Passarini Blog
Publication of #RDC No. 810 modifies RDC No. 751
The Future of Importation: The Impact of ANVISA's New Resolution on the Medical Devices Sector. ANVISA has recently published a new resolution that alters the rules for importing medical devices, including their accessories, into Brazil. This resolution, RDC No. 810/2023, aims to facilitate access for [...]
FDA announces annual fee for fiscal year 2024
FDA Announces Annual Fee Adjustment for Medical Devices. The FDA (Food and Drug Administration) announced the new fees for Fiscal Year 2024 (FY24) in the last week, on August 9th, 2023. Owners or operators of establishments that are involved in the production and distribution of [...]
Exponential Growth: The Medical Device Market in Colombia
Exponential Growth: The Medical Device Market in Colombia The medical device market in Colombia has experienced significant growth in recent years, driven by various factors. According to data from the Ministry of Health and Social Protection of Colombia, the medical device sector has seen an [...]
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 [...]
