ISO 13485 Overview
ISO 13485 is a standard prepared by ISO/TC 210, the Technical Committee on Quality Management of Medical Devices, and was officially released by the ISO organization in July 2003 as the latest version of ISO 13485:2003. ISO 13485:2003 is a stand-alone standard that has been revised in accordance with ISO 9001:2000, with the addition and deletion of some provisions of ISO 9001:2000 in accordance with the characteristics of the medical device industry. However, organizations that are only compliant with this standard cannot claim that they are also compliant with ISO 9001:2000.
ISO 13485 covers basic safety requirements, risk assessment and analysis, clinical investigation and evaluation, post-market surveillance, customer complaint investigations, alert systems, and other technical standards.
Currently, many countries around the world rely on this standard to audit product inputs, and if you can pass this standard certification, it means that your product has been trusted by customers. For example:
Domestic: The Department of Health, Executive Yuan, implemented the Good Manufacturing Practice (GMP) for medical devices, which was finalized based on the relevant provisions of the Pharmaceutical Affairs Law, the Chinese national standard CNS 12681 (ISO 9001), and the international standard for quality assurance systems for medical devices (ISO 13485). The scope of evaluation is recognized by both domestic and imported medical device manufacturers.
The Americas
1. The United States: Manufacturers must be approved by the U.S. Food and Drug Administration (FDA) to establish a quality assurance system before they can be listed on the market, and the preamble to the regulation mentions that it is harmonized with the ISO 13485 standard.
2. Canada: A manufacturer's quality management system must be certified to ISO 13485 before it can sell its products in Canada.
Europe
In most cases, manufacturers are required to comply with ISO 13485 or EN46000.
Asia-Pacific
Each country's regulatory authority's import license application process has either explicit or non-explicit requirements for manufacturers to show proof of compliance with ISO 13485.