Contact Us Contact MDREX JAPAN
Please submit using the form below
(English Only)

このフィールドは空のままにしてください。

① Company & Contact Information

Company NameRequired

Country / RegionRequired

Contact NameRequired

Job Title / Department

Email AddressRequired

Website URLRequired

Current MAH / DMAH (if applicable)

② Product Information

Product Name / Model NumberRequired

Product Overview & Intended UseRequired

Generic Name (if known)

③ Regulatory & Certification Status

Regulatory Approvals / Certifications Obtained (select all that apply)

FDA 510(k)

Certificate No.
Year

FDA PMA

Certificate No.
Year

MFDS (South Korea)

Approval No.
Year

CE Mark (MDR)

Notified Body / Class
Year

MDSAP

Certificate No.
Year

Other

Country / Authority
Year

ISO Certification (select all that apply)

ISO 13485

Certifying Body
Valid Until

Other

Standard Name
Valid Until

Countries / Regions Currently Marketed

④ Japan Market Entry

Experience in JapanRequired
No experienceIn progressPreviously approved

Business Partner in Japan
NoneLookingAlready have

Target Sales Start (approx.)
Less than 1 year1–2 years2–3 yearsMore than 3 yearsNot decided

Services Required (select all that apply)Required
Regulatory Submission (Shonin/Ninsho)Reimbursement SupportDMAH Support (QMS & GVP)MAH Support (QMS & GVP)Regulatory Gap AnalysisQMS / ISO 13485 SupportJapan Market ResearchDistributor / Partner IntroductionTechnical Document TranslationOther