SFDA classifies products based on statutory definitions and scientific evidence. Products may be classified as food, drug, medical device or combination. Classification decisions are valid for one year from approval. Global regulatory convergence is encouraged for cooperation
Type approval grants products meeting minimum regulatory and safety requirements. Requirements vary by country, often called homologation in Europe. Compliance can be shown by third-party markings or manufacturer certificates
HBU concept originated with Irving Fisher in real estate appraisal. Appraisal Institute defines it as legally permissible, physically possible, financially feasible use
Directive covers machinery, interchangeable equipment, safety components and lifting accessories. Excludes machinery for fairgrounds, nuclear equipment, weapons and certain transport vehicles. Defines machinery as assembly with moving parts for specific applications
MEDDEV 2.7.1 Rev 4 released July 2016, replacing 2009 version. New version focuses on European requirements rather than international harmonization. Most changes enhance guidance rather than introduce new requirements
AMM specifies maintenance procedures for aircraft systems and equipment. IPC provides detailed descriptions of aircraft components with pictures. ASM illustrates aircraft systems operation and component locations. AWM shows electrical system connections and wiring diagrams