Resources

Get the latest white papers, process charts, and other resources about medical device regulatory affairs, quality assurance, human factors, and cybersecurity requirements.

INVIMA - Colombia National Food and Drug Surveillance Institute
The Colombia National Food and Drug Surveillance Institute (Instituto Nacional de Vigilancia de Medicamentos y Alimentos or INVIMA) is regulatory
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Download the Chart on the Medical Device Approval Process in Costa Rica
Costa Rica medical device & IVD approval process
Medical device manufacturers who want to enter the Costa Rican market need to obtain approval from the Costa Rican Ministry of Health. There are a
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Costa Rica Ministry of Health Overview
The Costa Rican Ministry of Health is responsible for regulating the healthcare industry in Costa Rica. It also acts as the regulatory agency for
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Learn about the Costa Rican regulations which apply to medical devices
Costa Rica Medical Device Regulations
All documents were published by the Costa Rican Ministry of Health and are in PDF format. The Costa Rica Ministry of Health updates their database of
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Learn about the Egyptian regulations which apply to medical devices
Egypt Medical Device Regulations
Egypt's Ministry of Health and the Committee on Registration of Medical Devices have issued some important decisions regarding registration of
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MDR PMS and PSUR requirements white paper
PMS & PSUR requirements under the EU MDR
Medical device post-market surveillance (PMS) activities have already been described in the European Medical Device Directive (93/42/EEC) and are
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