Passarini Blog
The Medical Device Market in Peru
The Medical Device Market in Peru Peru is a country located in South America, bordered by Ecuador, Colombia, Bolivia, Chile, and Brazil. It has a population of over 31 million people supported by the Ministry of Health (MinSa), which serves as the central regulatory entity. [...]
Anvisa changes import subject code for medical devices intended for repair or servicing
Anvisa changes import subject code for medical devices intended for repair or servicing The subject code "90370 - Import Authorization for Medical Products Used for Repair or Servicing by Legal Entities" has been deactivated. Importation for this purpose should now be done using the subject [...]
The market and regulation of medical devices in Mexico
The market and regulation of medical devices in Mexico Mexico is a country located in North America, neighboring the United States and the countries of Central America. It has more than 126 million inhabitants who have a public health system covered by the IMSS (Mexican [...]
Why should you consider Latin America as a market for your products?
Why should you consider Latin America as a market for your products? Latin America encompasses over 20 countries spread throughout North, Central, and South America, and its predominant language is Spanish, but Portuguese (Brazil) and French are also used. Over the years, Latin America has [...]
RDC 751/2022 comes into force tomorrow, March 1, 2023
RDC 751/2022 comes into force tomorrow, March 1, 2023 RDC 751/2022, which provides for risk classification, notification and registration regimes, and labeling requirements and instructions for use of medical devices, enters into force tomorrow, March 1, 2023. With the publication of RDC 751/2022, several changes [...]
UDI Implementation Deadline for Class I Devices – FDA 510(k) Exempt!
UDI Implementation Deadline for Class I Devices - FDA 510(k) Exempt! We finally reach the UDI (Unique Device Identification) implementation deadline at the Food and Drug Administration (FDA) for class I devices – 510(k) exempt. After the extension given by the FDA in July of [...]
