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