MedTech Terms
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    Crosswalks

    Regulator matrix

    Six major medical device regulators compared on nine topics. Each cell is a short summary; follow the linked terms for the full definition and primary sources. Always confirm details against the regulator's current text.

    Topic
    United States
    FDA (CDRH)
    European Union
    EU MDR, notified bodies
    United Kingdom
    MHRA
    Canada
    Health Canada
    Japan
    MHLW / PMDA
    Australia
    TGA
    Core law
    Federal Food, Drug, and Cosmetic Act; device rules in 21 CFR Parts 800 to 1299.
    Regulation (EU) 2017/745 (MDR), applying since May 26, 2021.
    Medical Devices Regulations 2002 (SI 2002/618), as amended for Great Britain.
    Medical Devices Regulations (SOR/98-282) under the Food and Drugs Act.
    Act on Pharmaceuticals and Medical Devices (PMD Act).
    Therapeutic Goods Act 1989 and Therapeutic Goods (Medical Devices) Regulations 2002.
    Risk classes
    Class I, II, III.
    Class I (including Is, Im, Ir), IIa, IIb, III under Annex VIII rules.
    Class I, IIa, IIb, III.
    Class I, II, III, IV.
    Class I, II, III, IV.
    Class I (including Is, Im), IIa, IIb, III, plus active implantables.
    Route to market
    Exemption, 510(k), De Novo or PMA depending on class and predicate.
    Conformity assessment, with a notified body for most classes above I, then CE marking.
    UKCA marking through a UK approved body; CE marking accepted in Great Britain under transitional arrangements.
    Medical Device Licence for Class II to IV; Class I sold under an establishment licence.
    Notification (Class I), third-party certification (many Class II), or MHLW approval after PMDA review (higher risk).
    Inclusion in the ARTG by an Australian sponsor, often using comparable overseas approvals.
    Quality system
    QMSR (21 CFR Part 820), incorporating ISO 13485:2016, effective February 2, 2026.
    QMS required by MDR Article 10, usually shown through EN ISO 13485.
    ISO 13485 based QMS assessed by the approved body.
    ISO 13485 certificate issued under MDSAP for Class II to IV.
    MHLW QMS Ministerial Ordinance, aligned with ISO 13485; MDSAP reports accepted.
    ISO 13485 based QMS; MDSAP audit reports used as evidence.
    Technical file and clinical evidence
    Submission content set by pathway; significant risk studies need an IDE.
    Technical documentation (Annexes II and III) and clinical evaluation with PMCF.
    Technical documentation and clinical evaluation reviewed by the approved body.
    Licence application with safety and effectiveness evidence scaled to class.
    Application dossier (STED format) with clinical data where required.
    Essential Principles checklist and clinical evidence held by the sponsor.
    Post-market and vigilance
    Medical Device Reporting (21 CFR Part 803), corrections and removals, recalls.
    PMS system, vigilance (Articles 87 to 92), PSUR, FSCA reporting.
    Incident reporting to MHRA; strengthened PMS requirements in force from June 16, 2025.
    Mandatory problem reporting and recall reporting under the Regulations.
    Adverse event and malfunction reporting to PMDA under the PMD Act.
    Adverse event reporting by the sponsor to the TGA.
    Device identification
    UDI on labels and data in GUDID (21 CFR Part 830).
    UDI system with registration in EUDAMED.
    Device registration with MHRA; UDI requirements being introduced.
    UDI framework under development.
    Barcode labelling based on GS1 standards.
    UDI framework and database being introduced.
    Cybersecurity
    Section 524B of the FD&C Act for cyber devices, including an SBOM, since March 29, 2023.
    Annex I requirements for software and IT security, interpreted through MDCG 2019-16.
    Assessed against essential requirements; follows international guidance.
    Health Canada premarket cybersecurity guidance.
    Cybersecurity expectations aligned with IMDRF guidance.
    TGA cybersecurity guidance tied to the Essential Principles.
    Local representative
    US agent required for foreign establishments.
    EU authorised representative for non-EU makers, plus a PRRC.
    UK Responsible Person for makers outside the UK.
    No formal representative; importers and distributors need establishment licences.
    Marketing authorisation holder in Japan; foreign makers designate one.
    Australian sponsor holds the ARTG entry.

    Other regulators

    Swissmedic (Switzerland)NMPA (China)ANVISA (Brazil)IMDRF (international harmonisation)

    Want more depth on two of these? See US FDA vs EU MDR.