RAPath Global Hub

ARTG inclusion, Essential Principles, conformity assessment under the Therapeutic Goods Act.

CE marking, Notified Bodies, UDI and EUDAMED under MDR 2017/745 and IVDR 2017/746.

Medical Device Licence, Class I–IV classification, MDSAP recognition.

Product registration via SHARE, Class A–D framework, Dealer's Licence.

UKCA marking, UK Approved Bodies, post-Brexit regulatory framework.

510(k), PMA, De Novo pathways, quality system (QMSR), and UDI under 21 CFR.

Shonin approval, MAH licensing requirements, PMD Act classification.

MedDO regulatory framework, conformity assessment, mutual recognition with EU.

Registration pathways, Class I–III framework, CIMDN nomenclature.

Medical Devices Rules 2017, SUGAM portal registration, Class A–D.

Medical Devices Act, Class I–IV classification, UDIKOREA registration.

RDC registration framework, Class I–IV, STED technical documentation.

Medical Device Act 2012, MeDC@St registration, ASEAN harmonisation.

REGALKES registration, Class A–D framework, Kemenkes regulatory overview.

Circular 46 registration, Class A–D classification, Ministry of Health.

GRLS state register, Class 1–3 framework, Federal Law 323-FZ.

WAND database registration, Class I–IV classification

Medical device registration via the SFDA portal, Class A–D risk classification

Registro Sanitario via COFEPRIS, Class I–III classification, NOM standards