Medical Device ISO 14971 Risk Management Training Services.

QSR 820 system counselling in the United States, BGMP system counselling in Brazil, JGMP system counselling in Japan, KGMP system counselling in Korea, UKCA QMS system counselling in the United Kingdom, FDA factory inspection counselling in the United States; and medical device system counselling in other countries.

MDSAP, Medical Device Single Audit Program MDSAP is a third party audit and assessment programme developed by the IMDRF organisation in 2014 to improve the safety and surveillance of medical devices for trade, resources and services. The aim is to achieve uniform recognition among different MDSAP member countries (TGA Australia, ANVISA Brazil, FDA USA, HC Canada, MHLW & PMDA Japan) through a single audit process.

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.