References in English

• Medical devices
  • PMDA. portal for medical devices
  • https://www.pmda.go.jp/english/pnavi_e-06.html 
• Regulations and Approval/Certification of Medical Devices
  • PMDA. portal for regulations of medical devices
  •  https://www.pmda.go.jp/english/review-services/reviews/0004.html 
• Reviews
  • PMDA. review process for drug, medical device, and regenerative medicines
  • https://www.pmda.go.jp/english/review-services/reviews/0001.html 
• Criteria for medical devices
  • PMDA. about class, JMDN for medical device and IVD
  • https://www.std.pmda.go.jp/stdDB/index_en.html 
• Consultations
  • PMDA. about PMDA consultation
  • https://www.pmda.go.jp/english/review-services/consultations/0002.html 
• Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices
  • PMD Act shown both in Japanese and English
  • https://www.japaneselawtranslation.go.jp/ja/laws/view/3213 
• IMDRF
  • International medical device regulators forum
  • Regulators in major markets are members of IMDRF.
  •  https://www.imdrf.org/
• U.S.-Japan Regulatory Collaboration
  • “Medical device developers are encouraged to discuss their single-protocol clinical study approach with both the FDA and Japanese regulatory authorities.” 
  • https://www.fda.gov/medical-devices/cdrh-international-affairs/us-japan-regulatory-collaboration 
• Review Reports: Medical Devices
  • PMDA. review reports shown both in Japanese and English
  • https://www.pmda.go.jp/english/review-services/reviews/approved-information/devices/0003.html 
• JFMDA; The Japan Federation of Medical Devices Association
  • JFMDA. industry body for medical devices
  •  https://www.jfmda.gr.jp/en/
  • The Code of Ethics/The Promotion Code/Transparency Guidelines
  • https://www.jfmda.gr.jp/en/promotioncode/ 
• J-GoodTech
  • SME Support Japan. company search and matching portal
  • https://jgoodtech.smrj.go.jp/pub/en/
• Directory of Medical Device Companies
  • JETRO.  
  • https://www.jetro.go.jp/ext_images/en/mjcompany/directory/Japan_medical_2rv.pdf
• Academic societies in Japan
  • JST. list of academic societies in Japan
  •  https://www.jst.go.jp/kousei_p/en/academic_societies.html
• AMED registered VC
  • AMED. registered VC contact list
  • https://www.amed.go.jp/en/program/list/19/02/005_Capital.html 
• Japan CRO Association
  • JCROA. member list
  • https://www.jcroa.or.jp/english/member/ 

 
©K.Kamitani