Yes, there are a number of countries where you can import your medical products with simply an import permit and/or notification to the local Ministry of Health while avoiding formal regulatory approval. The big question our team at RegDesk gets asked all the time by small medical device companies is, “Are there any countries that do not require any regulations?” We heard your request. Many times it is in the best interest of these small medical device companies to identify markets with the least (regulatory) burdensome approach. Misguided decisions can lead to substantial delays to market and in many cases prevent companies from ever entering a market.įor startups and small sized companies, limited budget coupled with a lack of in-house regulatory expertise amplifies the challenge to bring their products to market. Moreover, regulations not only differ by country but are also product-specific. The regulatory landscape is dynamic rules of the road are always changing. Obtaining regulatory approval is one of the biggest hurdles faced by these companies. Global regulatory statutes significantly impact healthcare companies.
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