenkou_iryou/iyakuhin/index.html
- MHLW About the Registered Certification Body system (in Japanese): how third-party certification works, the 10 registered bodies and the reporting duty. https://www.mhlw.go.jp/stf/seisakunitsuite/bunya/kenkou_iryou/iyakuhin/touroku/index.html
- MHLW Reimbursement listing for medical devices and IVDs (in Japanese): the listing procedure and e-Gov online filing of listing applications. https://www.mhlw.go.jp/stf/seisakunitsuite/bunya/0000176120.html
- MHLW Summary of the FY2026 organisation and staffing of MHLW (in Japanese): authorised headcount of 32,939 at the end of FY2026, of which 4,520 in internal bureaus. https://www.mhlw.go.jp/content/10108000/001620628.pdf
- MHLW Press release on the Joint Plans 2024 for Optimising Medical Device Regulation and Review, and for IVDs (in Japanese, 29 March 2024). https://www.mhlw.go.jp/stf/newpage_39336.html
- MHLW Joint Plan 2024 for Optimising IVD Regulation and Review (in Japanese): plan period, review of targets in year three, the item on regulating LDT reagents and standard processing times. https://www.mhlw.go.jp/content/11124500/001238428.pdf
- MHLW Summary of Act No. 37 of 2025 amending the PMD Act and other laws (in Japanese). https://www.mhlw.go.jp/content/11120000/001492021.pdf
- PMDA About PMDA (in Japanese): establishment on 1 April 2004, medium-term-objective agency status, its three functions and address. https://www.pmda.go.jp/about-pmda/outline/0001.html
- PMDA Organisation overview (in Japanese): 6 officers and 1,091 staff as of 1 July 2026. https://www.pmda.go.jp/about-pmda/info-about-pmda/0010.html
- PMDA Briefing material of the PMDA Medical Device Unit on device classification and review departments (in Japanese): classes and the notification, certification and approval routes, and the roles of MHLW and PMDA. https://www.pmda.go.jp/files/000273968.pdf
- PMDA Briefing material of the PMDA Medical Device Unit on application categories and generic names (in Japanese): guideline review times and the difference between approval and certification. https://www.pmda.go.jp/files/000273971.pdf
- PMDA Briefing material of PMDA's IVD office on consultation and applications for IVDs (in Japanese): classes and who reviews, and the standard review process. https://www.pmda.go.jp/files/000273975.pdf
- PMDA Performance report for FY2025 (in Japanese): review-time results, incident-report counts, overseas offices and the planned change in IVD reporting. https://www.pmda.go.jp/files/000282524.pdf
- PMDA (published package insert) Package insert for the Dexcom G7 CGM System (in Japanese): Specially Controlled Medical Device, generic name "glucose monitor system", approval number 30500BZI00035000, designated marketing authorisation holder and foreign special-approval holder. https://www.pmda.go.jp/PmdaSearch/kikiDetail/ResultDataSetPDF/471981_30500BZI00035000_B_01_03
- PMDA (published package insert) Package insert for FreeStyle Libre (in Japanese): approval number 22800BZX00212000, marketing authorisation holder and overseas manufacturing site. https://www.pmda.go.jp/PmdaSearch/kikiDetail/ResultDataSetPDF/100159_22800BZX00212000_B_01_08
- PMDA Revision of Japanese Medical Device QMS requirements: alignment with ISO 13485:2016 and a transition period to 25 March 2024. https://www.pmda.go.jp/english/review-services/regulatory-info/0004.html
- PMDA MDSAP: Japan's participation since June 2015 and acceptance of audit reports since 2016. https://www.pmda.go.jp/english/review-services/gmp-qms-gctp/0004.html
- MHLW Home page (in Japanese): address in Kasumigaseki 1-2-2, Chiyoda-ku, Tokyo. https://www.mhlw.go.jp/
9. Claim-to-source audit
| Claim in the article | Category | Source |
|---|---|---|
| The PMD Act's definitions (device classes), the four kinds of marketing licence, manufacturing registration and optional registration of overseas makers | Sourced | Reference 1 https://laws.e-gov.go.jp/law/335AC0000000145 |
| Approval by the Minister, review and inspection by PMDA taken into account by the Minister, PMDA accepting notifications, certification by Registered Certification Bodies, and foreign special approval with a designated holder | Sourced | Reference 1 https://laws.e-gov.go.jp/law/335AC0000000145 |
| Inspections at intervals of no less than three years for devices specified by Cabinet order, and the processes covered by site registration | Sourced | Reference 1 https://laws.e-gov.go.jp/law/335AC0000000145 |
