Medical Devices In Japan Research Articles

An Introduction to Regulatory Aspects Related to Medical Devices in Japan and Canada

Background: A medical device is a gadget that is used to identify, prevent, or treat illness or other medical conditions, but it does not work chemically on or within the body. It includes instruments, apparatus, implants, in vitro reagents, and similar or related items. The approval process for medical equipment in regulated markets (such as those in Canada and Japan) is one of the major concerns for their proper induction. The categorization of medical equipment and the procedure for their approval in these nations and their companions need to be clearly addressed in order to facilitate a better understanding of the regulations. Aim: The regulatory considerations regarding the Japanese regulatory body for medical devices have been well discussed. Further, other aspects, such as the organization of the study of medical devices and the clearance process with the Ministry of Health, Labour, and Welfare's role in Japan's medical device industry, have been elaborated. Medical device licensing and application procedures in this regard with the leading Japanese medical equipment manufacturers have been revealed. Results/Discussion: In Canada, medical equipment post-market surveillance on risk-based categorization has been revealed. The organisational structure of the medical equipment governing body and the Canadian approval process for medical instruments included by Health Canada with the top 10 medical technology setups in Canada have been elaborated in detail. Conclusion: In this review, regulatory aspects in Japan and Canada for understanding the direction and evolution of the medical device industry have been discussed. This analysis aims to provide a more comprehensive understanding of the regulatory framework governing the marketing authorisation of diagnostic and therapeutic medications in Japan and Canada to a global audience.

Regulatory-approved deep learning/machine learning-based medical devices in Japan as of 2020: A systematic review.

Machine learning (ML) and deep learning (DL) are changing the world and reshaping the medical field. Thus, we conducted a systematic review to determine the status of regulatory-approved ML/DL-based medical devices in Japan, a leading stakeholder in international regulatory harmonization. Information about the medical devices were obtained from the Japan Association for the Advancement of Medical Equipment search service. The usage of ML/DL methodology in the medical devices was confirmed using public announcements or by contacting the marketing authorization holders via e-mail when the public announcements were insufficient for confirmation. Among the 114,150 medical devices found, 11 were regulatory-approved ML/DL-based Software as a Medical Device, with 6 products (54.5%) related to radiology and 5 products (45.5%) related to gastroenterology. The domestic ML/DL-based Software as a Medical Device were mostly related to health check-ups, which are common in Japan. Our review can help understanding the global overview that can foster international competitiveness and further tailored advancements.

Revised GMP Ministerial Ordinance and current topics on regulations of pharmaceuticals and medical devices in Japan

Revised GMP Ministerial Ordinance and current topics on regulations of pharmaceuticals and medical devices in Japan

Japan-USA Orbital Atherectomy for Calcific Coronary Lesions: COAST Study, a Harmonization by Doing Proof-of-Concept: The Japanese and US Regulatory Perspective

Regulatory approval processes for medical devices in Japan and the United States of America (US) often require similar clinical trials to establish safety and effectiveness. The Harmonization by Doing (HBD) program provides a collaborative environment for communication between regulators, academics and industry, facilitating the design and conduct of US/Japanese clinical trials supporting approval in both countries.

Comparison of supportive regulatory measures for pediatric medical device development in Japan and the United States

Further development of medical devices for children is required in Japan, but the development of such devices is delayed compared to that of medical devices for adults. Herein, we investigated policies for advancing the development of pediatric medical devices in Japan and the United States. Considering the achievements of each policy, we proposed a strategy to promote further development of pediatric medical devices in Japan. We investigated policies for supporting the development of pediatric medical devices and approved cases in Japan and the United States by searching contents of websites of regulatory bodies and other related administrations, and scientific papers. We found the main six policies in Japan and nine main policies in the United States for the development of pediatric medical devices. In the United States, various measures have initiated mainly in the 2000s, while in Japan, the main measures have been in place since 2013. Similarities were found in both countries, such as subsidies for application fees and research and development expenses, exemption of requirements for regulatory approval, and priority review and consultation by the regulatory body. Our study revealed that there are similarities in initiatives by both countries. To promote further development of pediatric medical devices in the future, improvements to expediting the review process to approval by the regulatory body, global development, and implementation of alternative measures to ensure the efficacy and safety of the device instead of large-scale clinical trials should be anticipated through cooperation among industry, government, and academia.

