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

Yashika      Sharma; Dilpreet      Singh; Amrinder      Singh

doi:10.2174/2210299X01666230720103101

Abstract

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.

[1]
Bedi, O.; Krishan, P.; Singh, G. Regulatory requirements for medical devices: An insight. Appl. Clin. Res. Clin. Trials Regul. Aff.,  2017, 4(1), 16-25.
 [http://dx.doi.org/10.2174/2213476X03666160804153513]

[2]
Saini, K.S.; Kaushik, A.; Anil, B.; Rambabu, S. Harmonized medical device regulation: Need, challenges, and risks of not harmonizing the regulation in Asia. J. Young Pharm.,  2010, 2(1), 101-106.
 [http://dx.doi.org/10.4103/0975-1483.62221] [PMID: 21331201]

[3]

Medical device regulations: global overview and guiding principles; World Health Organization, 2003. 

[4]
Brolin, S. Global regulatory requirements for medical devices. Mälardalen University,  Available from:http://cncamda.org/uploadfile/upload/file/20130520/2013052016050363363.pdf

[5]
Hauser, R.G.; Kallinen, L.M.; Almquist, A.K.; Gornick, C.C.; Katsiyiannis, W.T. Early failure of a small-diameter high-voltage implantable cardioverter-defibrillator lead. Heart Rhythm,  2007, 4(7), 892-896.
 [http://dx.doi.org/10.1016/j.hrthm.2007.03.041] [PMID: 17599673]

[6]
Hauser, R.G.; Abdelhadi, R.; McGriff, D.; Retel, L.K. Deaths caused by the failure of Riata and Riata ST implantable cardioverter-defibrillator leads. Heart Rhythm,  2012, 9(8), 1227-1235.
 [http://dx.doi.org/10.1016/j.hrthm.2012.03.048] [PMID: 22449741]

[7]

Labour and welfare, 2016. Available from: http://www.mhlw.go.jp/ staff/shinai/2r9852000002f163-att/2r9852000002fev7.pdf

[8]
Chen, Y.J.; Chiou, C.M.; Huang, Y.W.; Tu, P.W.; Lee, Y.C.; Chien, C.H. A comparative study of medical device regulations: US, Europe, Canada, and Taiwan. Ther. Innov. Regul. Sci.,  2018, 52(1), 62-69.
 [http://dx.doi.org/10.1177/2168479017716712] [PMID: 29714608]

[9]
Kumar Gupta, S. Medical device regulations: A current perspective. J. Young Pharm.,  2015, 8(1), 06-11.
 [http://dx.doi.org/10.5530/jyp.2016.1.3]

[10]
Altenstetter, C. Global and local dynamics: The regulation of medical technologies in the European Union, Japan and the United States. 2010. Available from:https://regulation.upf.edu/dublin-10-papers/6E4.pdf

[11]
Azuma, K. Regulatory landscape of regenerative medicine in Japan. Curr. Stem Cell Rep.,  2015, 1(2), 118-128.
 [http://dx.doi.org/10.1007/s40778-015-0012-6]

[12]
Mori, K.; Watanabe, M.; Horiuchi, N.; Tamura, A.; Kutsumi, H. The role of the Pharmaceuticals and Medical Devices Agency and healthcare professionals in post-marketing safety. Clin. J. Gastroenterol.,  2014, 7(2), 103-107.
 [http://dx.doi.org/10.1007/s12328-014-0474-6] [PMID: 26183623]

[13]
Zhang, V. Who are the top medical device manufacturers in Japan in 2020? Proclinical, 2020. Available from:https://www.proclinical.com/blogs/2020-11/who-are-the-top-medical-device-manufacturers-in-japan-2020

[14]
Ono, S. Ministry of Health, Labour and Welfare (MHLW, Japan). 2007. Available from:http://regulatoryworld.blogspot.com/2015/02/regulations-in-japan-part-1.html

[15]
Medical devices approval process in Japan.  Available from:https://www.jtp.co.jp/en/sv/en-life-sciences/medical/sp-pmd/hoetoapply/

[16]
Medical devices. 2022. Available from:https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices.html

[17]
About medical devices. 2022. Available from:https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/about-medical-devices.html

[18]
Organizational Structure. 2022. Available from:https://www.canada.ca/en/parole-board/corporate/organizationalstructure.html

[19]
Titcombe, S. Top 10 Medical Technology (MedTech) startups in Canada. 2021. Available from: https://www.vcbay.news/2021/03/23/top-10-medical-technology-startups-in-canada/

[20]
Ikeno, F.; Ikeda, K.; Uchida, T. Patient access to medical devices—what about Japan, the second largest medical device market? Cardiovasc. Interv. Ther.,  2014, 29(1), 1-3.
 [http://dx.doi.org/10.1007/s12928-013-0202-z] [PMID: 23975639]

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DOI https://dx.doi.org/10.2174/2210299X01666230720103101	Print ISSN 2210-299X
Publisher Name Bentham Science Publisher	Online ISSN 2210-3007

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