China 
Africa 
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Policy and regulations in rehabilitation engineering
Published in Alex Mihailidis, Roger Smith, Rehabilitation Engineering, 2023
While more critical to biomedical engineers, medical device regulations also impact rehabilitation engineering technologies and assistive technologies. Such regulations are enforceable in the jurisdiction where they apply and set standards and processes that must be met in order to make available a medical device for human use. Most regulations apply even if the device is provided at no charge, and they are primarily aimed at providing a basic level of quality, effectiveness, and safety to users of those devices and the public. The frameworks for most medical device regulations have mostly been harmonized internationally (again to facilitate trade) around key elements:Global medical device nomenclature (GMDN) – a number and description of a type of medical device.Classes (e.g., low-risk Class 1 to high-risk Class III (or active implantable devices)).Conformity assessment (verification of the manufacturing efficacy, and similar to good manufacturing practice requirements for quality control).Vigilance (early identification of problems and taking corrective action).Surveillance (ensuring that manufacturers/providers meet their obligations).
Regulatory convergence of medical devices: a case study using ISO and IEC standards
Published in Expert Review of Medical Devices, 2018
Kuniki Imagawa, Yoshiaki Mizukami, Seiko Miyazaki
Medical devices in Japan are regulated by the Pharmaceuticals, Medical Devices, and Other Therapeutic Products Act (PMD Act) which originated in November 2014 as the Revised Pharmaceutical Affairs Act. Japan has proactively incorporated GHTF documents into its regulations to achieve regulatory convergence. In the PMD Act, medical devices are classified on the basis of their risk to patients, users, and other persons, based on a GHTF document titled ‘Principles of Medical Devices Classification’ [8]. Each medical device is identified by the Japanese Medical Device Nomenclature (JMDN), which refers to Global Medical Device Nomenclature (GMDN), and they are divided into four classes, where Class I is the lowest risk and Class IV is the highest risk. There is a pre-market regulatory requirement specific to these classifications. Class I medical devices require a marketing notification by manufacturer’s self-declaration, Class II require third-party certification by the registered certification body, and Class III and IV medical devices require minister’s approval reviewed by the PMDA in most cases. Details are shown in Table 1. The third-party certification was expanded from Class II to Class III Medical Devices in the PMD Act [9].