Recent Least Burdensome Approach for the Approval of Innovative Medical Devices in Japan -Regulatory Approval Review of an Everolimus-eluting Bioresorbable Scaffold.

Although a domestic trial in Japan revealed that Absorb bioresorbable vascular scaffold (BVS) has no inferiority to everolimus-eluting stent (EES) cohort in the primary endpoint of the target lesion failure at 12 months, the scaffold/stent thrombosis (ST) rates with the BVS at 24 months were higher than those with the EES (Absorb BVS 3.1% vs. EES 1.5%), the ST rate of 3.1% with Absorb BVS is not an acceptable level in Japan. A cause-of-ST analysis revealed that cases in which diagnostic imaging and ensuing post-dilatation had been performed appropriately had lower ST rates than those without such management (within 1 year: 1.37% vs. 7.69%, from 1 to 2 years: 0.00% vs. 8.33%). Therefore, a further evaluation was needed to confirm that the ST rate with the Absorb BVS would be reduced by a proper implementation procedure. Regulatory approval was given conditionally to initiate rigorous post-marketing data collection in order to ensure the proper use of this device in limited facilities. The One-year Use-Result Survey in Japan for the Absorb BVS revealed no instances of ST. This approach to reducing the premarket regulatory burden of clinical trials and enhancing the post-marketing commitments of medical device regulation is useful for expediting patient access to innovative medical devices.

Regulations, Measures and Future Issues of Cybersecurity for Medical Devices in Japan

Regulations, Measures and Future Issues of Cybersecurity for Medical Devices in Japan

Recalls and Premarket Review Systems for High-Risk Medical Devices in Japan.

In Japan, different regulatory tracks prior to marketing have been applied to medical devices dependent on whether they have predefined certification or approval standards in addition to the risk category. A regulatory track for some high-risk medical devices (class III or IV in Japan) using certification standards newly became effective in 2014. This study aimed to explore potential candidate devices for the certification track. We analyzed approval, recall, and classification information databases for medical devices in Japan. High-risk medical devices approved between 2010 and 2014 were examined (N = 3222). The medical devices were categorized into 3 groups based on availability of certification or approval standards. Recall rates were calculated for each group and for each device category within the groups. Recall reasons were classified into two main categories: design problems and other problems. The overall recall rates were 12.1% in the group with certification standards (recalled n = 17, approved n = 141), 4.1% in the group with approval standards (recalled n = 49, approved n = 1187), and 5.6% in the group without either standard (recalled n = 106, approved n = 1894). The design recall rates were 9.2%, 1.4%, and 1.6%, respectively. The recall rate for bio-phenomena-monitoring devices was high (recalled n = 13, approved n = 31; 41.9%), which contributed to the high recall rate of the group with certification standards. The overall recall rates and the recall rates due to design problems varied considerably across and within the 3 groups. As possible good candidates for the transition into the new certification track, high-risk medical devices with low recall rates in frequently approved device categories should be given priority.

Price Effects of Target Ratcheting: A Progress Report on Medical Devices

Regulators, who have asymmetric information concerning the technology of regulated firms, often rely on incentive-based regulation. While such a scheme is well known to be vulnerable to the adverse incentives of regulated firms, empirical research that quantifies the magnitude of distortion caused by incentive regulation is scarce. This paper is a progress report of our recent project on target ratcheting with an application to medical devices in Japan. A casual observation of detailed product-level transaction data and reduced-form analyses indicate the existence of pricing distortion in the wholesale market. The paper also proposes a two-period bilateral bargaining model to match the data. A preliminary analysis finds evidence consistent with the hypothesis that target ratcheting distorts the pricing of regulated firms, but the magnitude of the distortion is estimated to be economically small.

Application of economic evaluation of pharmaceuticals and medical devices in Japan

Application of economic evaluation of pharmaceuticals and medical devices in Japan

Reimbursement pricing for new medical devices in Japan: Is the evaluation of innovation appropriate?

