What We Offer
What We Offer
1. MDACS Listing Application: Device classification · Pathway assessment (recognized jurisdiction route / Conformity Assessment Body route) · Full dossier preparation and submission · Progress tracking
1. MDACS Listing Application: Device classification · Pathway assessment (recognized jurisdiction route / Conformity Assessment Body route) · Full dossier preparation and submission · Progress tracking
2. LRP (Local Responsible Person) Services: Acting as statutory LRP · COP-01 compliance (adverse event reporting, vigilance records, 7-year documentation, recall coordination) · Day-to-day DH liaison
2. LRP (Local Responsible Person) Services: Acting as statutory LRP · COP-01 compliance (adverse event reporting, vigilance records, 7-year documentation, recall coordination) · Day-to-day DH liaison
3. 2027 Registration Readiness: Importer/distributor status review · Registration timing and pathway planning · Compliance gap assessment
3. 2027 Registration Readiness: Importer/distributor status review · Registration timing and pathway planning · Compliance gap assessment
Hong Kong's Medical Device Administrative Control System (MDACS) is transitioning from voluntary to mandatory: since March 2026, Department of Health procurement requires listed devices; from 2027, all Local Responsible Persons (LRPs), importers and distributors must register. Early compliance means early market access.
Hong Kong's Medical Device Administrative Control System (MDACS) is transitioning from voluntary to mandatory: since March 2026, Department of Health procurement requires listed devices; from 2027, all Local Responsible Persons (LRPs), importers and distributors must register. Early compliance means early market access.
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