Regular meeting between the MHLW and the medical device industry
A regular meeting with the Ministry of Health, Labor and Welfare was held on July12, 2023. This meeting is about insurance systems related to medical devices.
The participants were from the Ministry of Health, Labor and Welfare the directorof the Pharmaceutical Industry Promotion and Medical Information Planning Division,
the director of the Medical Division, and the heads of their respective divisions, andfrom the industry side were EBC, JFMDA, AMDD, and JACRI.
The items to be discussed are as follows:1.

Diagnosis/treatment/home equipment①

Regardinginnovation

evaluation

ofmedicaldevices(medicaltechnology)

2.

3.

4.

②

Insurance to promote safety③

Proposals related to medical fees related to home medical careprogrammed medical devices①

Policy support to promote SaMD development②

Developing insurance coverage issues

Specified health and medical materials①

Measures to ensure stable supply②

Review of innovation evaluation

In vitro diagnostic drugs①

Mechanism for evaluating innovations in testing②

Optimization of insurance application examination (elimination ofwaiting

timefor“Insurance

MedicalMaterials

SpecialistSubcommittee”)③“ Reviewing comprehensive evaluation” and “introducing a supportsystem”④for malignant tumor genetic testing

Others - AMR countermeasures, POCT testing

Each item was explained and discussed in detail, but in this report we would like tofocus on the items that have a major impact on our business.
1. Diagnostics/treatment/home equipment
In the case of medical devices that include technology fees, the qualification of C2(new technology) should be clarified. This further improves predictability.

Regard of the medical devices publicly recruited that based on the results of theneeds review committee, consideration should be given to adding points to theevaluation on the medical devices that include technology fees, pioneering medical
devices, and medical devices for specific purposes.
2. Programmed medical devices
Recently, in addition to the conventional regulatory approval system, guidance forappropriate and rapid approval and development of SaMD, including the concept of
two-stage approval, has been published, and an environment for efficientdevelopment and regulatory approval is being prepared.
Furthermore, in order to speed up market introduction, we will utilize new
evaluation treatments after first-stage approval, create an environment that makes
it easier to utilize real-world data in preparation for second-stage approval, andreform the way doctors work.
We would like to see some institutional support, such as evaluating SaMD that
contributes to medical treatment based on medical fees.
There are two types of SaMD, one for disease diagnosis and one for disease
treatment, and each has a different clinical position, so it is necessary to design asystem according to the characteristics of each SaMD.
In particular, the evaluation axis when evaluating based on technical fees, Selectionof applicable technical fees, Definition of functional categories when evaluated as
specified insurance medical materials (special materials), We would like to requestthat predictability be improved by improving the concept of cost accounting.
We would also like to request an evaluation of SaMD, which contributes to reducing
the burden on medical personnel, leveling out the quality of medical care, andreducing medical costs.
3. Specified health and medical materials
Measures to ensure a stable supply of medical devices include responding tounprofitable products, criteria for selecting of unprofitable products, responding tosoaring prices of raw materials and components, reviewing foreign priceadjustments, and accounting rules for newly listed products are recognized forfurther discussions.
Each item requires very detailed discussion, so we look forward to careful
discussions.
Regarding challenge applications, the process of confirming their further usefulness
is important. Companies also need to consider new investments, and it takes acertain amount of time to start them and plan clinical trials.
Furthermore, in addition to providing new technology, by making effective use ofmedical devices that are already on the market, it is also possible to suppress thepurchase of new medical devices.
To this end, we would like you to consider a system that allows us to request achallenge application for a certain period of time from the time we apply forinsurance.
4. In vitro diagnostic drugs
From the perspective of in vitro diagnostic medicine, discussions centered on theappropriate evaluation of highly useful tests, their early commercialization, andsecuring medical fee points that will be lead to appropriate evaluation.
A. Establishment of an innovation evaluation system for testing① Consideration of evaluation methods for usefulness and innovation in testing②

Introduction of challenge application system

B. Optimization of insurance application examination (elimination of waiting timefor “Insurance Medical Materials Specialist Subcommittee”)
C. “Review of comprehensive evaluation” and “introduction of support system” inmalignant tumor genetic testing
D. Other issues surrounding testing
1. To increase the effectiveness of the “Antimicrobial Resistance Countermeasure
Action Plan”
2. Contributing to enhanced local medical care through POCT testingA.
There are no rules for evaluating innovation such as "groundbreaking,''"improvement,'' "usefulness,'' and "marketability,'' which are applied to medical
devices. These are factors that contribute to product development and early
introduction, and we believe that such a system is also necessary for IVD.

Regarding the additinal score of medical fees related to evaluation, we would like to
see an addition of “marketability'' evaluation for unmet needs.
Regarding challenge applications, the application environment in the IVD industry
is similar to that of medical devices, so we would like to request that a system forchallenge applications be established.
B.
During the period from January to March, the company will have to wait for review
due to revisions to medical fees.
Moreover, the impact could extend into May. We would like you to consider ways tosolve this problem. For example, continuing the review by circulating documents,etc. Or, for example, adopting the E2 minor examination method.
C.
Despite the existence of a wide variety of genetic tests for malignant tumors withdifferent clinical significance and measurement techniques, the current system
makes it difficult to conduct appropriate evaluations based on the value of eachindividual test.
Despite being an essential test for determining treatment plans and diagnosis, anddue to insufficient evaluation of development/manufacturing/distribution costs andthe costs necessary to maintain a supply system for quality-assured products,
there are tests that have poor business viability and profitability and pose a highrisk of stable supply.
In order to appropriately evaluate the various tests included in "malignant tumor
genetic testing," we believe that a system is needed to appropriately evaluate thevalue and significance of each test item and technology.
We also think it is necessary to introduce a system for calculating unprofitable items.
(e.g. companion diagnostic etc.)
D.
Concrete measures are needed in the revision of medical fees to increase theeffectiveness of antimicrobial resistance (AMR) action plans.
In order to deliver POCT tests with guaranteed quality and accuracy to clinics andhome-based areas, we would like to see a different system for POCT tests thancurrent tests.
To this end, we should consider adding additional fees for POCT specimen
management and other rapid specimens outside the hospital.

This is the only forum for the medical device/IVD industry to have direct discussions
with the medical division, and we were able to make sufficient recommendations
regarding the issues we considered. Continued discussions will be important in thefuture.