16
Jurisdictions16
Live sites0
Planned sitesLive and Planned Sites
Each jurisdiction site covers classification, pre-market pathways, post-market obligations, and source-linked legislation and guidance.
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.
A navigation aid, not a replacement
RAPath helps teams navigate complex regulatory frameworks faster, but it is not a substitute for official sources, legal interpretation, or regulator advice.
Use RAPath to orient quickly, then verify critical requirements against current authority publications before making regulatory decisions.
Content is written with AI assistance and reviewed continuously as legislation and guidance evolve.
RAPath is for
- Regulatory affairs professionals and consultants
- Sponsors and manufacturers entering new markets
- Importers and distributors
- Anyone new to medical device regulation
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