Japan Medical Device Recall Regulations

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Regulatory Information | Pharmaceuticals and Medical …

https://www.pmda.go.jp/english/review-services/regulatory-info/0002.html

Issuance of Certificates for Medical Devices for Export; Revision of Japanese Medical Device QMS requirements; Procedures for Developing Post-marketing Study Plan; Principles for the Evaluation of Vaccines Against the Novel Coronavirus SARS-CoV-2; …

Notifications Related to Safety Measures (Medical …

https://www.pmda.go.jp/english/safety/info-services/devices/0007.html

Sep 13, 2022

Ministry of Health, Labour and Welfare: Pharmaceuticals …

https://www.mhlw.go.jp/english/policy/health-medical/pharmaceuticals/index.html

APEC endorsed Japan’s PMDA as a pilot Training Center for Medical Devices Regulation (March 18, 2019) To protect people from drug abuse For Travelers Illicit Drugs …

Japanese medical device recall requirements & procedure for …

https://elsmar.com/elsmarqualityforum/threads/japanese-medical-device-recall-requirements-procedure-for-foreign-manufacturers.74003/

Japan Medical Device Regulations: 1: May 10, 2018: E: IVD Classification in Japan based on the Japanese Pharmaceutical Affairs Law: Japan Medical Device …

An Overview of Medical Device Regulations …

https://www.regdesk.co/an-overview-of-medical-device-regulations-in-japan/

In Japan, pharmaceuticals and medical devices are regulated by the Pharmaceutical and …

Japan Medical Device & Pharmaceutical …

https://www.pacificbridgemedical.com/regulation/japan-medical-device-pharmaceutical-regulations/

Current Japan PMDA regulations are laid out in the Pharmaceuticals and Medical Devices Act (PMD Act), also known as the Act on Securing Quality, Efficacy …

New guidelines from Japanese regulators cover medical device ...

https://www.emergobyul.com/news/new-guidelines-japanese-regulators-cover-medical-device-cybersecurity-remanufactured-devices

February 11, 2022 Japan’s Ministry of Health, Labor and Welfare (MHLW) has published several new guidelines and clarifications touching on medical device …

mhlw.go.jp

https://www.mhlw.go.jp/file/04-Houdouhappyou-11123000-Iyakushokuhinkyoku-Shinsakanrika/regulation_medicaldevices.pdf

mhlw.go.jp

Medical Device Registration and Approval in Japan - Emergo

https://www.emergobyul.com/services/medical-device-registration-and-approval-japan

Japan's medical device regulation and approval process. Medical device companies interested in offering their products in Japan must comply with Japan's Pharmaceuticals …

Authorization of Medical Devices in Japan - Johner Institute

https://www.johner-institute.com/articles/regulatory-affairs/and-more/authorization-of-medical-devices-in-japan/

These regulations are relevant to the authorization of medical devices in Japan. “Administrative Notices” are equivalent to MDCG and FDA guidances and are not …

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Regulatory Information | Pharmaceuticals and Medical …

Notifications Related to Safety Measures (Medical …

Ministry of Health, Labour and Welfare: Pharmaceuticals …

Japanese medical device recall requirements & procedure for …

An Overview of Medical Device Regulations …

Japan Medical Device & Pharmaceutical …

New guidelines from Japanese regulators cover medical device ...

mhlw.go.jp

Medical Device Registration and Approval in Japan - Emergo

Authorization of Medical Devices in Japan - Johner Institute

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