ISO13485 in Chinese is called ‘medical device quality management system for regulatory requirements’ As medical devices are special products to save lives, prevent diseases and cure diseases, it is not enough to regulate them only according to the general requirements of ISO9000 standard, for this reason, ISO organisation has issued the standard of ISO13485:1996 (YY/T0287 and YY/T0288) to put forward special requirements for the quality management system of medical device manufacturers to achieve safety and effectiveness. T0287 and YY/T0288), which puts forward special requirements for the quality management system of medical device manufacturers and plays a good role in promoting the quality of medical devices to be safe and effective.
The executive version from November 2017 till now is ISO13485:2016 ‘Requirements for the use of quality management systems for medical devices for regulatory purposes’. The name and content have been changed compared to the previous version.

The Brazilian Health Regulatory Agency (ANVISA) is responsible for regulating medical device activities in Brazil. Before the product registration process can begin, the product first needs to be categorised and ANVISA classifies the product into four categories i.e. Class I, Class II, Class III and Class IV, with a rise in the risk category. In order to simplify the registration process for risky devices in lower risk categories, in September 2022 ANVISA simplified the registration process for Class I and Class II medical device products, with the previous registration pathway, Cadastro, being changed to Notification.There are two pathways for registration of products in Brazil, Notification and Registro. Products with a lower risk level (Class I and Class II products) are registered through the Notification route, while products with a higher risk level (Class III and Class IV products) can be registered through the Registro route.
Current Medical Device Regulation: RDC 751-2022 (effective 1 March 2023, repealing the previous regulation RDC 185/2001)
It must be stressed that: a. foreign companies outside of Brazil need to be certified to Brazil to find a legally authorised representative (BRH), and can only be held by the authorised representative; b. the product meets the medical device regulations and electrically charged products need to be done before applying for the INMETRO certification, with Bluetooth need to be done ANATEL certification; c. the product's registration application form, instructions, labels must be provided in Portuguese, and other technical documents can be Portuguese. c. The product's registration application form, instruction manual and labelling must be provided in Portuguese, while other technical documents can be in Portuguese, Spanish or English.

For new customers, product registration and listing services are provided at a fee; for existing customers (assisted by our 510(k) agent registration), product registration and listing services are provided free of charge.