Japan Private Import Medical Device

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1806 Private importation of drugs, cosmetics, etc.(FAQ) - Japan …

https://www.customs.go.jp/english/c-answer_e/imtsukan/1806_e.htm

The Act on Securing Quality, Efficacy and Safety of Pharmaceuticals, Medical Devices, Regenerative and Cellular Therapy Products, Gene Therapy Products, and Cosmetics Law provides that the importation of drugs, quasi-drugs, cosmetics or medical equipments for …

Private Import with Doctor's license of unapproved medical …

https://www.j-mdc.com/en/import/index.php

9005 For Overseas Travelers (Quasi-drugs/ Cosmetics, …

https://www.customs.go.jp/english/c-answer_e/sonota/9005_e.htm

Import of narcotic and psychotropic drugs is prohibited for private individuals, excluding cases of import for medical use by the person, bringing in such a drug under …

Importing or Bringing Medication into Japan for Personal …

https://www.mhlw.go.jp/english/topics/import/index.html

Importing or Bringing Medication into Japan for Personal Use. Compliance and Narcotics Division, Pharmaceutical and Food Safety Bureau, Ministry of Health, Labour …

Ministry of Health, Labour and Welfare: Information for …

https://www.mhlw.go.jp/english/policy/health-medical/pharmaceuticals/01.html

Drugs, Quasi drugs. You can bring your personal medicines into Japan once certain procedures are completed. This is because there are patients who need continuous …

Authorization of Medical Devices in Japan - Johner Institute

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

Table 1: Classification of medical devices in Japan with examples. In contrast to the EU but like in the USA, devices are classified using predefined product codes: the Japanese Medical Device …

Importing Medical Devices - Japan Importer of Record …

https://www.covue.com/japan-ior/importing-medical-devices-into-japan/

Importing medical devices into Japan requires PMDA approval. If you are a foreign company without Japanese subsidiary, you are required to have a medical device licensed Japanese importer of record (IOR). Process for …

An Overview of Medical Device Regulations in Japan

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

In Japan, pharmaceuticals and medical devices are regulated by the Pharmaceutical and Medical Device Agency (PMDA) and the Ministry of Health, Labor, and Welfare (MHLW). The PMDA is an …

Business Licenses for Medical Devices｜Japan MDC, LLC

https://www.j-mdc.com/en/license/index.php

Medical device manufacturers must have appropriate licensing or accreditation when a medical device manufactured at their facilities is registered in Japan. For domestic manufacturers, a Medical Device …

Importing Non-Approved Medical Devices Into Japan: A Guide

https://www.pacificbridgemedical.com/news-brief/importing-non-approved-medical-devices-into-japan-a-guide/

Importing Non-Approved Medical Devices Into Japan: A Guide. May 2, 2001 Leave a comment. The importation of medical devices that have not yet been approved …

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