As the third-largest medical device market in Latin America, Colombia, with a population exceeding 50 million, presents a significant opportunity for international medical device companies. Over 80% of its medical devices and IVDs are supplied by foreign manufacturers, underscoring the importance of INVIMA Colombia Medical Device Registration for those looking to expand their footprint in this key market.
FDA’s 2025 user fee guidance updates small business fee waiver rules, detailing financial hardship criteria and replacing Forms 3602/3602A with Form 3602N. It supports small medical device companies by clarifying eligible documentation, including for entities in tax-exempt jurisdictions, to ease FDA registration costs and encourage market entry.
This video explains Brazil’s new UDI requirements under ANVISA and the upcoming compliance deadlines that start July 10, 2025 for Class IV devices.
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