ABSTRACT
The quality control of biomedical equipment is governed by the Indian National Standard, which was developed by the Bureau of Indian Standards (BIS), while Rule 125A of the Medical Equipment Act of 2017 is responsible for enforcing this regulation. In India, the Central Licensing Authority is the authority in charge of the approval process for any biomedical device. In the United States, the Food and Drug Administration (FDA) is the regulatory body responsible for approving medical devices and in vitro diagnostics (IVDs), whereas, in Europe, the European Commission is the regulatory authority responsible for the approval of biomedical devices and quality control of these devices. In the United States, quality control is governed by the 21st Century Federal Rules (21 CFR), whereas, in India, it is governed by the Indian Standards (IS), and in Europe it is governed by the Conformité Européenne (CE) or EN rules. In the United States, any medical device needs to be approved through the 510(k) process. A 510(k) is a document that is solely used for pre-notification and is made up of technical information. The harmonisation of the regulation on quality control that was produced by the International Standard Organization (ISO) and the ISO 13485 (2003) standard is highly specific to medical devices and is applicable to all countries. In this chapter, we explore the many regulations that pertain to the quality and regulation of various biomedical devices.
