Obtain premarket approval (Shonin), certification (Ninsho) and notification (Todoke) of foreign medical device (MD) and In-Vitro Diagnostics (IVD)
Entrusted MD/IVD MAH or D-MAH
-All marketing application must be submitted through either marketing authorization holder (MAH) or designated marketing authorization holder (D-MAH) on behalf of foreign manufacture so selecting a qualified partner is important.
-Compliance to ministerial ordinance No.169 (QMS) and monitoring support of Good Vigilance Practice (GVP)
The other application required by PMD Act
-Local Distributor qualification
-Storage/packing manufacture qualification
-Repair shop qualification
For your convenience we assist searching, matching and referring to local distributor.
Consultation on Japanese MD/IVD and Pharmaceutical Medical Device (PMD) Act in general
-QMS audit planning, preparation, execution, reporting and follow-up.
-Health Insurance Reimbursement Application (A1, A2, B, C1, C2)
-Maintenance/repair service for all class MD
●Ask S.K.I.Net for more detailed information about Japan regulatory affairs/PMD Act.●
Contact to:Quality&Regulatory Affairs Department Div.