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 medical devices intended for use [...]
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 average annual growth of 7.6% [...]
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. The healthcare system in Peru [...]
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 code for commercial or industrial [...]
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 Institute of Social Security) and [...]
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 become of interest to medical [...]
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 were made to the regulation [...]
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 this year, moving the deadline [...]
RDC 751/2022: Risk classification, the notification and registration regimes, and the requirements for labeling and instructions for use for medical devices. Resolution - RDC no. 751, of september 15, 2022 was published yesterday (21/09) in the official Gazette of the Union, which provides for risk classification, notification and registration regimes, [...]
Anvisa updates rules for RDC nº 185/2001 - regulation of medical devices in Brazil Anvisa released on its website on Wednesday (14/09) a news informing about the update of the rules for regularization of medical devices in Brazil. According to Anvisa, the Collegiate Board approved the proposal that revises RDC 185/2001, [...]