| MHLW's mission and duties (including devices) and its legal basis | Sourced | Reference 2 https://laws.e-gov.go.jp/law/411AC0000000097 |
| Consistent regulation under the PMD Act from manufacture to postmarket | Sourced | Reference 3 https://www.mhlw.go.jp/seisakunitsuite/bunya/kenkou_iryou/iyakuhin/index.html |
| Ten Registered Certification Bodies, the certification requirement and the reporting duty | Sourced | Reference 4 https://www.mhlw.go.jp/stf/seisakunitsuite/bunya/kenkou_iryou/iyakuhin/touroku/index.html |
| The reimbursement listing procedure, price calculation and e-Gov filing (mainly from 1 June 2026) | Sourced | Reference 5 https://www.mhlw.go.jp/stf/seisakunitsuite/bunya/0000176120.html Reference 12 https://www.pmda.go.jp/files/000273968.pdf |
| MHLW's authorised headcount of 32,939 (4,520 in internal bureaus) and its address | Sourced | Reference 6 https://www.mhlw.go.jp/content/10108000/001620628.pdf Reference 20 https://www.mhlw.go.jp/ |
| The Joint Plans 2024 (29 March 2024), the five-year period, the year-three review, the LDT-reagent item and standard processing times | Sourced | Reference 7 https://www.mhlw.go.jp/stf/newpage_39336.html Reference 8 https://www.mhlw.go.jp/content/11124500/001238428.pdf |
| PMDA's establishment (1 April 2004), medium-term-objective status, its three functions and address | Sourced | Reference 10 https://www.pmda.go.jp/about-pmda/outline/0001.html |
| PMDA's 1,091 staff and 6 officers (1 July 2026) | Sourced | Reference 11 https://www.pmda.go.jp/about-pmda/info-about-pmda/0010.html |
| Device classes and the notification, certification and approval routes; roles of MHLW and PMDA (reimbursement and pricing sit with MHLW) | Sourced | Reference 12 https://www.pmda.go.jp/files/000273968.pdf |
| The difference between approval and certification, and guideline review times (new devices 12 months and so on) | Sourced | Reference 13 https://www.pmda.go.jp/files/000273971.pdf |
| IVD classes and who reviews, and the placement of OTC kits and self-blood-glucose reagents | Sourced | Reference 14 https://www.pmda.go.jp/files/000273975.pdf |
| FY2025 review-time results (new devices 11.9 months and so on) and targets, IVD results, about 330,000 incident reports and overseas offices | Sourced | Reference 15 https://www.pmda.go.jp/files/000282524.pdf |
| The planned change in IVD postmarket reporting (May 2028) | Not yet confirmed | Reference 15 https://www.pmda.go.jp/files/000282524.pdf |
| Dexcom G7: Specially Controlled Medical Device, the glucose monitor system, approval number, designated holder and foreign special-approval holder | Sourced | Reference 16 https://www.pmda.go.jp/PmdaSearch/kikiDetail/ResultDataSetPDF/471981_30500BZI00035000_B_01_03 |
| FreeStyle Libre: approval number, marketing authorisation holder and overseas manufacturing site | Sourced | Reference 17 https://www.pmda.go.jp/PmdaSearch/kikiDetail/ResultDataSetPDF/100159_22800BZX00212000_B_01_08 |
| The QMS ordinance revision (26 March 2021), alignment with ISO 13485:2016 and the end of the transition (25 March 2024) | Sourced | Reference 18 https://www.pmda.go.jp/english/review-services/regulatory-info/0004.html |
| Participation in MDSAP (from June 2015) and acceptance of audit reports (from 2016) | Sourced | Reference 19 https://www.pmda.go.jp/english/review-services/gmp-qms-gctp/0004.html |
| The summary of Act No. 37 of 2025 (focused on drug quality, supply, drug discovery and pharmacies) | Sourced | Reference 9 https://www.mhlw.go.jp/content/11120000/001492021.pdf |
| The four types of institution, and the mapping to routes in Fig. 2 | Our calculation | Our own classification |
| What the year-three review of the plans will contain, and the conclusion on LDT reagents | Not yet confirmed | Not stated in the references; this article does not estimate it |
| A headcount for staff who review medical devices alone | Not yet confirmed | Not stated in the references; this article does not estimate it |
| The inference in section 6 | Inference | This article's reading of references 7, 8 and 15 |
Last updated 3 October 2026 / Troy Technical
All figures come from the text of the PMD Act, the official websites, briefing materials and performance report of MHLW and PMDA, and package inserts published by PMDA. Items marked "Inference" are this article's reading of the primary information. Nothing here is advice on how to use any product or on any reader's personal health.