Addressing the challenges of medical device registration in the Dominican Republic – requirements, t

Knowledge of response times, requirements that must be met, trademarks and samples is crucial for obtaining sanitary registration of medical devices in the Dominican Republic, so it is important to understand the regulatory framework that underpins the registration of these products in the country. The regulations for medical devices in the Dominican Republic are established in the General Health Law 42-01 and Decree 246-06 (Regulation on Medicines); according to this legislation, medical devices are known as sanitary products. This article summarises the minimum requirements for registration, the rules for trademarks and sample submission, the approval timeframes, and the simplified procedure for sanitary registration.

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