• Clinical Evaluation Report (CER) - Decode the Step-wise Approach for Compliance

    We appreciate your interest in Freyr’s webinar - “Clinical Evaluation Report (CER) - Decode the Step-wise Approach for Compliance.” We are happy to announce that the session was successfully completed on December 11, 2018.

    But with your keen interest on CER Authoring as per updated MED DEV 2.7/1 Rev 4, we assume you would like to go through the session. In that regard, let us share with you a FREE copy of webinar recording.

  • Medical Device Regulatory Services in Brazil

    Overview

    Brazil is one of the biggest countries in South America and Latin America. It spends hugely on healthcare boosting the Medical Devices locally. The country has established regulations in place and it governs Medical Devices through National Health Surveillance Agency (ANVISA - Agência Nacional de Vigilância Sanitária) under Ministry of Health. The registration is done through Cadastro or Registro processes basing on the device classification (Class I, II, III and IV) which also decides the extent of scrutiny involved for approval.

  • Regulatory Services in Panama

    Overview

    Being a gateway to enter Central America and the Caribbean, Panama (República de Panamá) attracts foreign medicinal products and medical device investments. Ministerio de Salud de la República de Panamá (MINSA) overlooks the registrations, licensing and product approvals for the region. Even though the region offers good business opportunities, navigating the Panama’s regulatory regime requires a complete know-how on the procedural challenges.

  • Regulatory Services in Puerto Rico

    Overview

    Geographically placed in proximity of the U.S., Puerto Rico attracts foreign investments for medicinal products. To obtain market approvals, manufacturers or new entrants must first approach Department of Health (Departamento de Salud). Unlike other states, Puerto Rico’s unique requirements for marketing or selling pharmaceutical products require a fool proof regulatory strategy from the foreign manufacturers.

  • Regulatory Services in Chile

    Overview

    Being one of the prosperous countries in South America, Chile attracts medicinal products and medical device manufacturers to invest in the region not only for its strong healthcare system, but also for modern technologies that are being implemented. To access the market, manufacturers must obtain market approvals and registrations from the Agencia Nacional de Medicamentos (ANAMED). With ever-evolving Regulations and competitive timelines, Chilean market, however, challenges foreign manufacturers to navigate the updated Regulatory procedures to fall in compliance.

  • Regulatory Services in Bolivia

    Overview

    With its rich natural resources and biodiverse landscape, the State of Bolivia offers enormous business opportunities for foreign medicinal product and medical device manufacturers. For registrations and market approvals, manufacturers are obliged to obtain authorizations from the Unidad de Medicamentos y Tecnologia en Salud (the Unit of Drugs and Health Technology or UNIMED), a division of Ministry of Health. However, navigating through challenging Regulatory regime in the region might affect manufacturers’ compliance efforts.

  • Regulatory Services in Guatemala

    Overview

    The Republic of Guatemala, a country in Central America, with its tax incentives could be a best destination for medicinal products’ and medical devices’ investments. To access the market, manufacturers must obtain licensing and market authorization approvals from the ministry’s Department for the Regulation and Control of Pharmaceuticals and Related Products which regulates the registration of Guatemalan pharmaceuticals. Though the registration lasts for five years, attaining that would require manufacturers to go through complex set of Regulatory procedures.

  • Regulatory Services in Mexico

    Overview

    Mexico stands a favorite destination for medicines and medical device manufacturers to explore the pharmaceutical market opportunities. To do so, manufacturers must obtain approvals from (Comisión Federal para la Protección contra Riesgos Sanitarios) COFEPRIS - The Federal Commission for Protection against Sanitary Risk. Enroute, foreign manufacturers might face challenges navigating the Mexican regulatory regime: Good Manufacturing Practices (GMP) and Pharmacovigilance, and other Regulatory requirements.