ISAH HEALTH

International Regulatory Affairs Services

Professionals of different areas work together as an enthusiastic and committed team that is ISA HEALTH.

In ISA HEALTH we have extensive experience in regulatory affairs with health authorities in Mexico, Colombia, Costa Rica, Uruguay, Ecuador and other Latin American countries.

We offer continuous assessment on regulatory compliance requirements based on the Health Agencies regulation updates.

Our Mission

Provide regulatory support and In-Country representation for medical devices, medicines and chemicals manufacturers or dealers to facilitate national and international business development.

Our Values

Confidentiality

Honesty

Service

Commitment

Loyalty

Our Custumers

Focused on a quality and service philosophy, since 2010, we have supported an important number of manufacturers and distributors of regulated products to comply with sanitary regulations, becoming a strategic partner for the legal marketing of their products.

Regarding to Medical Device Registration we have experience with Class I, II and III Devices in:

Orthopedics
Cardiovascular
Diagnostics
Surgery
Odontology
Healing
X Ray
Rehabilitation
Between others...

Services we offer

Devices Registration (Class I, II, III) with COFEPRIS and different MOH in Latinoamerica
Renewals
Surveillance Reports
Regulatory Assessment
Free Sales Certificates
License Hosting Service for foreign manufacturers
Assessment for COFEPRIS Good Manufacturing Practices Certificate
Operation Notice, Advertising Permits, Sanitary importation Permits
Sanitary Licenses
Importation Permits
Medical Devices, Medicines (finished products and raw materials), Food, Beverages, Cosmetics, Dietary Supplements, Hazardous Chemicals.

Advertising Permits
Medical Devices, Medicines, Food, Beverages, Cosmetics, Dietary Supplements, Tobacco, Beauty Services & Health Services).

International Regulatory Affairs

We offer international services