SummaryObjectivesIn Japan, strong reimbursement pricing control measures for existing medical device products have rendered new medical device reimbursement pricing critical for manufacturers. Few studies have been conducted on this aspect; therefore, this paper (1) clarifies whether evaluation of innovation is appropriate or not and (2), if not, investigates its background.MethodsIn this research, 319 C1/C2 government decisions for new medical devices in the 10 years from April 2008 to March 2018 were analyzed. Evaluation of innovation was considered in terms of the reimbursement price, as well as the foreign average price ratio.ResultsConsidering the degree of evaluation of innovation, the average premium rate for the similar function category comparison method was 10.2% during 2008 to 2010 (this means the newly set reimbursement price was 10.2% higher than that of corresponded exiting categories); it declined consistently thereafter, to 3.2% during 2016 to 2018. Moreover, evaluation of innovation by the foreign average price (FAP) ratio was 1.04 in 2008 to 2010, consistently decreasing to 0.88 in 2016 to 2018. The period from product approval to the non‐Special Designated Treatment Material (non‐STM) (a part of technical fee) price listing is much longer than that of the STM (own reimbursement price) listing.ConclusionSeveral reasons were considered for the decline in innovation evaluation: (1) the lowering of the FAP upper limit ratio, (2) the possibility that there was not enough evidence at the time of price listing, (3) and the more rigorous standards to create a new separate functional category. However, some aspects were attributable to reimbursement system reform.

Trial Implementation of Quasi Value-based Pricing for Pharmaceuticals and Medical Devices in Japan: Issues in Dispute

Au Japon, le prix des médicaments remboursables est égal à un prix de base majoré d’une « prime » reflétant le caractère plus ou moins innovant du produit. Bien que des considérations économiques interviennent dans ce calcul, la méthode employée laisse une large place à la subjectivité – raison pour laquelle nous parlons de « Quasi Value-Based Pricing ». Confronté à une explosion des dépenses de santé, le ministère de la Santé, du Travail et des Affaires sociales a chargé un comité ad hoc créé au sein du CMC, l’instance compétente en matière de fixation du prix des médicaments, de définir une nouvelle méthode d’évaluation économique des technologies de santé. Une expérimentation a été lancée en avril 2016 pour sept médicaments et six dispositifs médicaux remboursables. L’objectif était de définir une méthode pour recalculer le prix de ces produits, puis de déployer l’expérimentation à plus grande échelle. Initialement prévu pour mars 2018, ce déploiement a été reporté d’une année faute de consensus, la méthode de calcul proposée ayant suscité de vives critiques des scientifiques et de l’industrie pharmaceutique. La proposition consiste à calculer le ratio différentiel coûts-résultats (RDCR) en lui appliquant un taux d’actualisation pour tenir compte de critères éthiques et sociaux, puis à calculer le prix en fonction de formules algorithmiques différentes selon le niveau du RDCR. Outre le fait que la méthode employée pour moduler le RDCR est scientifiquement discutable et que, pour transparente qu’elle soit, l’utilisation de formules algorithmiques associées à un niveau de RDCR donné comporte un risque d’arbitraire et n’offre aucune souplesse, la réforme telle qu’elle est envisagée n’encourage pas l’innovation. Pour remédier à ces faiblesses, nous proposons une démarche en deux phases : une phase d’évaluation scientifique reposant sur une méthode pharmaco-économique valide et une phase de délibération. Nous insistons sur le fait que la mise au point d’une méthode de calcul, quelle qu’elle soit, exige des compétences extrêmement pointues, qui sont rares au Japon, ce qui plaide en faveur de la création d’une autorité publique d’évaluation des technologies de santé. Nous concluons notre article en invitant les autres pays à tirer des enseignements de l’expérience du Japon et des controverses soulevées par la réforme.

Is the total review time of new medical devices related to the size of the company?: Medical devices development and its related factors in Japan

Japan has one of the largest medical device markets in the world, but most devices used in Japan are pioneered by foreign medical device companies. On the other hand, medical device companies in Japan have significant potential to develop innovative medical devices. Through this research, we aim to elucidate the factors related to the total review time of new medical devices so that innovative medical devices would be developed sooner. Using the lists of approved medical devices disclosed by the Pharmaceuticals and Medical Devices Agency (PMDA), we chose all the new medical devices that were approved in Japan between Fiscal Year (FY) 2009 and 2015. We conducted two main types of analyses based on the total review time after submission and sales of the companies. The total review time tends to decrease with "Year of approval by the PMDA'' in FY 2009 to 2015 (p < 0.001). Moreover, the total review time of small and medium-sized companies is greater than that of large companies (p = 0.004). In conclusion, the total review time of new medical devices in Japan appears to be related to the following two factors: (1) year of approval, and (2) size of the enterprise.https://doi.org/10.21423/jrs-v06n02p024 (DOI assigned 1/24/2019)

