What It Is

K-PIPA, or Personal Information Protection Act, is South Korea's comprehensive data privacy regulation enacted in 2011 with major amendments in 2020, 2023, and 2024. It governs collection, use, storage, transfer, and destruction of personal, sensitive, and unique identification information by domestic and foreign entities processing Korean residents' data. Employing a consent-centric, risk-based approach with extraterritorial reach.

Key Components

• Core principles: transparency, purpose limitation, data minimization, accountability via mandatory Chief Privacy Officers (CPOs).
• Data subject rights: access, rectification, erasure, portability, objection to automated decisions (10-day responses).
• Security: encryption, access controls, 72-hour breach notifications.
• No certification model; enforced by PIPC with fines up to 3% revenue.

Why Organizations Use It

Legal compliance avoids massive fines (e.g., Google's KRW 70B); enables market access, builds trust, supports EU adequacy for transfers. Mitigates risks from breaches, enhances governance.

Implementation Overview

Phased: gap analysis, CPO appointment, data mapping, technical controls, training, audits. Applies to all data handlers globally targeting Koreans; no certification but PIPC guidelines and ISMS-P aid compliance.

What It Is

ISO 13485:2016 is the international standard titled Medical devices — Quality management systems — Requirements for regulatory purposes. It is a certifiable QMS framework specifically for medical device organizations, emphasizing risk-based controls to ensure devices meet customer and regulatory requirements across the lifecycle, from design to post-market surveillance.

Key Components

• Organized into Clauses 4–8: QMS/documentation (4), management responsibility (5), resources (6), product realization (7), measurement/improvement (8).
• Over 20 documented procedures required, built on process approach and ISO 9001 compatibility.
• Core principles: traceability, validation, risk management (per ISO 14971), and regulatory integration.
• Third-party certification via accredited bodies with stage 1/2 audits and surveillance.

Why Organizations Use It

• Enables market access (EU MDR, FDA QMSR alignment by 2026).
• Reduces risks like recalls via supplier controls and CAPA.
• Builds stakeholder trust and competitive edge in supply chains.

Implementation Overview

• Phased: gap analysis, documentation, training, validation, audits.
• Applies to manufacturers, suppliers globally; scales by size.
• Involves eQMS, cross-functional teams; certification every 3 years. (178 words)