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Regulatory Compliance

What is Regulatory Compliance?

The process of adhering to laws and regulations relevant to an organisation's operations. Non-compliance can result in fines, legal action, and reputational damage.

Compliance

What the standards actually require on regulatory compliance

Requirements naming regulatory compliance across 6 standards, quoted from the control text.

Article 15 requires manufacturers to have permanently available within their organisation at least one Person Responsible for Regulatory Compliance (PRRC) with the requisite expertise in the field of in vitro diagnostic medical devices.

IVDR-Art.15 · Person Responsible for Regulatory Compliance (Article 15)

Accountability (Sekinin 責任) is the seventh of 10 Principles per Japan AI Guidelines for Business + addresses organisational governance + clear responsibility allocation + stakeholder engagement + regulatory compliance across AI lifecycle.

JP-AIG-Accountability-Governance-AI-Inventory-Stakeholder-Engagement-Board-Reporting-Tone-at-Top · Japan AI Guidelines Accountability + Governance + AI Inventory + Stakeholder Engagement + Board Reporting + Tone at Top + AI Ethics Committee + DPO + AI Officer + Regulatory Compliance + Multi-Stakeholder

Article 15 requires manufacturers to have permanently available at least one Person Responsible for Regulatory Compliance (PRRC) with the requisite expertise. The PRRC has formal responsibility to ensure: (a) device conformity before release;

MDR-Art.15 · Person Responsible for Regulatory Compliance (Article 15)
ISMAP (Japan)1 control

ISMAP Cloud Governance establishes the management framework for Cloud Service Providers operating under ISMAP. (1) Information Security Management System (ISMS): based on ISO/IEC 27001:2022 + JIS Q 27001 (Japanese Industrial Standard equivalent) + ISMS-AC Info...

ISMAP-CloudGovernance-ISMS-RiskAssessment-SharedResponsibility-Policy-RegulatoryCompliance-RolesResponsibilities · ISMAP Cloud Governance - ISMS per ISO 27001/JIS Q 27001 + Risk Assessment + Shared Responsibility Model + Cloud Security Policy + Regulatory Compliance + Roles and Responsibilities

Regulatory compliance for cloud services. Control from NIST SP 800-190 framework, domain: NIST SP 800-190: Cloud Governance.

NIST190-04 · Regulatory compliance for cloud services

Operate AI incident reporting + regulatory compliance + public reporting + international cooperation per OECD AI Principles + applicable regulation + voluntary commitment.

OECDAI-8 · AI Incident Reporting, Regulatory Compliance, Public Reporting, and International Cooperation

Questions people ask about regulatory compliance

What is Regulatory Compliance?
The process of adhering to laws and regulations relevant to an organisation's operations. Non-compliance can result in fines, legal action, and reputational damage.
Why is Regulatory Compliance important for compliance?
Regulatory Compliance is a key concept in Compliance. Understanding regulatory compliance helps organizations meet regulatory requirements, reduce risk, and demonstrate due diligence during audits. Our compliance platform maps 686 frameworks with 311K cross-framework control mappings.
What concepts are related to Regulatory Compliance?
Key concepts related to Regulatory Compliance include Compliance, Audit. Understanding these interconnected concepts provides a more comprehensive view of Compliance requirements and helps organizations build holistic compliance programs.
Which compliance frameworks address Regulatory Compliance?
Regulatory Compliance appears in the requirement text of EU In Vitro Diagnostic Medical Devices Regulation (IVDR), Japan AI Guidelines, EU Medical Devices Regulation (MDR 2017/745), ISMAP (Japan), NIST SP 800-190. Across these standards we have identified 8 controls that name it directly, each linked to the control text on the compliance platform.
Where can I learn more about Regulatory Compliance?
Explore our compliance framework pages to see how regulatory compliance applies across different standards and regulations. Our implementation guides provide step-by-step guidance, and the compliance platform offers AI-powered analysis of how this concept maps across 686 frameworks.

See how Regulatory Compliance applies across compliance frameworks

Our platform maps 686 frameworks with 311K cross-framework control mappings. Explore how this concept is addressed across standards.

Written and maintained by Gerard Blokdyk, The Art of Service.