The Clinical Innovation Network: a policy for promoting development of drugs and medical devices in Japan

The continuous increase in the costs of developing new drugs and medical devices drives increases in medical expenses. Seventy to ninety percent of these costs are associated with clinical trials. Therefore, the development of cost-effective methods to perform clinical trials remains a challenge. One approach is to use patient registries, collections of data related to patients with a specific diagnosis, condition, or procedure. Patient registries are used in Denmark, Sweden, and the USA for the enrollment of patients into clinical trials, and to evaluate endpoints. In Japan, a national project for registry-oriented clinical research, termed the 'Clinical Innovation Network' (CIN), was initiated in 2016. Here, we provide an overview of the CIN and discuss its impact on drug and device development in Japan.

Present status of reuse of single-use medical devices in Japan and market size of remanufactured single-use devices

Present status of reuse of single-use medical devices in Japan and market size of remanufactured single-use devices

A Web-based searchable system to confirm magnetic resonance compatibility of implantable medical devices in Japan: a preliminary study.

Confirmation of the magnetic resonance (MR) compatibility of implanted medical devices (IMDs) is mandatory before conducting magnetic resonance imaging (MRI) examinations. In Japan, few such confirmation methods are in use, and they are time-consuming. This study aimed to develop a Web-based searchable MR safety information system to confirm IMD compatibility and to evaluate the usefulness of the system. First, MR safety information for intravascular stents and stent grafts sold in Japan was gathered by interviewing 20 manufacturers. These IMDs were categorized based on the descriptions available on medical package inserts as: "MR Safe," "MR Conditional," "MR Unsafe," "Unknown," and "No Medical Package Insert Available". An MR safety information database for implants was created based on previously proposed item lists. Finally, a Web-based searchable system was developed using this database. A questionnaire was given to health-care personnel in Japan to evaluate the usefulness of this system. Seventy-nine datasets were collected using information provided by 12 manufacturers and by investigating the medical packaging of the IMDs. Although the datasets must be updated by collecting data from other manufacturers, this system facilitates the easy and rapid acquisition of MR safety information for IMDs, thereby improving the safety of MRI examinations.

Effective Use of Foreign Clinical Data in Approvals for Medical Devices in Japan

Initial clinical development of medical devices occurs mainly in the USA and EU, with many medical devices registered in Japan afterwards. As the clinical performance of medical devices is less sensitive to ethnicity than the efficacy and safety of a drug, the performance of such devices can often be evaluated using foreign clinical data. The factors affecting the requirement for Japanese clinical data was investigated in the Japanese approvals of 103 high-risk devices, occurring between April 2005 and March 2015. The requirement for Japanese clinical data was associated with no approval in the USA and EU and the absence of foreign clinical data in the submission (p<0.001). Our results suggest that Japanese clinical data are not an essential requirement when foreign clinical data are included in the Japanese data package for approval, although, for 50% of devices with approval in the USA or EU, Japanese clinical data were still required for the Japanese approval. Reasons for this included the possibility that the performance of the device was sensitive to ethnicity associated with the medical environment, and that the device had been updated from the original one.https://doi.org/10.21423/jrs-v05n01p035 (DOI assigned 4/17/2019)

Pilot program of cost effectiveness evaluation of pharmaceuticals and medical devices in Japan

Pilot program of cost effectiveness evaluation of pharmaceuticals and medical devices in Japan

「ISO/TC 198（ヘルスケア製品の滅菌） ―本邦における “ヘルスケア製品の滅菌” の国際標準化への取り組み―」

「ISO/TC 198（ヘルスケア製品の滅菌） ―本邦における “ヘルスケア製品の滅菌” の国際標準化への取り組み―」

PHP107 - Economic Evaluation Guideline for Pharmaceuticals and Medical Devices in Japan

PHP107 - Economic Evaluation Guideline for Pharmaceuticals and Medical Devices in Japan