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Regulation and more services in Ecuador

Manufacturers of medical devices (dental products, biomedical equipment, biochemical and diagnostic reagents) who wish to distribute and market their products in Ecuador must comply with Ecuadorian legislation, namely, for a medical device to enter the country it must obtain the Sanitary registration issued by the health authority (National Agency for Sanitary Regulation, Control and Surveillance – ARCSA), which is a unit of the Ministry of Public Health (MSP).

Passarini Group through its technical-legal team in Ecuador, provide you with the comprehensive advice and support you need to comply with the regulatory framework during all its stages.

In Ecuador we have the following services:

  • Registration with ARCSA/MSP of Ecuador

  • Legal Representation / Holder

  • Quality management systems Good Storage, Distribution and Transport Practices

  • Warehouses for storage

  • Foreign trade and customs

  • Trademark registration

  • Technovigilance